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He W, Yang H, Yang X, Huang J, Wu Z. Global research trends in biological therapy for ankylosing spondylitis: A comprehensive visualization and bibliometric study (2004-2023). Hum Vaccin Immunother 2025; 21:2445900. [PMID: 39813123 PMCID: PMC11740677 DOI: 10.1080/21645515.2024.2445900] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/13/2024] [Revised: 12/05/2024] [Accepted: 12/19/2024] [Indexed: 01/18/2025] Open
Abstract
Ankylosing spondylitis (AS) is a chronic inflammatory disease primarily affecting the spine and pelvic bones. Recently, many researchers have confirmed that biological therapy is effective for AS patients, which provides a new perspective for the treatment of AS. This study aimed to evaluate the characteristics of scientific research on AS and biological therapy worldwide and investigate research hotspots and the direction of future trends. Global literature on AS and biological therapy published from 2004 to 2023 was searched in the Web of Science, Scopus, and PubMed databases. Visualization and bibliometric analysis were carried out using the VOSviewer and CiteSpace software with the retrieved data regarding countries, institutions, journals, authors, and keywords. A total of 2,243 related articles were included, showing that the number of articles in this field has increased annually. The highest number of articles were from the USA (24.39%), followed by Italy (14.36%), England (12.19%), Germany (10.66%), and Spain (7.86%). Braun J was the most prolific author, with a h-index of 16. The institution with the most articles was Charite Universitatsmedizin Berlin, and the Rheumatology journal had the highest number of publications. "janus kinase inhibitor" and "secukinumab" displayed a notable citation burst in recent years, indicating IL-17i and JAKi are research hotspots. More and more attention has been paid to the association between AS and biological therapy in the past two decades. The USA plays a leading role, and China has made remarkable progress. This study has provided a valuable reference for future research in this field.
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Affiliation(s)
- Weiliang He
- Institute of Orthopaedics, Xijing Hospital, Air Force Medical University, Xi’an, China
| | - Haicheng Yang
- Department of General Surgery, Tangdu Hospital, Air Force Medical University, Xi’an, China
| | - Xuanzhe Yang
- Institute of Orthopaedics, Xijing Hospital, Air Force Medical University, Xi’an, China
| | - JinFeng Huang
- Institute of Orthopaedics, Xijing Hospital, Air Force Medical University, Xi’an, China
| | - Zixiang Wu
- Institute of Orthopaedics, Xijing Hospital, Air Force Medical University, Xi’an, China
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Kwan YH, Leung YY. Monitoring psoriatic arthritis in research and clinical practice. Curr Opin Rheumatol 2025; 37:233-242. [PMID: 40066761 DOI: 10.1097/bor.0000000000001089] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/29/2025]
Abstract
PURPOSE OF REVIEW To discuss the varies outcome measure instruments for the assessment of different domains for psoriatic arthritis (PsA) both in trial and clinical practice settings. RECENT FINDINGS PsA is a multifaceted chronic inflammatory disease with diverse manifestations. This pose challenges of comprehensive assessment of the outcome of PsA. The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) had developed the core domain set and in the progress of selecting the core outcome measurement set for trials and clinical practice for PsA, using the framework set by Outcome Measures in Rheumatology (OMERACT). In brief, the core set of "what to measure" has been endorsed, and a standardized way of "how to measure" them are under review. Composite outcome measures for PsA may provide a solution to measuring multiple domains in a nutshell for various purposes in trials and clinical practice. SUMMARY This provides a succinct summary of the current state of outcome measurement in PsA and provides a quick and comprehensive perspective to select relevant outcome measure to use in busy rheumatology clinical settings.
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Affiliation(s)
- Yu Heng Kwan
- Department of Rheumatology and Immunology, Singapore General Hospital
- Program in Health Services and Systems Research, Duke-NUS Medical School
- Centre of Population Health and Implementation Research, SingHealth Regional Health System
| | - Ying Ying Leung
- Department of Rheumatology and Immunology, Singapore General Hospital
- Duke-NUS Medical School, Singapore, Singapore
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Ramiro S, van der Heijde D. Annals of the Rheumatic Diseases collection on axial spondyloarthritis (2022-2024): advances in the field. Ann Rheum Dis 2025; 84:888-893. [PMID: 40307141 DOI: 10.1016/j.ard.2025.03.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/21/2025] [Revised: 03/12/2025] [Accepted: 03/18/2025] [Indexed: 05/02/2025]
Abstract
During the period from 2022 to 2024, Annals of the Rheumatic Diseases published a series of articles dedicated to significant advancements in axial spondyloarthritis (axSpA). These articles spanned across diverse areas including translational science, epidemiology, disease outcomes, imaging, management, and updated clinical recommendations and consensus statements supported by new evidence.
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Affiliation(s)
- Sofia Ramiro
- Department of Rheumatology, Leiden University Medical Center, Leiden and Zuyderland Medical Center, Heerlen, Netherlands.
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Zhao SS, Harrison SR, Thompson B, Yates M, Eddison J, Chan A, Clarke N, Corp N, Davis C, Felix L, Flora K, Gregory WJ, Jones GT, Lamb CA, Marzo-Ortega H, Murphy DJ, Petrushkin H, Sandhu V, Sengupta R, Siebert S, Van Der Windt DA, Webb D, Yiu ZZN, Gaffney K. The 2025 British Society for Rheumatology guideline for the treatment of axial spondyloarthritis with biologic and targeted synthetic DMARDs. Rheumatology (Oxford) 2025; 64:3242-3254. [PMID: 40199504 DOI: 10.1093/rheumatology/keaf089] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/31/2024] [Accepted: 01/15/2025] [Indexed: 04/10/2025] Open
Affiliation(s)
- Sizheng Steven Zhao
- Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Science, School of Biological Sciences, Faculty of Biological Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK
- NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, UK
| | - Stephanie R Harrison
- Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
- Leeds NIHR Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK
| | - Ben Thompson
- Rheumatology Department, The Newcastle-upon-Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
| | - Max Yates
- Centre for Epidemiology, Norwich Medical School, University of East Anglia, Norwich, UK
- Rheumatology Department, Norfolk & Norwich University Hospitals NHS Foundation Trust, Norwich, UK
| | | | - Antoni Chan
- University Department of Rheumatology, Royal Berkshire NHS Foundation Trust, Reading, UK
| | | | - Nadia Corp
- Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Staffordshire, UK
| | - Charlotte Davis
- Department of Rheumatology, The Leeds Teaching Hospitals NHS Trust, Leeds, UK
| | - Lambert Felix
- Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Staffordshire, UK
| | - Kalveer Flora
- Pharmacy Department, London North West University Healthcare NHS Trust, London, UK
| | - William J Gregory
- Rheumatology Department, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Greater Manchester, UK
- Faculty of Health and Education, Manchester Metropolitan University, Manchester, UK
| | - Gareth T Jones
- Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen, UK
| | - Christopher A Lamb
- Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
- Department of Gastroenterology, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
| | - Helena Marzo-Ortega
- Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
- Leeds NIHR Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK
| | - Daniel J Murphy
- Honiton Surgery, Department of Rheumatology, Royal Devon & Exeter Hospital, Exeter, UK
| | - Harry Petrushkin
- Uveitis and Scleritis Service, Moorfields Eye Hospital NHS Foundation Trust, London, UK
| | - Virinderjit Sandhu
- Department of Rheumatology, St George's University Hospitals NHS Foundation Trust, London, UK
| | - Raj Sengupta
- Royal National Hospital for Rheumatic Diseases, Royal United Hospitals, Bath, UK
| | - Stefan Siebert
- School of Infection and Immunity, University of Glasgow, Glasgow, UK
| | | | - Dale Webb
- National Axial Spondyloarthritis Society (NASS), London, UK
| | - Zenas Z N Yiu
- Dermatology Centre, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK
| | - Karl Gaffney
- Rheumatology Department, Norfolk & Norwich University Hospitals NHS Foundation Trust, Norwich, UK
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5
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Zhao SS, Harrison SR, Thompson B, Yates M, Eddison J, Chan A, Clarke N, Corp N, Davis C, Felix L, Flora K, Gregory WJ, Jones GT, Lamb CA, Marzo-Ortega H, Murphy DJ, Petrushkin H, Sandhu V, Sengupta R, Siebert S, Van Der Windt DA, Webb D, Yiu ZZN, Gaffney K. Executive Summary: The 2025 British Society for Rheumatology guideline for the treatment of axial spondyloarthritis with biologic and targeted synthetic DMARDs. Rheumatology (Oxford) 2025; 64:3234-3241. [PMID: 40199508 DOI: 10.1093/rheumatology/keaf090] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/23/2025] [Accepted: 01/23/2025] [Indexed: 04/10/2025] Open
Affiliation(s)
- Sizheng Steven Zhao
- Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Science, School of Biological Sciences, Faculty of Biological Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK
- NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, UK
| | - Stephanie R Harrison
- Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
- Leeds NIHR Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK
| | - Ben Thompson
- Rheumatology Department, The Newcastle-upon-Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
| | - Max Yates
- Centre for Epidemiology, Norwich Medical School, University of East Anglia, Norwich, UK
- Rheumatology Department, Norfolk & Norwich University Hospitals NHS Foundation Trust, Norwich, UK
| | | | - Antoni Chan
- University Department of Rheumatology, Royal Berkshire NHS Foundation Trust, Reading, UK
| | | | - Nadia Corp
- Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Staffordshire, UK
| | - Charlotte Davis
- Department of Rheumatology, The Leeds Teaching Hospitals NHS Trust, Leeds, UK
| | - Lambert Felix
- Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Staffordshire, UK
| | - Kalveer Flora
- Pharmacy Department, London North West University Healthcare NHS Trust, London, UK
| | - William J Gregory
- Rheumatology Department, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Greater Manchester, UK
- Faculty of Health and Education, Manchester Metropolitan University, Manchester, UK
| | - Gareth T Jones
- Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen, UK
| | - Christopher A Lamb
- Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
- Department of Gastroenterology, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
| | - Helena Marzo-Ortega
- Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
- Leeds NIHR Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK
| | - Daniel J Murphy
- Honiton Surgery, Department of Rheumatology, Royal Devon & Exeter Hospital, Exeter, UK
| | - Harry Petrushkin
- Uveitis and Scleritis Service, Moorfields Eye Hospital NHS Foundation Trust, London, UK
| | - Virinderjit Sandhu
- Department of Rheumatology, St George's University Hospitals NHS Foundation Trust, London, UK
| | - Raj Sengupta
- Royal National Hospital for Rheumatic Diseases, Royal United Hospitals, Bath, UK
| | - Stefan Siebert
- School of Infection and Immunity, University of Glasgow, Glasgow, UK
| | | | - Dale Webb
- National Axial Spondyloarthritis Society (NASS), London, UK
| | - Zenas Z N Yiu
- Dermatology Centre, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK
| | - Karl Gaffney
- Rheumatology Department, Norfolk & Norwich University Hospitals NHS Foundation Trust, Norwich, UK
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Liu F, Lu C, Kuo C, Liao H, Lee S, Su K, Sung W, Tsai W, Chen H, Chen H, Wei JC, Tseng J, Weng M, Chen H, Hsieh S. Clinical Response to Adalimumab Therapy and Its Determinants in Patients With Radiographic Axial Spondyloarthritis: A Prospective Real-World Study in Taiwan. Int J Rheum Dis 2025; 28:e70285. [PMID: 40443026 PMCID: PMC12123172 DOI: 10.1111/1756-185x.70285] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/19/2024] [Revised: 04/14/2025] [Accepted: 05/08/2025] [Indexed: 06/02/2025]
Abstract
AIM To investigate the clinical response to adalimumab (ADA) in patients with active radiographic axial spondyloarthritis (r-axSpA) in Taiwan. METHODS In this real-world study, patients with r-axSpA, starting ADA therapy, were enrolled and followed up every 12 weeks for 48 weeks. Outcome parameters were the proportion of patients with an improvement of 50% in Bath ankylosing spondylitis disease activity index (BASDAI50), inactive disease (ID, < 1.3), and low disease activity (LDA, < 2.1) per ankylosing spondylitis disease activity score-C-reactive protein (ASDAS-CRP) and ASDAS-erythrocyte sedimentation rate (ASDAS-ESR), and change in peripheral and extra-musculoskeletal manifestations. Determinants of BASDAI50 response to ADA were examined. Treatment-emergent adverse events (TEAEs) were recorded. RESULTS Of 88 enrolled patients, 86 were analyzed, and 82 completed the study with all patients receiving 40 mg ADA fortnightly. Patients achieving BASDAI50 increased from 79.1% to 80.5% from weeks 12 to 48. At week 48, ASDAS-CRP and -ESR, ID, and LDA were improved from baseline in 60.8%, 74.7%, 42.1%, and 68.4% of patients, respectively. A decrease in enthesitis, peripheral arthritis, dactylitis, and uveitis was noted. Younger age, presence of uveitis, and use of conventional synthetic disease-modifying antirheumatic drugs were the determinants of treatment response. At least one TEAE was reported in 22.7%, serious AEs in 2.3% of patients, and no deaths. The most common TEAEs were upper respiratory tract infection (5.7%) and cough (3.4%). CONCLUSIONS This real-world, prospective study in Taiwan involving patients with active r-axSpA shows that ADA treatment effectively reduced disease activity and improved physical function. No new safety concerns were noted.
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Affiliation(s)
- Feng‐Cheng Liu
- Division of Rheumatology, Immunology, and Allergy, Department of Internal MedicineTri‐Service General Hospital, National Defense Medical CenterTaipeiTaiwan
| | - Cheng‐Hsun Lu
- Division of Rheumatology, Immunology, and Allergy, Department of Internal MedicineNational Taiwan University HospitalTaipeiTaiwan
| | - Chang‐Fu Kuo
- Division of Rheumatology, Allergy and Immunology, Department of Internal MedicineChang Gung Medical Foundation, Linkou BranchTaoyuanTaiwan
| | - Hsien‐Tzung Liao
- Division of Allergy, Immunology and Rheumatology, Department of MedicineTaipei Veterans General HospitalTaipeiTaiwan
| | - Shinn‐Shing Lee
- Department of Medicine—Allergy, Immunology and RheumatologyCheng Hsin General HospitalTaipeiTaiwan
| | - Kuei‐Ying Su
- Division of Allergy, Immunology and Rheumatology, Hualien Tzu Chi HospitalBuddhist Tzu Chi General HospitalHualienTaiwan
| | - Wan‐Yu Sung
- Division of Rheumatology, Department of Internal MedicineKaohsiung Medical University Chung‐Ho HospitalKaohsiungTaiwan
| | - Wen‐Chan Tsai
- Division of Rheumatology, Department of Internal MedicineKaohsiung Medical University Chung‐Ho HospitalKaohsiungTaiwan
| | - Hsin‐Hua Chen
- Division of Allergy, Immunology and Rheumatology, Department of Internal MedicineTaichung Veterans General HospitalTaichungTaiwan
| | - Hung‐An Chen
- Division of Rheumatology, Department of Internal MedicineChi Mei Medical CenterTainanTaiwan
| | - James Cheng‐Chung Wei
- Department of Allergy, Immunology & RheumatologyChung Shan Medical University HospitalTaichungTaiwan
| | - Jui‐Cheng Tseng
- Division of Rheumatology, Allergy and Immunology, Department of Internal MedicineKaohsiung Veterans General HospitalKaohsiungTaiwan
| | - Meng‐Yu Weng
- Division of Allergy, Immunology, and Rheumatology, Department of Internal MedicineNational Cheng Kung University HospitalTainanTaiwan
| | - Hsiang‐Cheng Chen
- Division of Rheumatology, Immunology, and Allergy, Department of Internal MedicineTri‐Service General Hospital, National Defense Medical CenterTaipeiTaiwan
| | - Song‐Chou Hsieh
- Division of Rheumatology, Immunology, and Allergy, Department of Internal MedicineNational Taiwan University HospitalTaipeiTaiwan
- Department of Internal MedicineNational Taiwan University Cancer CentreTaipeiTaiwan
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7
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Binh BH, Phuong NTT, Hang VTT, Nhan NTT, Hoa NTN, Van Dung H. Personalized dose reduction strategies for biologic disease-modifying antirheumatic drugs for treating axial spondyloarthritis: a clinical and economic evaluation with predictive modeling. BMC Rheumatol 2025; 9:60. [PMID: 40420244 DOI: 10.1186/s41927-025-00516-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/28/2025] [Accepted: 05/19/2025] [Indexed: 05/28/2025] Open
Abstract
BACKGROUND Axial spondyloarthritis (AS) is a chronic inflammatory disease that significantly affects quality of life and imposes a high economic burden on patients due to the cost of biologic disease-modifying antirheumatic drugs (bDMARDs). Dose reduction strategies for bDMARDs may offer a feasible approach to maintaining clinical efficacy while reducing costs. This study aimed to evaluate the clinical effectiveness and cost-efficiency of bDMARD dose reduction in patients with AS and apply machine learning to identify key factors influencing disease control. METHODS This 12-month prospective study, 368 AS patients receiving ≥ 3 months of full-dose bDMARDs were included. Among 215 initial responders (ASDAS < 2.1), 146 underwent dose reduction while 69 continued full-dose therapy. Clinical outcomes such as C-reactive protein (CRP) levels, the Bath ankylosing spondylitis disease activity index (BASDAI) and ankylosing spondylitis disease activity score (ASDAS) were assessed, along with cost effectiveness using incremental cost effectiveness ratios (ICER). Random forest models were developed to predict the achievement of inactive disease (ASDAS < 1.3) and to identify key predictors. RESULTS The dose reduction group demonstrated significantly greater improvements in CRP (-4.05 vs. +2.83 mg/L, p < 0.001), BASDAI (-3.00 vs. +0.89, p < 0.001), and ASDAS (-1.42 vs. +0.09, p < 0.001) compared to the full dose group. A greater proportion of patients in the reduced dose group achieved ASDAS < 1.3 at 12 months (93.2% vs. 33.3%, p < 0.001), with a shorter median time to response (4.20 vs. 4.70 months, p < 0.001). The ICER for achieving ASDAS < 1.3 was favorable (-$6,209.78; 95% CI:-$9,048.35 to-$4,015.78), supporting the cost-effectiveness of dose reduction. A random forest model identified reduced dose strategy, baseline ASDAS, BASDAI, treatment duration, and CRP as key predictors of ASDAS < 1.3, achieving an AUC of 0.845 and F1-score of 0.774. CONCLUSIONS In this cohort, bDMARD dose reduction was associated with preserved clinical outcomes and lower costs, suggesting it may be a viable strategy for selected patients under close clinical supervision. Predictive modeling provided actionable insights to optimize personalized treatment strategies, balancing efficacy and economic sustainability. These findings support further evaluation of dose reduction strategies, especially in resource-limited settings, to inform potential integration into routine practice.
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Affiliation(s)
- Bui Hai Binh
- Centre of Rheumatology, Bach Mai Hospital, Hanoi, 100000, Vietnam
| | - Nguyen Thi Thu Phuong
- Hai Phong University of Medicine and Pharmacy, Hai Phong, 180000, Vietnam
- Department of Pharmacy, Hai Phong International Hospital, Hai Phong, 180000, Vietnam
| | | | | | - Nguyen Thi Nhu Hoa
- Centre of Rheumatology, Bach Mai Hospital, Hanoi, 100000, Vietnam
- Internal Medicine Department, University of Medicine and Pharmacy, Hanoi, 100000, Vietnam
| | - Hoang Van Dung
- Department of Internal Medicine, Hai Phong International Hospital, Hai Phong, 180000, Vietnam.
- Hai Phong International Hospital, Head of Department of Internal Medicine, Hai Phong International Hospital, 124 Nguyen Duc Canh, Le Chan, Hai Phong, Viet Nam.
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8
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Berg IJ, Kristianslund EK, Tveter AT, Sexton J, Bakland G, Gossec L, Hakim S, Macfarlane GJ, Moholt E, Provan SA, Thomassen EEK, de Thurah A, Haavardsholm EA, Lillegraven S, Osteras N. Remote monitoring or patient-initiated care in axial spondyloarthritis: a 3-armed randomised controlled noninferiority trial. Ann Rheum Dis 2025:S0003-4967(25)00908-2. [PMID: 40413111 DOI: 10.1016/j.ard.2025.04.019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/28/2025] [Revised: 03/25/2025] [Accepted: 04/18/2025] [Indexed: 05/27/2025]
Abstract
OBJECTIVES This study aimed to determine whether novel follow-up regimen, remote monitoring, or patient-initiated care is noninferior to usual care in maintaining low disease activity, in patients with axial spondyloarthritis (axSpA). METHODS This is a randomised, controlled, 3-armed, parallel-group, open-label, noninferiority trial. Patients with axSpA in low disease activity on stable treatment with tumour necrosis factor inhibitor were recruited from a Norwegian outpatient clinic. Patients were randomly allocated 1:1:1 to remote monitoring, patient-initiated care, or usual care (control group), with 18 months of follow-up. Primary outcome was mean probability of axSpA Disease Activity Score (ASDAS) of <2.1, compared between groups at 6, 12, and 18 months, with 15% noninferiority margin. Secondary outcomes included other measures of disease activity, physical function, patient satisfaction, change of medication, resource use, and adverse events. RESULTS Of 243 patients enrolled patients, 235 completed the study (remote monitoring = 75, patient-initiated care = 79, usual care = 81). At the 6-month, 12-month, and 18-month assessments, 90% or more patients in all 3 groups had ASDAS of <2.1. The estimated difference of probability of ASDAS < 2.1 was as follows: usual care vs remote monitoring, -4.1% (97.5% CI, -9.9% to 1.8%); usual care vs patient-initiated care, -1.1% (97.5% CI, -7.2% to 4.9%); and remote monitoring vs patient-initiated care, 2.9% (95% CI, -1.5% to 7.4%). Health providers' resource use was lowest in patient-initiated care; other secondary outcomes were comparable. CONCLUSIONS In patients with axSpA in low disease activity and on stable treatment with tumour necrosis factor inhibitor, follow-up with remote monitoring or patient-initiated care was noninferior to usual care in maintaining low disease activity, supporting the implementation of novel follow-up strategies.
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Affiliation(s)
- Inger Jorid Berg
- Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.
| | - Eirik K Kristianslund
- Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
| | - Anne Therese Tveter
- Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway; Department of Rehabilitation Science and Health Technology, Oslo Metropolitan University, Oslo, Norway
| | - Joseph Sexton
- Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
| | - Gunnstein Bakland
- Department of Rheumatology, University Hospital of North Norway, Tromsø, Norway; Institute of Clinical Medicine, Faculty of Health Sciences, UiT The Arctic University of Tromsø, Tromsø, Norway
| | - Laure Gossec
- INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université, Paris, France; Rheumatology Department, AP-HP, Pitié-Salpêtrière Hospital, Paris, France
| | - Sarah Hakim
- Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
| | - Gary J Macfarlane
- Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen, United Kingdom
| | - Ellen Moholt
- Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
| | - Sella Aarrestad Provan
- Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway; Section for Public Health, Inland Norway University of Applied Sciences, Elverum, Norway
| | - Emil E Kvernberg Thomassen
- Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
| | - Annette de Thurah
- Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
| | - Espen A Haavardsholm
- Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway; Faculty of Medicine, University of Oslo, Oslo, Norway
| | - Siri Lillegraven
- Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
| | - Nina Osteras
- Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway; Faculty of Medicine, University of Oslo, Oslo, Norway
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Nasonov EL, Mazurov VI, Lila AM, Dubinina TV, Gaidukova IZ, Lapshina SA, Klimenko AA, Somov DV, Lukyanov SA, Chudakov DM, Zvyagin IV, Britanova OV, Korolev MA, Abdulganieva DI, Krechikova DG, Kastanayan AA, Eliseeva LV, Samigullina RR, Povarova TV, Antipova OV, Smakotina SA, Soboleva VN, Nesmeyanova OB, Plaksina TV, Soroka NF, Vinogradova IB, Rebrov AP, Kropotina TV, Maslyansky AL, Zinkina-Orikhan AV, Linkova YN, Pukhtinskaya PS, Morozova MA, Vinderskaya GA. The Efficacy and Safety of BCD-180, an Anti-TRBV9+ T cell Monoclonal Antibody, in Patients with Active Radiographic Axial Spondyloarthritis: 36-week Results from the Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study ELEFTA. DOKL BIOCHEM BIOPHYS 2025:10.1134/S1607672925700140. [PMID: 40353961 DOI: 10.1134/s1607672925700140] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/03/2025] [Revised: 02/09/2025] [Accepted: 02/09/2025] [Indexed: 05/14/2025]
Abstract
The study aims to evaluate the clinical efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of seniprutug (BCD-180) in patients with active radiographic axial spondyloarthritis (r-axSpA, or ankylosing spondylitis). MATERIALS AND METHODS . Two hundred sixty patients with active r-axSpA and inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) were randomized into three groups to receive either seniprutug (BCD-180) 5 or 7 mg/kg, or placebo. BCD-180 was administered in the respective group dose using a 0-12-36 week regimen. The placebo group patients were switched to BCD-180 5 mg/kg at Week 24, with therapy continued at Week 36. The primary endpoint was the proportion of patients achieving 40% improvement in the Assessment in Spondyloarthritis International Society (ASAS40) score at Week 24. The secondary endpoints included the proportion of patients achieving an ASAS20/40 response, improvement in 5 of 6 ASAS criteria (ASAS5/6), partial remission according to ASAS, ASDAS-CRP clinically important improvement in (Ankylosing Spondylitis Disease Activity Score with C-reactive protein level, ASDAS-CII) and ASDAS-CRP major improvement (ASDAS-MI). An analysis of changes over time in the disease activity status according to ASDAS-CRP, BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and BASFI (Bath Ankylosing Spondylitis Functional Index) scores, as well as changes over time in laboratory markers (CRP and erythrocyte sedimentation rate (ESR)) was also conducted. Safety was assessed based on the frequency and profile of adverse events (AE) and adverse reactions (AR). RESULTS : The proportion of patients who achieved an ASAS40 response at Week 24 on seniprutug (BCD-180) at doses of 7 and 5 mg/kg was 51.4 and 40.8%, respectively, compared with 24% in the Placebo group (p = 0.0012 and p = 0.0417, respectively). Analysis of secondary endpoints showed that the efficacy of BCD-180 at both study doses was statistically significantly superior to placebo in patients with r-axSpA at Week 24 in the following respects: reduction in the proportion of subjects with very high disease activity (ASDAS-CRP > 3.5), achieving ASDAS-CII, ASAS20, ASAS5/6 response. A statistically significant decrease in the ASDAS-CRP, BASDAI, BASFI score, as well as CRP and ESR levels was demonstrated. Tolerability of seniprutug therapy was assessed as acceptable. The most common AEs were infusion-related reactions, most of which were mild to moderate according to CTCAE 5.0 (Common Terminology Criteria for Adverse Events) and developed mainly during the first administration. The proportion of patients with detected binding antibodies was 5.1%. No neutralizing antibodies were detected. CONCLUSIONS . Seniprutug (BCD-180) as a therapy for r-axSpA has demonstrated superiority over placebo in the clinical efficacy, a good safety profile and low immunogenicity.
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Affiliation(s)
- E L Nasonov
- Nasonova Research Institute of Rheumatology, 115522, Moscow, Russia
- Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia, 119991, Moscow, Russia
| | - V I Mazurov
- Mechnikov North-West State Medical University, 198015, St. Petersburg, Russia
| | - A M Lila
- Nasonova Research Institute of Rheumatology, 115522, Moscow, Russia
- Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia, 125993, Moscow, Russia
| | - T V Dubinina
- Nasonova Research Institute of Rheumatology, 115522, Moscow, Russia
| | - I Z Gaidukova
- Mechnikov North-West State Medical University, 198015, St. Petersburg, Russia
- St. Petersburg Clinical Rheumatology Hospital No. 25, 190068, St. Petersburg, Russia
| | - S A Lapshina
- Kazan State Medical University", Ministry of Health of Russia, 420012, Kazan, Russia
- Pediatric Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan, 420064, Kazan, Russia
| | - A A Klimenko
- Pirogov Municipal Clinical Hospital No. 1, Moscow City Healthcare Department, 117049, Moscow, Russia
- Pirogov Russian National Research Medical University, Ministry of Health of Russia, 117997, Moscow, Russia
| | - D V Somov
- Pirogov Russian National Research Medical University, Ministry of Health of Russia, 117997, Moscow, Russia
| | - S A Lukyanov
- Pirogov Russian National Research Medical University, Ministry of Health of Russia, 117997, Moscow, Russia
| | - D M Chudakov
- Pirogov Russian National Research Medical University, Ministry of Health of Russia, 117997, Moscow, Russia
| | - I V Zvyagin
- Pirogov Russian National Research Medical University, Ministry of Health of Russia, 117997, Moscow, Russia
| | - O V Britanova
- Pirogov Russian National Research Medical University, Ministry of Health of Russia, 117997, Moscow, Russia
| | - M A Korolev
- Federal Research Center Institute of Cytology and Genetics, Siberian Branch, Russian Academy of Sciences, 630117, Novosibirsk, Russia
| | - D I Abdulganieva
- Kazan State Medical University", Ministry of Health of Russia, 420012, Kazan, Russia
- Pediatric Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan, 420064, Kazan, Russia
| | - D G Krechikova
- Clinical Hospital RZhD-Medicine, Ministry of Health of Russia, 214025, Smolensk, Russia
| | - A A Kastanayan
- Rostov State Medical University, Ministry of Health of Russia, 344022, Rostov-on-Don, Russia
| | - L V Eliseeva
- Siberian State Medical University, Ministry of Health of Russia, 634050, Tomsk, Russia
| | - R R Samigullina
- Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia, 119991, Moscow, Russia
| | - T V Povarova
- Clinical Hospital RZhD-Medicine in Saratov, 410004, Saratov, Russia
| | - O V Antipova
- Irkutsk Municipal Clinical Hospital No. 1, 664046, Irkutsk, Russia
| | - S A Smakotina
- Belyaev Kuzbass Regional Clinical Hospital, 650066, Kemerovo, Russia
- Kemerovo State Medical University, Ministry of Health of Russia, 650056, Kemerovo, Russia
| | - V N Soboleva
- Filatov Municipal Clinical Hospital No. 15, Moscow City Healthcare Department, 111539, Moscow, Russia
| | - O B Nesmeyanova
- Chelyabinsk Regional Clinical Hospital, 454048, Chelyabinsk, Russia
| | - T V Plaksina
- Semashko Nizhny Novgorod Regional Clinical Hospital, 603126, Nizhny Novgorod, Russia
| | - N F Soroka
- Belarusian State Medical University, 220116, Minsk, Republic of Belarus
| | - I B Vinogradova
- Ulyanovsk Regional Clinical Hospital, 432063, Ulyanovsk, Russia
| | - A P Rebrov
- Regional Clinical Hospital, 410053, Saratov, Russia
| | | | - A L Maslyansky
- Almazov National Medical Research Center, Ministry of Health of Russia, 197341, St. Petersburg, Russia
| | | | - Yu N Linkova
- JSC BIOCAD, Strelna Settlements, 198515, St. Petersburg, Russia
| | - P S Pukhtinskaya
- JSC BIOCAD, Strelna Settlements, 198515, St. Petersburg, Russia.
| | - M A Morozova
- JSC BIOCAD, Strelna Settlements, 198515, St. Petersburg, Russia
| | - G A Vinderskaya
- JSC BIOCAD, Strelna Settlements, 198515, St. Petersburg, Russia
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Kong N, Hu J, Liu D, Li J, Wu H, Sun L, Lie D, Tan C, Li Z, Xiao Z, Huang C, Xu J, Yan Y, Li H, Zou H. Efficacy of Ixekizumab in Chinese Patients with Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Level. Rheumatol Ther 2025:10.1007/s40744-025-00765-7. [PMID: 40343690 DOI: 10.1007/s40744-025-00765-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/19/2024] [Accepted: 04/09/2025] [Indexed: 05/11/2025] Open
Abstract
INTRODUCTION Ixekizumab, an interleukin 17A inhibitor, improved the Assessment of SpondyloArthritis international Society 40 (ASAS40) response rates irrespective of baseline inflammation in international populations with radiographic axial spondyloarthritis (r-axSpA). We investigated the association of baseline inflammation (measured by serum C-reactive protein [CRP] levels) with ixekizumab efficacy in Chinese patients with r-axSpA. METHODS This was a subgroup analysis of a Chinese phase 3 study. Adults with r-axSpA who were biologic-naïve, or tumor necrosis factor inhibitor-experienced with baseline CRP > 5 mg/l, were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W) or placebo, for 16 weeks. The following endpoints were analyzed by normal (≤ 5 mg/l) or elevated (> 5 mg/l) baseline CRP levels: ASAS40; Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50); Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1; ASDAS clinically important improvement (CII; change from baseline ≥ 1.1); ASDAS major improvement (MI; change from baseline ≥ 2.0 or achievement of lowest possible score); Bath Ankylosing Spondylitis Metrology Index (BASMI) linear score; Bath Ankylosing Spondylitis Functional Index (BASFI); Short Form-36 Physical Component Score (SF-36 PCS). RESULTS A total of 147 patients were randomized. At week 16, the ASAS40 response rate was greater with IXEQ4W versus placebo in the normal (50.0% vs. 15.0%; p < 0.05) and elevated (29.5% vs. 5.7%; p < 0.01) CRP subgroups. Significant improvements in BASDAI50 response rate, ASDAS < 2.1, and ASDAS CII with IXEQ4W versus placebo were observed in both subgroups (normal CRP: p < 0.05, p < 0.01, and p < 0.05, respectively; elevated CRP: p < 0.01, p < 0.001, and p < 0.001, respectively); IXEQ4W significantly improved ASDAS MI in the elevated CRP subgroup (p < 0.001). IXEQ4W significantly improved linear BASMI and BASFI scores in the normal CRP subgroup (p < 0.001 and p < 0.01, respectively), while SF-36 PCS improved in both subgroups (both p < 0.05). CONCLUSIONS Ixekizumab showed efficacy in Chinese patients with r-axSpA, irrespective of baseline CRP levels, consistent with results in international populations with r-axSpA. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT04285229.
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Affiliation(s)
- Ning Kong
- Department of Rheumatology, Huashan Hospital Affiliated to Fudan University, No. 12 Urumqi Middle Road, Jing'an District, Shanghai, 2000400, China
| | - Jiankang Hu
- Department of Rheumatology, Pingxiang People's Hospital, Pingxiang, Jiangxi, China
| | - Dongzhou Liu
- Department of Rheumatology, Shenzhen People's Hospital, The Second Clinical Medical College of Jinan University, Shenzhen, China
| | - Jingyang Li
- Department of Rheumatology, The Affiliated Zhuzhou Hospital Xiangya Medical College Central South University, Zhuzhou, Hunan, China
| | - Huaxiang Wu
- Department of Rheumatology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
| | - Lingyun Sun
- Department of Rheumatology, Nanjing Drum Tower Hospital, , The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China
| | - Dai Lie
- Department of Rheumatology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
| | - Chunyu Tan
- Department of Rheumatology, West China Hospital of Sichuan University, Chengdu, Sichuan, China
| | - Zhijun Li
- Department of Rheumatology, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China
| | - Zhengyu Xiao
- Department of Rheumatology, The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, China
| | - Cibo Huang
- Department of Rheumatology, South China Hospital of Shenzhen University, Shenzhen, China
- Beijing Hospital, Beijing, China
| | - Jian Xu
- Department of Rheumatology, First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
| | - Yan Yan
- Eli Lilly and Company, Shanghai, China
| | | | - Hejian Zou
- Department of Rheumatology, Huashan Hospital Affiliated to Fudan University, No. 12 Urumqi Middle Road, Jing'an District, Shanghai, 2000400, China.
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Chan ATY. Assessing Disease Activity in Axial Spondyloarthritis: Finding the Balance Between the Bath Ankylosing Spondylitis Disease Activity Index and Axial Spondyloarthritis Disease Activity Score. J Rheumatol 2025; 52:408-411. [PMID: 40169208 DOI: 10.3899/jrheum.2025-0258] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/03/2025]
Affiliation(s)
- Antoni T Y Chan
- A.T.Y. Chan, MD, PhD, University Department of Rheumatology, Royal Berkshire NHS Foundation Trust, Reading, UK.
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12
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Erol K, Akyildiz Tezcan E, Erol S. Piriformis muscle abnormalities in sacroiliac MRI of patients with axial spondyloarthritis. Acta Radiol 2025; 66:521-528. [PMID: 39849943 DOI: 10.1177/02841851241313022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/25/2025]
Abstract
BackgroundPiriformis syndrome, an often-overlooked cause of sciatica, commonly presents as chronic gluteal pain and poses a diagnostic challenge, particularly in patients with axial spondyloarthritis (axSpA).PurposeTo examine piriformis muscle abnormalities on sacroiliac magnetic resonance imaging (MRI) and their association with clinical outcomes in patients with axSpA.Material and MethodsThis cross-sectional study included 100 axSpA patients (50 radiographic [r-axSpA], 50 non-radiographic [nr-axSpA]), classified by the 2009 ASAS Axial Spondyloarthritis criteria, who underwent MRI evaluations of the sacroiliac joints over a 6-month period. Piriformis evaluation included the measurement of muscle size, signal intensity, and the assessment of fatty infiltration. Sciatic neuritis was assessed by identifying enlarged sciatic nerves or increased signal intensity. Data collection included demographic details, disease activity, and functionality parameters. Statistical analysis was performed using appropriate methods, with P < 0.05 indicating significance.ResultsPiriformis syndrome findings were identified in 10% of patients, with a slightly higher incidence in r-axSpA patients (12%) compared to nr-axSpA patients (8%); however, this difference was not statistically significant (P = 0.739). Patients with these MRI findings had significantly higher disease activity, as indicated by the Ankylosing Spondylitis Disease Activity Score with C-reactive protein (3.5 vs. 2.82; P = 0.015), and greater functional impairment, measured by the Bath Ankylosing Spondylitis Functional Index (5.45 vs. 2.7; P = 0.041).ConclusionThis study highlights the presence of MRI findings associated with piriformis syndrome among axSpA patients, which are linked to increased disease activity and reduced function. Recognizing piriformis syndrome as a co-morbidity may improve diagnosis and treatment, leading to better patient outcomes.
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Affiliation(s)
- Kemal Erol
- Department of Physical Medicine and Rehabilitation, Division of Rheumatology, Selcuk University Medical Faculty, Konya, Turkey
| | - Ezgi Akyildiz Tezcan
- Department of Physical Medicine and Rehabilitation, Konya Numune State Hospital, Konya, Turkey
| | - Seyit Erol
- Department of Radiology, Selcuk University Medical Faculty, Konya, Turkey
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13
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Lukina GV, Knyazev OV, Belousova EA, Abdulganieva DI, Aleksandrova EN, Bakulin IG, Barysheva OI, Borisova MА, Vykova BА, Godzenko AА, Gubonina IV, Dubinina TV, Zhigalova TN, Zhilyaev EV, Kagramanova AV, Korotaeva TV, Kuzin AV, Livzan MA, Lila AM, Mazurov VI, Nasonov EL, Novikov AA, Osipenko MF, Parfenov AI, Tarasova LV, Khlynova OV, Shapina MV, Shchukina OB, Erdes SF, Iakovlev AA. [Russian Cross-disciplinary Consensus on the diagnosis and treatment of spondyloarthritis associated with inflammatory bowel diseases]. TERAPEVT ARKH 2025; 97:198-213. [PMID: 40237758 DOI: 10.26442/00403660.2025.02.203117] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/22/2025] [Accepted: 02/22/2025] [Indexed: 04/18/2025]
Abstract
The Russian Cross-disciplinary Consensus on the diagnositic and treatment of spondyloarthritis (SpA) in inflammatory bowel diseases (IBD) was prepared on the initiative of the Loginov Moscow Clinical Scientific Center, using the Delphic system. Its purpose was to consolidate the opinions of experts on the most actual issues of diagnosis and treatment of concomitant immuno-inflammatory diseases (SpA and IBD). An interdisciplinary approach is provided by the participation of leading gastroenterologists and rheumatologists. The working group analyzed domestic and foreign publications on the problem of curation of patients with SpA and IBD. There have been 17 statements and 2 treatment algorithms formulated. Statements 1-3 reflect the fundamental principles of management of patients with SpA and IBD. The principles of early diagnosis of SpA and IBD, including the diagnosis of complications of therapy, are described below. Eleven statements are devoted to current methods of treatment, on the basis of which 2 treatment algorithms have been developed. The statements of the Consensus were submitted to the Expert Council for consideration, edits were made, after which an online vote took place. This paper presents current recommendations for the management, diagnosis and treatment of patients with SpA and IBD.
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Affiliation(s)
- G V Lukina
- Loginov Moscow Clinical Scientific Center
- Nasonova Research Institute of Rheumatology
| | | | - E A Belousova
- Vladimirsky Moscow Regional Research Clinical Institute
| | | | | | - I G Bakulin
- Mechnikov North-Western State Medical University
| | | | | | - B А Vykova
- Ryzikh National Medical Research Centre for Coloproctology
| | - A А Godzenko
- Russian Medical Academy of Continuous Professional Education
| | - I V Gubonina
- Scandinavia Multidisciplinary Clinic (AVA-PETER LLC)
| | | | | | - E V Zhilyaev
- Russian Medical Academy of Continuous Professional Education
- European Medical Center JSC
- Pirogov Russian National Research Medical University (Pirogov University)
| | | | | | - A V Kuzin
- Russian Medical Academy of Continuous Professional Education
| | | | - A M Lila
- Nasonova Research Institute of Rheumatology
| | - V I Mazurov
- Mechnikov North-Western State Medical University
| | | | - A A Novikov
- Loginov Moscow Clinical Scientific Center
- Pirogov Russian National Research Medical University (Pirogov University)
| | | | | | - L V Tarasova
- Ulyanov Chuvash State University
- Republican Clinical Hospital
| | - O V Khlynova
- Academician Vagner Perm State Medical University
| | - M V Shapina
- Ryzikh National Medical Research Centre for Coloproctology
| | - O B Shchukina
- Pavlov First Saint Petersburg State Medical University
| | - S F Erdes
- Nasonova Research Institute of Rheumatology
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Berbel-Arcobé L, Benavent D, Valencia-Muntalà L, Gómez-Vaquero C, Juanola X, Nolla JM. Assessing Sarcopenia, Presarcopenia, and Malnutrition in Axial Spondyloarthritis: Insights from a Spanish Cohort. Nutrients 2025; 17:1019. [PMID: 40290081 PMCID: PMC11944953 DOI: 10.3390/nu17061019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/23/2025] [Revised: 03/11/2025] [Accepted: 03/12/2025] [Indexed: 04/30/2025] Open
Abstract
BACKGROUND/OBJECTIVES Sarcopenia, defined by a loss of muscle mass, strength, and function, is a potential comorbidity in axial spondyloarthritis (axSpA). Its prevalence, along with malnutrition, remains unclear. METHODS This cross-sectional study assessed sarcopenia (using the European Working Group on Sarcopenia in Older People (EWGSOP-2) criteria), presarcopenia, and malnutrition (using the Global Leadership Initiative on Malnutrition (GLIM) criteria) in a Spanish axSpA cohort. We included 94 patients aged ≥ 50 years. Sarcopenia was evaluated using the SARC-F questionnaire and by measuring muscle strength, mass, and performance. Presarcopenia was defined as low muscle mass alone. Malnutrition was assessed using body mass index (BMI) and fat-free mass index (FFMI). RESULTS The prevalence of sarcopenia, presarcopenia, and malnutrition was 3.2%, 23.4%, and 10.6%, respectively. Sarcopenia correlated with worse functionality and quality of life (Bath Ankylosing Spondylitis Functional Index (BASFI) 7.6 ± 1.2 vs. 3.6 ± 2.5, p = 0.02; ASAS Health Index (ASAS-HI) 11 ± 2 vs. 5.6 ± 3.7, p = 0.03). Presarcopenia was linked to a lower BMI (24.7 ± 4.1 vs. 29.1 ± 4.2, p < 0.01), FFMI (16.1 ± 2 vs. 19.6 ± 2.6, p < 0.01), and reduced biologic treatment use (31.8% vs. 61.1%, p = 0.03). Malnourished patients had lower muscle mass (5.14 ± 0.73 vs. 6.23 ± 0.96, p < 0.01). SARC-F showed 100% sensitivity and 75.8% specificity for sarcopenia detection. CONCLUSIONS Despite low sarcopenia prevalence, presarcopenia and malnutrition are frequent, highlighting the need for early detection in axSpA.
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Affiliation(s)
- Laura Berbel-Arcobé
- Rheumatology Department, Hospital Universitari de Bellvitge-IDIBELL, Carrer de la Feixa Llarga S/N, L’Hospitalet de Llobregat, 08907 Barcelona, Spain
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15
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Yang K, Gong Y, Xu X, Sun T, Qu X, He X, Liu H. Prediction model for psychological disorders in ankylosing spondylitis patients based on multi-label classification. Front Public Health 2025; 13:1497955. [PMID: 40104117 PMCID: PMC11913693 DOI: 10.3389/fpubh.2025.1497955] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/18/2024] [Accepted: 02/06/2025] [Indexed: 03/20/2025] Open
Abstract
Objective This study aims to develop a predictive model to assess the likelihood of psychological disorders in patients with ankylosing spondylitis (AS) and to explore the relationships between different factors and psychological disorders. Methods Patients were randomly divided into training and test sets in an 8:2 ratio. The Boruta algorithm was applied to select predictive factors, and a multi-label classification learning algorithm based on association rules (AR) was developed. Models were constructed using Random Forest (RF), K-Nearest Neighbor (KNN), RF-AR, and KNN-AR, and their performance was assessed through receiver operating characteristic (ROC) curves on the test set. Results A total of 513 AS patients were included, with 410 in the training set and 103 in the test set. The Boruta algorithm identified five key variables for the model: fatigue, ASAS-HI score, disease duration, disease activity, and BMI. The RF-AR model performed best, with an accuracy of 0.89 ± 0.06, recall of 0.78 ± 0.1, F1-score of 0.86 ± 0.08, Hamming loss of 0.05 ± 0.03, and a Jaccard similarity coefficient of 0.75 ± 0.12. The area under the curve (AUC) for the training set was 0.94. Conclusion This study developed a predictive model for assessing the risk of psychological disorders in AS patients. The model effectively captures the presence of psychological disorders, providing clinicians with valuable insights for adjusting treatment strategies.
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Affiliation(s)
- Kun Yang
- Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
| | - Yifan Gong
- Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
| | - Xiaohan Xu
- Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
| | - Tiantian Sun
- Graduate School of Beijing University of Chinese Medicine, Beijing, China
| | - Xinning Qu
- Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
| | - Xiaxiu He
- Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
| | - Hongxiao Liu
- Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
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Schmukler J, Li T, Block JA, Pincus T. RheuMetric Physician 0 to 10 Estimates of Inflammation, Damage, and Patient Distress at Initial Versus Follow-Up Visits in Contemporary Rheumatology Care. ACR Open Rheumatol 2025; 7:e70010. [PMID: 40035323 PMCID: PMC11877136 DOI: 10.1002/acr2.70010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/31/2024] [Revised: 12/19/2024] [Accepted: 01/10/2025] [Indexed: 03/05/2025] Open
Abstract
OBJECTIVE We aimed to analyze the RheuMetric physician 0 to 10 visual numeric subscale (VNS) estimates of inflammatory activity (DOCINF), organ damage (DOCDAM), and patient distress (DOCDIS) at initial and follow-up routine rheumatology visits for possible incremental information to clarify physician estimate of global assessment (DOCGL). METHODS A retrospective cross-sectional study compared mean DOCGL, DOCINF, DOCDAM, and DOCDIS and the percentage contributed by inflammation, damage, and distress to DOCGL (total = 100%) at initial and follow-up visits in 563 unselected routine care patients, classified into four diagnosis categories: inflammatory (rheumatoid arthritis, systemic lupus erythematosus [SLE], spondylarthritis, vasculitis, and gout), primary osteoarthritis (OA), primary fibromyalgia (FM), and "other" diagnoses. Differences between initial and follow-up visits were estimated using t-tests. RESULTS In all patients, mean DOCGL was 4.0/10, DOCINF 1.6/10, DOCDAM 2.9/10, and DOCDIS 2.4/10, indicating higher estimates for damage and distress than for inflammation, including in all inflammatory diagnoses other than SLE. Highest mean estimates were 2.2 for DOCINF in inflammatory diagnoses, 4.9 for DOCDAM in primary OA, 6.3 for DOCDIS in primary FM. However, DOCDAM was 2.8 (0.6 uniyts higher than DOCINF) in inflammatory diagnoses. RheuMetric estimates of inflammation were significantly higher at initial than at follow-up visits, and estimates of damage were significantly lower at initial than at follow-up visits in all patients and in those with inflammatory diagnoses. DOCGL did not differ significantly at initial versus follow-up visits. CONCLUSION DOCINF, DOCDAM, and DOCDIS add feasibly recorded, clinically relevant incremental information to DOCGL. Despite excellent contemporary control of inflammation, joint damage and patient distress remain important clinical problems in contemporary routine rheumatology care, documented by quantitative RheuMetric estimates.
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Affiliation(s)
| | - Tengfei Li
- Rush University Medical CenterChicagoIllinois
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Demirulus S, Kilic G, Karkucak M, Capkin E. Exploring Exercise Perceptions and Physical Activity Levels in Radiographic and Non-Radiographic Axial Spondyloarthritis: A Comparative Study. Musculoskeletal Care 2025; 23:e70081. [PMID: 40119881 DOI: 10.1002/msc.70081] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/18/2025] [Revised: 03/05/2025] [Accepted: 03/07/2025] [Indexed: 03/25/2025]
Abstract
AIM This study aims to compare physical activity (PA) levels and exercise-related perceptions, including barriers and facilitators, between radiographic axial spondyloarthritis (r-axSpA) and non-radiographic axial spondyloarthritis (nr-axSpA) patients, and to explore the relationships between PA, exercise perceptions and clinical parameters in axSpA patients. METHODS A cross-sectional design was used to recruit 123 axSpA patients, comprising 83 r-axSpA and 40 nr-axSpA. Clinical parameters, including disease activity, pain, spinal mobility, enthesopathy, physical function, fatigue, sleep quality, quality of life, fibromyalgia symptoms, kinesiophobia, and mental health, were assessed. PA levels were measured using the International Physical Activity Questionnaire-Short Form, while exercise perception was evaluated using the Exercise Benefits/Barriers Scale. Multivariable regressions examined the relationships between PA, exercise perception, and clinical variables. RESULTS Physical activity levels were comparable between subgroups (p = 0.654), but r-axSpA patients reported significantly higher exercise barriers (p = 0.023). In the r-axSpA group, the most commonly endorsed benefit was "Exercise improves my flexibility" (94%), while in the nr-axSpA group, it was "Exercise increases my physical fitness" (95%). In both groups, the most common barrier was "Exercise tires me". Higher PA was linked to improved physical function and reduced kinesiophobia in nr-axSpA, and lower anxiety in r-axSpA (p < 0.05). Regression analysis revealed that PA level was related to symptom duration and enthesopathy, while exercise benefits were associated with health status, depression, physical function, and barriers with fatigue in axSpA patients. CONCLUSION Tailored interventions are essential to promote exercise participation in axSpA patients by addressing subgroup-specific barriers and clinical factors.
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Affiliation(s)
- Serpil Demirulus
- Division of Rheumatology, Department of Physical Medicine and Rehabilitation, Karadeniz Technical University School of Medicine, Trabzon, Turkey
| | - Gamze Kilic
- Division of Rheumatology, Department of Physical Medicine and Rehabilitation, Karadeniz Technical University School of Medicine, Trabzon, Turkey
| | - Murat Karkucak
- Division of Rheumatology, Department of Physical Medicine and Rehabilitation, Karadeniz Technical University School of Medicine, Trabzon, Turkey
| | - Erhan Capkin
- Division of Rheumatology, Department of Physical Medicine and Rehabilitation, Karadeniz Technical University School of Medicine, Trabzon, Turkey
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van der Heijde D, Navarro-Compán V, Landewé R, Sieper J, van Gaalen F, Gensler LS, Machado PM, Marzo-Ortega H, Poddubnyy D, Protopopov M, Ramiro S, Sepriano A, Baraliakos X. 1995-2025: thirty years of ASAS and its contribution to the understanding of spondyloarthritis. Ann Rheum Dis 2025; 84:382-387. [PMID: 39948004 DOI: 10.1016/j.ard.2025.01.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/16/2024] [Revised: 12/17/2024] [Accepted: 12/18/2024] [Indexed: 03/03/2025]
Abstract
OBJECTIVE To describe the role of the Assessment of SpondyloArthritis interntational Society (ASAS) over the past 30 years in the understanding of the field of spondyloarthritis. METHODS A narrative review of the achievements. RESULTS A summary of the role of ASAS in defining nomenclature, definition of and criteria for SpA, outcome assessments, recommendations, and education. CONCLUSION ASAS played an important role in shaping the field of SpA.
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Affiliation(s)
| | | | - Robert Landewé
- Department of rheumatology and clinical immunology, Amsterdam University Medical Center, Amsterdam, The Netherlands; Department of Rheumatology, Zuyderland Medical Center, Heerlen, The Netherlands
| | | | - Floris van Gaalen
- Department of Rheumatology, Leiden University, Leiden, the Netherlands
| | - Lianne S Gensler
- Division of Rheumatology, University of California San Francisco, San Francisco, CA, USA
| | - Pedro M Machado
- Department of Neuromuscular Diseases, UCL Queen Square Institute of Neurology, University College London, London, UK; Department of Rheumatology, Division of Medicine, University College London, London, UK; NIHR University College London Hospitals Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK
| | - Helena Marzo-Ortega
- NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK
| | - Denis Poddubnyy
- Division of Rheumatology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada; Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Mikhail Protopopov
- Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany
| | - Sofia Ramiro
- Department of Rheumatology, Leiden University, Leiden, the Netherlands; Department of Rheumatology, Zuyderland Medical Center, Heerlen, The Netherlands
| | - Alexandre Sepriano
- Department of Rheumatology, Leiden University, Leiden, the Netherlands; NOVA Medical School, UNL, Lisbon, Portugal
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Polysopoulos C, Georgiadis S, Ørnbjerg LM, Scherer A, Di Giuseppe D, Hetland ML, Nissen MJ, Jones GT, Glintborg B, Loft AG, Wallman JK, Pavelka K, Závada J, Yazici A, Santos MJ, Ciurea A, Möller B, Michelsen B, Mielnik P, Huhtakangas J, Relas H, Pirkmajer KP, Rotar Z, MacDonald R, Gudbjornsson B, van der Horst-Bruinsma I, van de Sande M, Riek M. Handling of missing component information for common composite score outcomes used in axial spondyloarthritis research when complete-case analysis is unbiased. BMC Med Res Methodol 2025; 25:55. [PMID: 40021967 PMCID: PMC11869558 DOI: 10.1186/s12874-025-02515-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/28/2023] [Accepted: 02/19/2025] [Indexed: 03/03/2025] Open
Abstract
BACKGROUND Observational data on composite scores often comes with missing component information. When a complete-case (CC) analysis of composite scores is unbiased, preferable approaches of dealing with missing component information should also be unbiased and provide a more precise estimate. We assessed the performance of several methods compared to CC analysis in estimating the means of common composite scores used in axial spondyloarthritis research. METHODS Individual mean imputation (IMI), the modified formula method (MF), overall mean imputation (OMI), and multiple imputation of missing component values (MI) were assessed either analytically or by means of simulations from available data collected across Europe. Their performance in estimating the means of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), and the Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP) in cases where component information was set missing completely at random was compared to the CC approach based on bias, variance, and coverage. RESULTS Like the MF method, IMI uses a modified formula for observations with missing components resulting in modified composite scores. In the case of an unbiased CC approach, these two methods yielded representative samples of the distribution arising from a mixture of the original and modified composite scores, which, however, could not be considered the same as the distribution of the original score. The IMI and MF method are, thus, intrinsically biased. OMI provided an unbiased mean but displayed a complex dependence structure among observations that, if not accounted for, resulted in severe coverage issues. MI improved precision compared to CC and gave unbiased means and proper coverage as long as the extent of missingness was not too large. CONCLUSIONS MI of missing component values was the only method found successful in retaining CC's unbiasedness and in providing increased precision for estimating the means of BASDAI, BASFI, and ASDAS-CRP. However, since MI is susceptible to incorrect implementation and its performance may become questionable with increasing missingness, we consider the implementation of an error-free CC approach a valid and valuable option. TRIAL REGISTRATION Not applicable as study uses data from patient registries.
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Affiliation(s)
- Christos Polysopoulos
- Statistics Group, Swiss Clinical Quality Management (SCQM) Foundation, Aargauerstrasse 250, Zurich, 8048, Switzerland
| | - Stylianos Georgiadis
- Copenhagen Centre for Arthritis Research (COPECARE), Centre for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark
| | - Lykke Midtbøll Ørnbjerg
- Copenhagen Centre for Arthritis Research (COPECARE), Centre for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark
| | - Almut Scherer
- Statistics Group, Swiss Clinical Quality Management (SCQM) Foundation, Aargauerstrasse 250, Zurich, 8048, Switzerland
| | - Daniela Di Giuseppe
- Department of Medicine Solna, Clinical Epidemiology Division, Karolinska Institutet, Stockholm, Sweden
| | - Merete Lund Hetland
- Copenhagen Centre for Arthritis Research (COPECARE) and the DANBIO Registry, Centre for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark
| | | | - Gareth T Jones
- Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen, UK
| | - Bente Glintborg
- Copenhagen Centre for Arthritis Research (COPECARE) and the DANBIO Registry, Centre for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark
| | - Anne Gitte Loft
- Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark
| | - Johan Karlsson Wallman
- Department of Clinical Sciences Lund, Rheumatology, Skåne University Hospital, Lund University, Lund, Sweden
| | | | - Jakub Závada
- Institute of Rheumatology, Prague, Czech Republic
| | - Ayten Yazici
- Division of Rheumatology, Department of Internal Medicine, School of Medicine, Kocaeli University, Kocaeli, Turkey
| | | | - Adrian Ciurea
- Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland
| | - Burkhard Möller
- Department Rheumatology and Immunology, Inselspital - University Hospital Bern, Bern, Switzerland
| | - Brigitte Michelsen
- Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
| | - Pawel Mielnik
- Section for Rheumatology, Department for Neurology, Rheumatology and Physical Medicine, Helse Førde, Førde, Norway
| | | | - Heikki Relas
- Rheumatology, Inflammation Center, Helsinki University Hospital and University of Helsink, Helsinki, Finland
| | | | - Ziga Rotar
- Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Ross MacDonald
- Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen, UK
| | - Bjorn Gudbjornsson
- Faculty of Medicine, University of Iceland, Reykjavik, Iceland
- Centre for Rheumatology Research, Landspitali University Hospital, Reykjavik, Iceland
| | | | - Marleen van de Sande
- Amsterdam UMC, Department of Rheumatology & Clinical Immunology and Department of Experimental Immunology, Amsterdam Institute for Infection & Immunity, University of Amsterdam, Amsterdam, The Netherlands
| | - Myriam Riek
- Statistics Group, Swiss Clinical Quality Management (SCQM) Foundation, Aargauerstrasse 250, Zurich, 8048, Switzerland.
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20
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Aleixo CD, Ziegeler K, Ulas ST, Diekhoff T, Greese J, Lindholz M, Rademacher J, Rios Rodriguez V, Poddubnyy D, Proft F. Influence of sacroiliac joint variation on clinical features of axial spondyloarthritis: a comparative analysis. RMD Open 2025; 11:e004923. [PMID: 39922705 PMCID: PMC11808880 DOI: 10.1136/rmdopen-2024-004923] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/02/2024] [Accepted: 01/28/2025] [Indexed: 02/10/2025] Open
Abstract
OBJECTIVES Anatomical variation of the sacroiliac (SI) joints is common and specific variants are associated with erosions and bone marrow oedema on imaging. Our investigation aims to evaluate whether anatomical variations influence the clinical presentation of axial spondyloarthritis (axSpA). METHODS In this propensity score matched post hoc analysis documented clinical data from four prospective clinical cohorts was assessed. Classification of back pain as inflammatory (=IBP), human leucocyte antigen-B27 positivity, family history, disease activity according to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), symptom duration, elevated acute phase reactants, peripheral and extramusculoskeletal manifestations were evaluated. Statistical analyses were done using (generalised) linear models, t-tests, χ2 tests and analysis of variances. Multiple testing was corrected according to Bonferroni. RESULTS A total of 165 patients (86 women) were included. Atypical SI joints, defined by the presence of accessory joint facets, iliosacral complex or crescent-shaped ilii on MRI, were identified in 61 out of 165 patients with axSpA. Disease activity, assessed by BASDAI and symptom duration were similar in both groups (adjusted ß=-0.118 (95% CI -0.713, 0.476), p=0.696 and 120.0 (107.4) vs 116.5 (98.3) months, p=0.838, respectively). There was no significant difference in IBP between the groups (adjusted OR=0.614 (95% CI 0.274, 1.377), p=0.236). Sex-stratified analysis revealed no statistically significant results. CONCLUSION Our analysis suggests that clinical phenotypes do not significantly differ between patients with axSpA with and without atypical joints.
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Affiliation(s)
| | - Katharina Ziegeler
- Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, California, USA
| | - Sevtap Tugce Ulas
- Department of Radiology, Charité University Hospital Berlin, Berlin, Germany
| | - Torsten Diekhoff
- Department of Radiology, Charité University Hospital Berlin, Berlin, Germany
| | - Juliane Greese
- Department of Radiology, Charité University Hospital Berlin, Berlin, Germany
| | - Maximilian Lindholz
- Department of Radiology, Charité University Hospital Berlin, Berlin, Germany
| | - Judith Rademacher
- Department of Gastroenterology, Infectiology and Rheumatology, Charité - Universitätsmedizin Berlin, Berlin, Berlin, Germany
- Berlin Institute of Health at Charité, Berlin, Berlin, Germany
| | - Valeria Rios Rodriguez
- Department of Gastroenterology, Infectiology and Rheumatology, Charité - Universitätsmedizin Berlin, Berlin, Berlin, Germany
| | - Denis Poddubnyy
- Department of Gastroenterology, Infectiology and Rheumatology, Charité - Universitätsmedizin Berlin, Berlin, Berlin, Germany
| | - Fabian Proft
- Department of Gastroenterology, Infectiology and Rheumatology, Charité - Universitätsmedizin Berlin, Berlin, Berlin, Germany
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Hosseini M, Houjaghan AK, Behzad G, Ghorbanpour S, Razavi SZE, Azadvari M, Movaseghi S, Salaminour N. Psychometric Properties of the Persian Version of the Evaluation of Ankylosing Spondylitis Quality of Life (EASi-QoL) and Ankylosing Spondylitis Disease Activity Score (ASDAS) Questionnaires: A Cross-Sectional Study. Health Sci Rep 2025; 8:e70417. [PMID: 39906243 PMCID: PMC11790465 DOI: 10.1002/hsr2.70417] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/24/2023] [Revised: 11/01/2024] [Accepted: 01/10/2025] [Indexed: 02/06/2025] Open
Abstract
Background and Aims Ankylosing spondylitis (AS) is a chronic inflammatory disease that affects quality of life (QoL) due to its impact on physical and emotional well-being. Accurate and reliable tools are needed to assess disease activity and QoL in different cultural contexts. This study aimed to evaluate the psychometric properties of the Persian versions of the Evaluation of Ankylosing Spondylitis Quality of Life (EASi-QoL) and Ankylosing Spondylitis Disease Activity Score (ASDAS) scales in Iranian AS patients. Methods A cross-sectional study was conducted on 70 AS patients referred to a tertiary hospital in Tehran. Patients completed the EASi-QoL, and 39 also completed the ASDAS questionnaire. The translation followed the forward-backward method. Reliability was assessed using Cronbach's α for internal consistency and intraclass correlation coefficient (ICC) for test-retest reliability. Content validity was evaluated using the content validity ratio (CVR) and Content Validity Index (CVI). Test-retest reliability was examined using Spearman's rank correlation for non-normally distributed data. Results The ICC values for EASi-QoL ranged from 0.71 to 0.82, while Spearman's correlation coefficients ranged from 0.63 to 0.80. For ASDAS, all items except Question 1 had ICC and Spearman's correlation coefficients above 0.8, indicating high test-retest reliability. The average CVR for EASi-QoL was 0.56, and for ASDAS it was 0.68. The CVI for relevance, clarity, and simplicity ranged from 0.86 to 0.96 for both scales, confirming good content validity. Conclusion The Persian versions of the EASi-QoL and ASDAS scales demonstrate adequate reliability and validity. These tools are suitable for assessing QoL and disease activity in Iranian AS patients, providing culturally relevant measurements for clinical and research settings.
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Affiliation(s)
- Maryam Hosseini
- Department of Physical Medicine and RehabilitationImam Khomeini Hospital Complex, Tehran University of Medical SciencesTehranIran
| | | | - Ghazal Behzad
- School of MedicineTehran University of Medical SciencesTehranIran
| | - Sahar Ghorbanpour
- Department of Physical Medicine and RehabilitationImam Khomeini Hospital Complex, Tehran University of Medical SciencesTehranIran
| | - Seyede Zahra Emami Razavi
- Department of Physical Medicine and RehabilitationBrain and Spinal Cord Injury Research Center, Neuroscience Institute, Imam Khomeini Hospital Complex, Tehran University of Medical SciencesTehranIran
| | - Mohaddeseh Azadvari
- Department of Physical Medicine and RehabilitationUrology Research Center, Sina and Imam Khomeini Hospital Complex, Tehran University of Medical SciencesTehranIran
| | - Shafieh Movaseghi
- Department of RheumatologyImam Khomeini Hospital Complex, Tehran University of Medical SciencesTehranIran
| | - Negar Salaminour
- School of MedicineTehran University of Medical SciencesTehranIran
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Huang H, Zhuang F, Liu X, Wu K, Wang F, Zhao X, Zhang Y, Cao D. T2* cartilage mapping in early axial spondyloarthritis: diagnostic accuracy and correlation with clinical characteristics, sacroiliitis MRI scorings, and diffusion metrics. Eur Radiol 2025; 35:837-847. [PMID: 39048742 DOI: 10.1007/s00330-024-10975-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2024] [Revised: 05/19/2024] [Accepted: 07/07/2024] [Indexed: 07/27/2024]
Abstract
PURPOSE To determine the performance of T2* cartilage mapping in diagnosing and assessing disease activity in early axial spondyloarthritis (axSpA), and to investigate the interaction of cartilage damage with clinical characteristics, sacroiliitis MRI scorings, and diffusion metrics. MATERIALS AND METHODS This prospective study included 83 axSpA patients and 37 no-axSpA patients. Clinical characteristics, the Assessment of SpondyloArthritis International Society-defined active sacroiliitis on MRI, and T2* SIJs values were recorded. In axSpA, disease activity was evaluated using the ankylosing spondylitis disease activity score-C-reactive protein; active sacroiliitis was evaluated using Spondyloarthritis Research Consortium of Canada, intravoxel incoherent motion, and diffusion kurtosis imaging; chronic sacroiliitis was assessed using composite structural damage score (CSDS) and structural score fat. Mann-Whitney U-test, Kruskal-Wallis test with false discovery rate (FDR), ROC curve, and linear regression were used for statistical analysis. RESULTS AxSpA patients had significantly higher T2*SIJs values than no-axSpA patients. (22.86 ± 2.42 ms vs 20.36 ± 1.30 ms, p < 0.001). The combination of T2*SIJs values and active sacroiliitis on MRI had the highest AUC for identifying axSpA. T2*SIJs values were significantly different between the inactive and very high, moderate and very high, high and very high, as well as inactive and high disease activity groups (all pFDR < 0.05). Dk (β = 0.48) and CSDS (β = 0.48) were independently associated with T2*SIJs values. CONCLUSION T2* values may be a promising biomarker for diagnosing and differentiating disease activity in early axSpA. Both acute and chronic sacroiliitis influence cartilage properties. CLINICAL RELEVANCE STATEMENT Sacroiliac joint cartilage abnormalities can be quantified with T2* relaxation time and allow better characterization of early axSpA. KEY POINTS T2* mapping may have value in evaluating axSpA. The combination of T2* values and active sacroiliitis on MRI enhances diagnostic performance for axSpA. Abnormalities measured with T2* values correlate with disease activity, acute sacroiliitis, and degree of structural damage.
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Affiliation(s)
- Hongjie Huang
- Department of Radiology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China
- Department of Radiology, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital of Fujian Medical University, Fuzhou, China
| | - Feifei Zhuang
- Department of Radiology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China
| | - Xi Liu
- Department of Radiology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China
| | - Keyi Wu
- Department of Radiology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China
| | - Feng Wang
- Department of Radiology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China
| | | | - Yuyang Zhang
- Department of Radiology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.
| | - Dairong Cao
- Department of Radiology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.
- Department of Radiology, National Regional Medical Center, Binhai Campus of the First Affiliated Hospital of Fujian Medical University, Fuzhou, China.
- Department of Radiology, Fujian Key Laboratory of Precision Medicine for Cancer, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.
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23
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Hurtubise R, Rohekar S, Haroon N, Baskurt Z, Chim T, Zummer M, Inman RD, Richard N. Impact of disease manifestations on first biologic drug survival in axial spondyloarthritis: a real-life Canadian study. Rheumatol Adv Pract 2025; 9:rkaf004. [PMID: 39886539 PMCID: PMC11780884 DOI: 10.1093/rap/rkaf004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/08/2024] [Accepted: 12/22/2024] [Indexed: 02/01/2025] Open
Abstract
Objectives The primary objective of this study was to assess the impact of extramusculoskeletal manifestations (EMMs) and peripheral musculoskeletal features on first biologic drug survival in subjects with axial spondyloarthritis (axSpA). The secondary objective was to evaluate the impact of reasons for treatment discontinuation. Methods A total of 593 axSpA patients from the SpondyloArthritis Research Consortium of Canada initiating a first biologic drug were identified between 2003 and 2023. Drug survival was presented using Kaplan-Meier curves for each disease manifestation and compared using the logrank test. A Cox proportional hazards model was used to analyse independent predictors of discontinuation. The impact of reasons for treatment discontinuation was assessed using a competing risk analysis. Results The presence of psoriasis, nail psoriasis, dactylitis, at least one EMM or at least one peripheral musculoskeletal manifestation was associated with prolonged drug survival compared with subjects without these disease manifestations. In multivariable analysis, psoriasis [hazard ratio (HR) 0.53 (95% CI 0.33, 0.86)] and at least one peripheral musculoskeletal manifestation [HR 0.65 (95% CI 0.47, 0.92)] were independently associated with a lower risk for biologic discontinuation. The presence of psoriasis or dactylitis was associated with reduced treatment discontinuation in patients who stopped their biologic medication for ineffectiveness but not when treatment was discontinued due to adverse events. Conclusions This study showed that the presence of some axSpA disease manifestations were associated with prolonged biologic drug survival. Psoriasis and peripheral musculoskeletal manifestations were the most significant predictors of treatment retention. Future research will be needed to further refine treatment strategies according to specific disease manifestations.
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Affiliation(s)
- Raphaël Hurtubise
- Department of Medicine, Université de Montréal, Montreal, QC, Canada
| | - Sherry Rohekar
- Division of Rheumatology, Department of Medicine, Western University, London, ON, Canada
| | - Nigil Haroon
- Division of Rheumatology, University Health Network, Toronto, ON, Canada
| | - Zeynep Baskurt
- Division of Rheumatology, University Health Network, Toronto, ON, Canada
| | - Tina Chim
- Division of Rheumatology, University Health Network, Toronto, ON, Canada
| | - Michel Zummer
- Department of Medicine, Université de Montréal, Montreal, QC, Canada
- Division of Rheumatology, Hôpital Maisonneuve Rosemont, Montreal, QC, Canada
| | - Robert D Inman
- Division of Rheumatology, University Health Network, Toronto, ON, Canada
| | - Nicolas Richard
- Department of Medicine, Université de Montréal, Montreal, QC, Canada
- Division of Rheumatology, Hôpital Maisonneuve Rosemont, Montreal, QC, Canada
- Centre de Recherche de l’Hôpital Maisonneuve-Rosemont, Montreal, QC, Canada
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24
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Machado NP, Pinheiro MM, Chula DC, Ceron R, Pinheiro FI, Serrato VA, Azevedo VF, Moreira CA. Low Bone Turnover, Mineralization Impairment, and Cortical Alterations in Patients with Axial Spondyloarthritis: A Histomorphometric Study. Calcif Tissue Int 2025; 116:17. [PMID: 39751834 DOI: 10.1007/s00223-024-01314-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/29/2024] [Accepted: 11/17/2024] [Indexed: 01/04/2025]
Abstract
Patients with radiographic axial spondyloarthritis (r-axSpA) experience a higher prevalence of fragility fractures, though the pathophysiology of osteoporosis associated with this disease remains poorly understood. The objective of this study was to evaluate the histomorphometric data in r-axSpA patients. Male r-axSpA patients up to 55 years old were enrolled in this cross-sectional study. Clinical, lab, and imaging data, including spine X-Ray to evaluate vertebral fractures and new bone formation, as well as dual-energy X-ray absorptiometry (DXA) at spine, hip, and forearm and trabecular bone score (TBS), were performed in all patients. Transiliac histomorphometry was also underwent in all patients, and data were compared with 21 male cadavers' material. A total of 21 patients were included, with a mean age of 45.8 years, long disease duration (median 17.5 years), mostly white (66.7%) and positive for HLA-B27 (90.5%). The prevalence of DXA abnormalities and low TBS (≤ 1.338) was 42.8% and 57.1%, respectively. There was higher osteoid trabecular thickness (p = 0.027) and cortical bone changes, including reduced thickness (p = 0.031) and increased porosity (p = 0.015) in r-axSpA patients. In addition, a pattern of cortical trabecularization was observed in 52.3%. Dynamic evaluation revealed a longer mineralization lag time (p = 0.0074) and lower mineralized surface (p = 0.0029) and bone formation rate (p = 0.0074) in patients compared to reference values. Our results showed a pattern of low trabecular remodeling, bone mineralization impairment, as well as cortical thickness and porosity abnormalities in men with r-axSpA. These findings may impact future treatment of bone fragility in this disease.
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Affiliation(s)
- Natalia P Machado
- Rheumatology Division, Federal University of Parana (UFPR), Paulo Graeser Sobrinho Street 792, House 3, ZIP Code 80510372, Curitiba, PR, Brazil.
| | - Marcelo M Pinheiro
- Rheumatology Division, Federal University of São Paulo (UNIFESP/ EPM), São Paulo, SP, Brazil
| | - Domingos C Chula
- Nephrology Division, Federal University of Parana (UFPR), Curitiba, PR, Brazil
| | - Rafaela Ceron
- Federal University of Parana (UFPR), Curitiba, PR, Brazil
| | - Francisco I Pinheiro
- Ophthalmological Department, Federal University of Rio Grande do Norte (UFRN) and Biotechnology Division, Potiguar University (UnP), Natal, RN, Brazil
| | - Varlei A Serrato
- Ophthalmological Department, Federal University of Rio Grande do Norte (UFRN) and Biotechnology Division, Potiguar University (UnP), Natal, RN, Brazil
| | - Valderílio F Azevedo
- Rheumatology Division, Federal University of Parana (UFPR), Paulo Graeser Sobrinho Street 792, House 3, ZIP Code 80510372, Curitiba, PR, Brazil
| | - Carolina A Moreira
- Internal Medicine Division, Federal University of Parana (UFPR), Curitiba, PR, Brazil
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Kang KY, Park SY, Chung TH. Long-term association between physical activity and global functioning in patients with axial spondyloarthritis: results of a two-year prospective study. Scand J Rheumatol 2025; 54:8-15. [PMID: 39045679 DOI: 10.1080/03009742.2024.2376810] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/15/2024] [Accepted: 07/03/2024] [Indexed: 07/25/2024]
Abstract
OBJECTIVES To assess the longitudinal association between physical activity and global functioning in patients with axial spondyloarthritis (axSpA), and to identify the subtype of physical activity that is longitudinally related to global functioning. METHOD Physical activity was measured using Global Physical Activity Questionnaire. Global functioning was assessed using the Assessment of SpondyloArthritis international Society Health Index (ASAS HI). The amount and subtype (work, transport, and recreation) of physical activity, disease activity, and ASAS HI were assessed at baseline, and at 1 and 2 year follow-up. Physical activity levels were categorized as low, moderate, or high. The longitudinal association between physical activity and ASAS HI scores was analysed using a generalized estimating equation. RESULTS The study evaluated 160 patients. Univariate analysis identified physical activity at moderate level and higher, Ankylosing Spondylitis Disease Activity Score (ASDAS), and syndesmophyte number as being longitudinally associated with ASAS HI over 2 years. Multivariate analysis identified physical activity at moderate level and higher as being longitudinally associated with ASAS HI. Physical activity above moderate levels was associated independently with good global functioning. In the analysis stratified by radiographic axSpA and non-radiographic axSpA, a positive association between physical activity and global functioning was observed in both groups. Only recreational activity, but not work- and transport-related activity, showed an independent longitudinal relationship with the ASAS HI score. CONCLUSIONS Physical activity at moderate level and higher was associated independently with global functioning in axSpA. Therefore, patients should maintain physical activity above moderate levels to preserve global function.
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Affiliation(s)
- K Y Kang
- Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, MD, USA
- Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
| | - S Y Park
- Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
| | - T H Chung
- Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, MD, USA
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Gendron E, Maguire S, Anderson M, Johnson SR, Inman RD, Haroon N. The effect of alcohol consumption on clinical outcomes and structural damage in patients with axial spondyloarthritis: A systematic literature review and meta-analysis. Joint Bone Spine 2025; 92:105794. [PMID: 39461411 DOI: 10.1016/j.jbspin.2024.105794] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/21/2024] [Revised: 08/27/2024] [Accepted: 09/25/2024] [Indexed: 10/29/2024]
Abstract
OBJECTIVE To systematically review the effects of alcohol consumption (AC) on disease-specific outcomes in axial spondyloarthritis (axSpA). METHODS A systematic review of observational studies on axSpA and AC was conducted. Multiple electronic databases were searched for keywords. Two investigators reviewed articles to assess for inclusion eligibility. The Joanna Briggs Institute Critical Appraisal checklist was employed to evaluate the risk of bias. Standardized mean differences (SMD) were used to synthesize the data and I2 was used to ascertain heterogeneity. Spinal pain, disease activity as measured by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS), and spinal radiographic progression based on the modified Stokes Ankylosing Spondylitis Spinal Score (mSASSS) were examined as outcomes. RESULTS Search strategy identified 703 records; 13 articles were assessed for eligibility. Five studies (n=3858) were included. Compared to non-consumers, axSpA patients who consumed alcohol had lower BASDAI (SMD: -0.19, 95% CI: -0.37 to -0.02, I2=72.5%) and lower spinal pain (SMD: -0.17, 95% CI: -0.24 to -0.09, I2=0%). No significant difference was found for ASDAS (SMD: -0.19, 95% CI: -0.39 to 0.00, I2=36%). One cohort study on the spinal radiographic progression indicated greater radiographic progression among consumers (SMD: 0.35, 95% CI: 0.08 to 0.62). CONCLUSION AC appears to be associated with lower disease activity and spinal pain. However, these findings may reflect confounding by sex and smoking. Further longitudinal cohort studies with standardized measures for AC are warranted to assess the direction of alcohol's effect on structural damage progression.
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Affiliation(s)
- Evelyne Gendron
- Schroeder Arthritis Institute, Division of Rheumatology, Toronto Western Hospital, University of Toronto, 399 Bathurst Street, Toronto, ON M5T2S8, Canada.
| | - Sinead Maguire
- Schroeder Arthritis Institute, Division of Rheumatology, Toronto Western Hospital, University of Toronto, 399 Bathurst Street, Toronto, ON M5T2S8, Canada
| | - Melanie Anderson
- The Institute for Education Research, Library and Information Services, University Health Network, 222 St. Patrick Street, Toronto, ON M5T 1V4, Canada
| | - Sindhu R Johnson
- Schroeder Arthritis Institute, Division of Rheumatology, Toronto Western Hospital, University of Toronto, 399 Bathurst Street, Toronto, ON M5T2S8, Canada; Division of Rheumatology, Department of Medicine, Mount Sinai Hospital, 60 Murray Street, 2nd Floor, Toronto, ON M5T 3L9, Canada; Clinical Epidemiology & Health Care Research, Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College Street, Suite 425, Toronto, ON M5T 3M6, Canada
| | - Robert D Inman
- Schroeder Arthritis Institute, Division of Rheumatology, Toronto Western Hospital, University of Toronto, 399 Bathurst Street, Toronto, ON M5T2S8, Canada; Krembil Research Institute, University Health Network, University of Toronto, 60 Leonard Avenue, Toronto, ON M5T 0S8, Canada
| | - Nigil Haroon
- Schroeder Arthritis Institute, Division of Rheumatology, Toronto Western Hospital, University of Toronto, 399 Bathurst Street, Toronto, ON M5T2S8, Canada; Krembil Research Institute, University Health Network, University of Toronto, 60 Leonard Avenue, Toronto, ON M5T 0S8, Canada
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Portier E, Benattar L, Resche-Rigon M, Dougados M, Gossec L, Molto A. Different disease activity trajectories in early axial spondyloarthritis lead to significantly different long-term outcomes: a trajectory-based analysis of the DESIR cohort over 10 years. RMD Open 2024; 10:e004910. [PMID: 39710430 PMCID: PMC11664343 DOI: 10.1136/rmdopen-2024-004910] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/25/2024] [Accepted: 11/22/2024] [Indexed: 12/24/2024] Open
Abstract
INTRODUCTION The study aimed to identify and describe disease activity trajectories over 10 years in patients with recent-onset axial spondyloarthritis (axSpA) and determine their impact on long-term outcomes. METHODS This prospective, multicentre study (Devenir des Spondylarthropathies Indifférenciées Récentes cohort, ClinicalTrials.gov NCT) followed patients with early axSpA for 10 years. Only patients with at least three Axial Spondylitis Disease Activity Score (ASDAS) values were included. Long-term outcomes assessed were TNF inhibitors (TNFi) exposure, structural progression, function (Bath Ankylosing Spondylitis Functional Index (BASFI) and Bath Ankylosing Spondylitis Metrology Index), quality of life (36-items Short Form Survey), sick leave days and cardiovascular (CV) events. ASDAS trajectories were identified using k-means clustering. Multinomial multivariable regression estimated associations between baseline characteristics and trajectories. Long-term outcomes for each trajectory were described. RESULTS Among 601 patients, five ASDAS trajectories were identified: persistent low disease activity/remission (tA), clinically important improvement (tD) and persistent moderate (tB), high (tC) or very high (tE) disease activity. Patients in tA were more likely to be male, have a university degree, have white-collar jobs, have positive HLA B27 status and have less fibromyalgia. Trajectory tE was linked to poorer function (BASFI 50/100 vs 7/100 for lower ASDAS trajectory), higher TNFi exposure (74% vs 29%) and more CV events (5.7% vs 0). Structural progression was low but comparable across trajectories, except for higher sacroiliac joint progression in tB. CONCLUSION The k-means method revealed distinct disease activity trajectories in axSpA. Higher disease activity trajectories were associated with a higher prevalence of fibromyalgia and poorer outcomes, except for structural progression, which was comparable across trajectories.
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Affiliation(s)
- Elodie Portier
- Rheumatology, Hopital Cochin, Université Paris Descartes Faculté de Médecine, Paris, France
| | - Leslie Benattar
- Rheumatology, Hopital Cochin, Université Paris Descartes Faculté de Médecine, Paris, France
| | - Matthieu Resche-Rigon
- Centre of Epidemiological Research and Statistics Paris Cité (CRESS - U1153), Paris, France
| | - Maxime Dougados
- Rheumatology, Hopital Cochin, Université Paris Descartes Faculté de Médecine, Paris, France
- Centre of Epidemiological Research and Statistics Paris Cité (CRESS - U1153), Paris, France
| | - Laure Gossec
- INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Universite, Paris, France
- APHP, Rheumatology Department, Hopital Universitaire Pitie Salpetriere, Paris, France
| | - Anna Molto
- Rheumatology, Hopital Cochin, Université Paris Descartes Faculté de Médecine, Paris, France
- Centre of Epidemiological Research and Statistics Paris Cité (CRESS - U1153), Paris, France
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Capelusnik D, Nikiphorou E, Boonen A, Christensen R, van der Heijde D, Landewé R, van Tubergen A, Ramiro S. Comparing the construct validity of measurement instruments for pain and stiffness in patients with axial spondyloartwhritis: cross-sectional analysis in the OASIS cohort. RMD Open 2024; 10:e004775. [PMID: 39658054 PMCID: PMC11647358 DOI: 10.1136/rmdopen-2024-004775] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/18/2024] [Accepted: 11/04/2024] [Indexed: 12/12/2024] Open
Abstract
OBJECTIVES To compare the construct validity, including discrimination between known groups, of three pain and three morning stiffness (MS) measurement instruments. METHODS Patients with radiographic axial spondyloarthritis with 8-year data from the Outcome in Ankylosing Spondylitis International Study cohort were assessed cross-sectionally. Three instruments for pain and three for MS, all self-reported and scored 0-10, were compared. Construct validity was evaluated by testing (1) hypothesis of correlations' strength and (2) discrimination between known groups using standardised mean differences (SMD) across external constructs. Influence of contextual factors (CFs) on SMDs was investigated. RESULTS Of 85 patients, mean age was 54 (SD 11), mean symptom duration 31 (11) years, 71% males. All six instruments showed a good construct validity by fulfilling >75% of the hypotheses for the strength of correlation. Neck/back/hip pain (Bath Ankylosing Spondylitis Disease Activity Index-Question 2, BASDAI-Q2) and total back pain had higher SMDs compared with back pain at night across all between-group comparisons, with BASDAI-Q2 performing mostly slightly better (eg, SMD for external construct Axial Spondyloarthritis Disease Activity Score (ASDAS; ≥2.1 vs <2.1): 1.87 (BASDAI-Q2) vs 1.56 (total back pain) vs 1.07 (back pain at night)). MS-severity and severity/duration had higher SMDs across all external constructs (with MS-severity slightly better), while MS-duration performed worse (eg, SMD external construct ASDAS: 1.51 (MS-severity) and 1.39 (MS-severity/duration) vs 1.16 (MS-duration)). Influence of CFs on known group discrimination was limited. CONCLUSIONS The recommended Assessment of SpondyloArthritis international Society Core Outcome Set (ASAS-COS) pain measurement instrument total back pain BASDAI-Q2 has the best known group discrimination. For MS, the ASAS-COS stiffness measure (MS-severity/duration) performs well although MS-severity even slightly better. Known group discrimination is overall stable across CFs.
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Affiliation(s)
- Dafne Capelusnik
- Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, Netherlands
- Rheumatology, Tel Aviv Sourasky Medical Center–Ichilov, Tel Aviv, Israel
| | - Elena Nikiphorou
- Centre for Rheumatic Diseases, King’s College Hospital Charity, London, UK
- Rheumatology, King’s College Hospital Charity, London, UK
| | - Annelies Boonen
- Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, Netherlands
- Department of Rheumatology, Maastricht University Medical Centre+, Maastricht, Netherlands
| | - Robin Christensen
- Section for Biostatistics and Evidence-Based Research, Bispebjerg Hospital, Kobenhavn, Denmark
- Clinical Research, Odense University Hospital, Odense, Denmark
| | | | - Robert Landewé
- Clinical Immunology and Rheumatology, Amsterdam University Medical Centres, Amsterdam, Netherlands
- Rheumatology, Zuyderland Medical Centre, Sittard-Geleen, Netherlands
| | - Astrid van Tubergen
- Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, Netherlands
- Department of Rheumatology, Maastricht University Medical Centre+, Maastricht, Netherlands
| | - Sofia Ramiro
- Rheumatology, Leiden University Medical Center, Leiden, Netherlands
- Department of Rheumatology, Zuyderland Medical Centre Heerlen, Heerlen, Netherlands
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Kharouf F, Gladman DD. Advances in the management of psoriatic arthritis in adults. BMJ 2024; 387:e081860. [PMID: 39572047 DOI: 10.1136/bmj-2024-081860] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/26/2024]
Abstract
Psoriatic arthritis is an inflammatory arthritis that affects around 30% of patients with psoriasis. The disease spectrum includes peripheral arthritis, enthesitis, tenosynovitis, dactylitis, axial involvement, and skin and nail psoriasis in most patients. In addition to the cutaneous and musculoskeletal manifestations, several comorbidities can complicate the disease course, including cardiovascular disease, diabetes mellitus, metabolic syndrome, gout, anxiety, and depression. The management of patients with psoriatic arthritis begins with a careful assessment of the skin and joints and screening for comorbidities. This review describes the assessment tools and outcome measures used in the evaluation of patients with psoriatic arthritis. It summarizes the approach to therapy, including non-medicinal interventions such as education, lifestyle changes, physiotherapy, and occupational therapy. It discusses the evidence on pharmacologic treatments, including drugs used for symptomatic relief such as non-steroidal anti-inflammatory drugs, and those used to control the disease process; this last group comprises conventional synthetic disease modifying anti-rheumatic drugs (DMARDs), including methotrexate, leflunomide, and sulfasalazine, and biologic and targeted DMARDs, including anti-tumor necrosis factor (TNFα), anti-interleukin-17 (IL-17), anti-IL-12/23, and anti-IL-23 agents, as well as Janus kinase (JAK) inhibitors and phosphodiesterase 4 (PDE4) antagonists. Although these drugs are usually tailored to the clinical profile of the patient, biomarkers predictive of response to therapy are needed so that a more personalized approach can be followed.
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Affiliation(s)
- Fadi Kharouf
- University of Toronto, Psoriatic Arthritis Program, University Health Network, Toronto Western Hospital, Toronto, ON, Canada
- Gladman-Krembil Psoriatic Disease Program, Toronto Western Hospital, Toronto, ON, Canada
| | - Dafna D Gladman
- University of Toronto, Psoriatic Arthritis Program, University Health Network, Toronto Western Hospital, Toronto, ON, Canada
- Gladman-Krembil Psoriatic Disease Program, Toronto Western Hospital, Toronto, ON, Canada
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Kharouf F, Gladman DD. Treatment controversies in spondyloarthritis and psoriatic arthritis: focus on biologics and targeted therapies. Expert Rev Clin Immunol 2024; 20:1381-1400. [PMID: 39072530 DOI: 10.1080/1744666x.2024.2384705] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/20/2024] [Accepted: 07/22/2024] [Indexed: 07/30/2024]
Abstract
INTRODUCTION There are several treatment controversies that have emerged in spondyloarthritis and psoriatic arthritis. These are related to the nature of the conditions as well as to the use of medications. AREAS COVERED This review, which included a search of PubMed database as well as the references within the articles provides an overview of the nature of spondyloarthritis, controversy over the inclusion of psoriatic arthritis (PsA) as a peripheral spondyloarthritis, and a summary of current treatments for both PsA and axial spondyloarthritis (axSpA), with special emphasis on targeted therapy. The review highlights the differences in response to certain medications, particularly biologic therapy and summarizes the randomized controlled trials in psoriatic arthritis and axial spondyloarthritis providing data about the responses in table format. EXPERT OPINION There is a need for better outcome measures in axSpA. Currently, the measures are subjective. Imaging may be more appropriate but there is a need for research into the reliability and responsiveness of imaging techniques. In PsA, there may also be better response measures and research into the reliability and responsiveness of available measures is underway. There is also a need for novel therapies as well as biomarkers for response in both diseases.
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Affiliation(s)
- Fadi Kharouf
- Division of Rheumatology, University Health Network, University of Toronto, Toronto, Ontario, Canada
- Gladman-Krembil Psoriatic Disease Program, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada
| | - Dafna D Gladman
- Division of Rheumatology, University Health Network, University of Toronto, Toronto, Ontario, Canada
- Gladman-Krembil Psoriatic Disease Program, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada
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Ocak T, Yağız B, Ocak B, Yoğurtçu Ö, Başıbüyük F, Tezcan D, Ermurat S, İnanç E, Yamancan G, Albayrak F, Sağır RP, Bayındır Akbaş AN, Cüre O, Coşkun BN, Yolbaş S, Karasu U, Kısacık B, Koca SS, Sarı İ, Akar S, Dalkılıç E, Pehlivan Y. Secukinumab May Be an Effective Treatment Option for Axial Spondyloarthritis and Psoriatic Arthritis Patients with a History of Malignancy: Multicenter Real-Life Experience from Turkey. J Clin Med 2024; 13:6216. [PMID: 39458166 PMCID: PMC11509106 DOI: 10.3390/jcm13206216] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/13/2024] [Revised: 10/14/2024] [Accepted: 10/16/2024] [Indexed: 10/28/2024] Open
Abstract
Background: Secukinumab is a monoclonal antibody against interleukin 17 approved for patients with axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), and psoriasis. Treating axSpA and PsA patients with a history of malignancy is a challenge. While initial results on the applicability of secukinumab in this patient group are positive, the number of studies on this topic remains limited. This study aimed to investigate the drug's survival time and the efficacy and safety of secukinumab treatment in this specific patient group. Methods: This retrospective study included 30 patients with a history of malignancy who were followed up in rheumatology outpatient clinics in 12 centers throughout Turkey and treated with secukinumab between May 2018 and March 2024 with a diagnosis of axSpA and PsA. Results: The mean follow-up time was 29.8 ± 19.3 months. The drug retention rate was 89.7% after 12 months and 80.6% after 24 months. The most common tumor in our study was papillary thyroid carcinoma (n = 5, 16.7%). During follow-up, local tumor recurrence was observed in a patient with urothelial carcinoma of the bladder. Conclusions: In the largest cohort reported to date, treatment with secukinumab in axSpA and PsA patients with a history of malignancy was not shown to cause oncologic recurrence except for one local tumor recurrence. Drug retention rates were also high, and disease activation and function improved compared to baseline. Therefore, secukinumab could be a safe and effective option for this patient group.
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Affiliation(s)
- Tuğba Ocak
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Uludağ University, 16285 Bursa, Turkey; (B.Y.); (B.N.C.); (E.D.); (Y.P.)
| | - Burcu Yağız
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Uludağ University, 16285 Bursa, Turkey; (B.Y.); (B.N.C.); (E.D.); (Y.P.)
| | - Birol Ocak
- Department of Medical Oncology, Bursa Yüksek İhtisas Training and Research Hospital, 16140 Bursa, Turkey;
| | - Özge Yoğurtçu
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, İzmir Katip Çelebi University, 35620 İzmir, Turkey; (Ö.Y.); (S.A.)
| | - Fatma Başıbüyük
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Dokuz Eylül University, 35340 İzmir, Turkey; (F.B.); (İ.S.)
| | - Dilek Tezcan
- Division of Rheumatology, Department of Internal Medicine, Gülhane Faculty of Medicine, University of Health Sciences, 06018 Ankara, Turkey;
| | - Selime Ermurat
- Department of Rheumatology, Bursa Yüksek İhtisas Training and Research Hospital, 16140 Bursa, Turkey;
| | - Elif İnanç
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, İnönü University, 44000 Malatya, Turkey; (E.İ.); (S.Y.)
| | - Gülşah Yamancan
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Fırat University, 23119 Elazığ, Turkey; (G.Y.); (S.S.K.)
| | - Fatih Albayrak
- Department of Rheumatology, Gaziantep City Hospital, 27470 Gaziantep, Turkey;
| | - Rabia Pişkin Sağır
- Department of Rheumatology, Bitlis Tatvan State Hospital, 13200 Bitlis, Turkey;
| | - Ayşe Nur Bayındır Akbaş
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Pamukkale University, 20070 Denizli, Turkey; (A.N.B.A.); (U.K.)
| | - Osman Cüre
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Recep Tayyip Erdoğan University, 53100 Rize, Turkey;
| | - Belkıs Nihan Coşkun
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Uludağ University, 16285 Bursa, Turkey; (B.Y.); (B.N.C.); (E.D.); (Y.P.)
| | - Servet Yolbaş
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, İnönü University, 44000 Malatya, Turkey; (E.İ.); (S.Y.)
| | - Uğur Karasu
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Pamukkale University, 20070 Denizli, Turkey; (A.N.B.A.); (U.K.)
| | - Bünyamin Kısacık
- Department of Rheumatology, Sanko University Medical Faculty Hospital, 16049 Gaziantep, Turkey;
| | - Süleyman Serdar Koca
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Fırat University, 23119 Elazığ, Turkey; (G.Y.); (S.S.K.)
| | - İsmail Sarı
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Dokuz Eylül University, 35340 İzmir, Turkey; (F.B.); (İ.S.)
| | - Servet Akar
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, İzmir Katip Çelebi University, 35620 İzmir, Turkey; (Ö.Y.); (S.A.)
| | - Ediz Dalkılıç
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Uludağ University, 16285 Bursa, Turkey; (B.Y.); (B.N.C.); (E.D.); (Y.P.)
| | - Yavuz Pehlivan
- Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Uludağ University, 16285 Bursa, Turkey; (B.Y.); (B.N.C.); (E.D.); (Y.P.)
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Khampaen T, Kafaksom T, Dechapaphapitak N, Tongdee N, Chevaisrakul P. Correlations among quality of life, spinal mobility, and disease activity in early-treated axial spondyloarthritis: a single-center cross-sectional study. BMC Rheumatol 2024; 8:54. [PMID: 39415300 PMCID: PMC11481462 DOI: 10.1186/s41927-024-00426-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/13/2024] [Accepted: 10/04/2024] [Indexed: 10/18/2024] Open
Abstract
BACKGROUND Axial spondyloarthritis (axSpA) significantly impacts patients' lives. The ASAS-OMERACT guideline was formulated for the multidimensional evaluation of axSpA patients, employing a specific set of tools. Given the pivotal role of patient perception, comprehensive correlation among these tools, especially concerning quality of life, may provide a clinically relevant perspective and enhance treatment efficacy in the early stages of the disease. This study aims to investigate the correlation among disease activity, functional ability, and quality of life in early-treated axSpA patients. In addition, the association between high disease activity and clinical characteristics was explored. METHODS This cross-sectional study was conducted in a tertiary hospital in Thailand. Patients diagnosed with axSpA according to ASAS classification criteria and receiving treatment from rheumatologists within three years of onset of symptoms were included. Clinical and laboratory data were retrieved from a hospital database. Disease activity was assessed using the Ankylosing Spondylitis Disease Activity Score with ESR or CRP (ASDAS-ESR/CRP) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Spinal mobility was measured using the Bath Ankylosing Spondylitis Metrology Index (BASMI), while quality of life and function were evaluated using the ASAS Health Index (ASAS-HI) and Bath Ankylosing Spondylitis Functional Index (BASFI), respectively. The correlation between these measurements was analyzed using the Pearson correlation coefficient (r). Additionally, factors associated with high disease activity (ASDAS/CRP > 2.1) were explored using multivariate regression analysis. RESULTS Sixty-six patients (41 males; mean age 49.3 ± 13.3 years) were enrolled between April to December 2022. Disease activity (ASDAS-CRP) was significantly inversely correlated with spinal mobility (BASMI), function (BASFI), and quality of life (ASAS-HI). High disease activity was associated with obesity (BMI ≥ 30 kg/m^2) and a longer duration of symptoms before treatment (≥ 2 years). CONCLUSION In early-treated axSpA patients, ASDAS-CRP showed significant correlations with functional ability, quality of life, and spinal mobility. High disease activity was associated with obesity and a longer pre-treatment symptom duration in our study. Early treatment may enhance patients' function, mobility, and quality of life, with weight reduction being possibly beneficial for obese axSpA patients. CLINICAL TRIAL NUMBER Not applicable.
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Affiliation(s)
- Tinh Khampaen
- Division of Allergy, Immunology, and Rheumatology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Thung Phayathai Subdistrict, Ratchathewi, Bangkok, 10400, Thailand.
| | - Thanuchporn Kafaksom
- Division of Allergy, Immunology, and Rheumatology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Thung Phayathai Subdistrict, Ratchathewi, Bangkok, 10400, Thailand
| | - Nichapa Dechapaphapitak
- Division of Allergy, Immunology, and Rheumatology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Thung Phayathai Subdistrict, Ratchathewi, Bangkok, 10400, Thailand
| | - Nattakirana Tongdee
- Division of Allergy, Immunology, and Rheumatology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Thung Phayathai Subdistrict, Ratchathewi, Bangkok, 10400, Thailand
| | - Parawee Chevaisrakul
- Division of Allergy, Immunology, and Rheumatology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Thung Phayathai Subdistrict, Ratchathewi, Bangkok, 10400, Thailand
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Pimentel CQ, Medeiros-Ribeiro AC, Shimabuco AY, Sampaio-Barros PD, Moraes JCB, Schainberg CG, Gonçalves CR, Leon EP, Kupa LDVK, Pasoto SG, Aikawa NE, Silva CA, Bonfa E, Saad CGS. Long-Term Follow-Up of Anti-Infliximab Antibodies in Patients With Radiographic Axial Spondyloarthritis: A Marker of Drug Survival and Tapering. Arthritis Rheumatol 2024; 76:1488-1500. [PMID: 38801195 DOI: 10.1002/art.42923] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2023] [Revised: 04/01/2024] [Accepted: 05/22/2024] [Indexed: 05/29/2024]
Abstract
OBJECTIVE The aim of this study was to evaluate the influence of anti-infliximab (IFX) antibodies on three different points of care: response/tolerance to IFX, tapering strategy, and in a subsequent treatment with a second tumor necrosis factor inhibitor (TNFi). METHODS A prospective cohort of 60 patients with radiographic axial spondyloarthritis who received IFX were evaluated retrospectively regarding clinical/laboratorial data, IFX levels, and anti-IFX antibodies at baseline, after 6, 12 to 14, 22 to 24, 48 to 54, 96 to 102 weeks, and before tapering or switching. RESULTS Anti-IFX antibodies were detected in 27 patients (45%), of whom 23 (85.1%) became positive in the first year of IFX treatment. In comparison to the group that was negative for anti-IFX antibodies, patients who were positive for anti-IFX antibodies demonstrated the following: less use of methotrexate as a concomitant treatment to IFX (5 [18.5%] vs 14 [42.4%]; P = 0.048), more infusion reactions at 22 to 24 weeks (P = 0.020) and 48 to 54 weeks (P = 0.034), more treatment failures (P = 0.028) at 48 to 54 weeks, reduced overall IFX survival (P < 0.001), and lower sustained responses (P = 0.044). Of note, patients who were positive for anti-IFX antibodies exhibited a shorter tapering survival (9.9 months [95% confidence interval (CI) 4.0-15.8] vs 63.4 months [95% CI 27.9-98.8]; P = 0.004) in comparison with patients who were negative for anti-IFX antibodies. Conversely, for patients who failed IFX, patients who were positive for anti-IFX antibodies had better clinical response to the second TNFi at three months (15 [83.3%] vs 3 [27.3%]; P = 0.005) and six months (15 [83.3%] vs 4 [36.4%]; P = 0.017) than the patients who were negative for anti-IFX antibodies after switching. CONCLUSION This study provided novel data that anti-IFX antibodies is a parameter for reduced tapering survival, reinforcing its detection to guide clinical decision. Additionally, we confirmed in a long-term cohort the anti-IFX antibody association with worse IFX performance and as predictor of the second TNFi good clinical response.
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Affiliation(s)
- Clarissa Q Pimentel
- Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
| | - Ana Cristina Medeiros-Ribeiro
- Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
| | - Andrea Y Shimabuco
- Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
| | - Percival D Sampaio-Barros
- Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
| | - Júlio César B Moraes
- Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
| | - Claudia G Schainberg
- Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
| | - Celio Roberto Gonçalves
- Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
| | - Elaine P Leon
- Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
| | - Léonard De Vinci K Kupa
- Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
| | - Sandra G Pasoto
- Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
| | - Nádia E Aikawa
- Pediatric Rheumatology Unit, Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
| | - Clovis A Silva
- Pediatric Rheumatology Unit, Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
| | - Eloisa Bonfa
- Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
| | - Carla G S Saad
- Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
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Çabuk B, Bulut Gökten D, Solakoğlu T, Mete R, Türkel Küçükmetin N, Mercan R. A single-center experience: Enteropathic arthritis in inflammatory bowel diseases. THE EGYPTIAN RHEUMATOLOGIST 2024; 46:171-174. [DOI: 10.1016/j.ejr.2024.07.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/11/2024]
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Pereira GC, Machado NP, Gomes AF, Assad RL, Carneiro FH, Azevedo VF. Sacroiliac and spine imaging in spondyloarthritis: Does phenotype or sex matter? Adv Rheumatol 2024; 64:68. [PMID: 39256831 DOI: 10.1186/s42358-024-00411-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2023] [Accepted: 08/25/2024] [Indexed: 09/12/2024] Open
Abstract
BACKGROUND Spondyloarthritis (SpA) encompasses a spectrum of immune-mediated inflammatory conditions primarily affecting the axial skeleton, including sacroiliitis and spondylitis, each with distinct features. This study aimed to investigate imaging disparities, focusing on sacroiliac magnetic resonance and spine radiography, across phenotypes and between males and females in axial SpA. METHOD A cross-sectional study was conducted to assess clinical data, laboratory findings, magnetic resonance imaging (MRI) scores of sacroiliac joints using the Spondyloarthritis Research Consortium of Canada (SPARCC) and Sacroiliac Joint Structural Score (SSS), and cervical and lumbar spine radiographs utilizing the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The study aimed to compare these parameters between two groups: axial spondyloarthritis (axSpA, radiographic and non-radiographic) and axial psoriatic arthritis (axPsA), as well as between males and females. RESULTS Ninety-four patients were included, with 62 patients in the axSpA group and 32 patients in the axPsA group. There were no differences in disease activity, mobility, radiographic damage in the spine (Modified Stoke Ankylosing Spondylitis Spine Score- mSASSS), or sacroiliac magnetic resonance imaging (MRI) scores (Spondyloarthritis Research Consortium of Canada Magnetic Resonance Imaging Index - SPARCC and Sacroiliac Joint Structural Score - SSS) between the two phenotypes. Regarding sex, in imaging exams, men had higher mSASSS (p = 0.008), SSS (p = 0.001), and fat metaplasia (MG) score based on SSS (p = 0.001), while women had significantly higher SPARCC scores (p = 0.039). In the male group, the presence of HLA-B27 allele had an impact on more structural lesions on MRI (SSS), p = 0.013. CONCLUSION In this study, imaging of sacroiliac joints and spine in patients with axial SpA did not show differences in phenotypes but did reveal differences based on sex, which may have an impact on future diagnostic recommendations. Further studies are needed to confirm these findings.
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Dalix E, Marcelli C, Bejan-Angoulvant T, Finckh A, Rancon F, Akrour M, De Araujo L, Presles E, Marotte H. Rotation or change of biotherapy after TNF blocker treatment failure for axial spondyloarthritis: the ROC-SpA study, a randomised controlled study protocol. BMJ Open 2024; 14:e087872. [PMID: 39260856 PMCID: PMC11409346 DOI: 10.1136/bmjopen-2024-087872] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/21/2024] [Accepted: 08/20/2024] [Indexed: 09/13/2024] Open
Abstract
INTRODUCTION Axial spondyloarthritis (axSpA) is a chronic inflammatory disease characterised by inflammatory low back pain. Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as a first treatment in axSpA. In case of inadequate response to NSAIDs, biological disease-modifying antirheumatic drugs (bDMARDs) should be introduced according to the recommendations of the European League Against Rheumatism (EULAR) and the American College of Rheumatology. Until 2015, only bDMARD was recommended for axSpA in case of failure to anti-tumour necrosis factor (TNF). The 2022 Assessment of SpondyloArthritis International Society (ASAS)-EULAR recommendation proposed to start an alternative bDMARD but without advocating a switch in mode of action as proposed in rheumatoid arthritis. Since 2015, the inhibition of interleukin (IL)-17 has demonstrated efficacy in axSpA. Then, we designed a randomised multicentre clinical trial to identify the more effective treatment after a first anti-TNF failure in axSpA, comparing an anti-IL-17 to a second anti-TNF. METHODS AND ANALYSIS The ROC-SpA (Rotation Or Change of biotherapy after first anti-TNF treatment failure in axSpA patients) study is a prospective, randomised, multicentre, superiority open-label phase IV trial comparing an anti-IL-17 strategy (secukinumab or ixekizumab) to a second TNF blocker in a 1:1 ratio. Patients with an active axSpA (Bath Ankylosing Spondylitis Disease Activity Index >4 or ankylosing spondylitis disease activity score (ASDAS) >3.5) with inadequate 3 months response to a first anti-TNF and with a stable dose of conventional synthetic DMARDs, oral corticosteroids and/or NSAIDs for at least 1 month are included in 31 hospital centres in France and Monaco. The primary outcome is the ASAS40 response at week 24. The secondary outcomes are ASAS40 at weeks 12 and 52, other clinical scores (ASAS20, partial remission rate, ASDAS major improvement rate) at weeks 12, 24 and 52 with the drugs and anti-drugs concentrations at baseline, weeks 12, 24 and 52. The primary analysis is performed at the end of the study according to the intent-to-treat principle. ETHICS AND DISSEMINATION Ethics approval was obtained from the committee for the protection of persons (Comité de protection des personnes Ouest IV #12/18_1, 6 February 2018) and registered in ClinicalTrials.gov and in EudraCT. Results of this study, whether positive or negative, will be presented at national and international congresses, to national axSpA patient associations and published in a peer-reviewed journal. It could also impact the international recommendation to manage patients with axSpA. TRIAL REGISTRATION NUMBER NCT03445845 and EudraCT2017-004700-22.
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Affiliation(s)
- Elisa Dalix
- University Jean Monnet Saint-Etienne, Mines Saint-Etienne, INSERM, SAINBIOSE U1059, Saint-Etienne, France
| | - Christian Marcelli
- Department of Rheumatology, Caen University Hospital University and INSERM, UniCaen, U1075, COMETE, PFRS, Normandie University, Caen, France
| | - Theodora Bejan-Angoulvant
- Centre Hospitalier Universitaire Et Faculté de Médecine, Pharmacologie Médicale, EA4245, Université de Tours, Tours, France
| | - Axel Finckh
- Division of Rheumatology, Department of Medicine, Faculty of Medicine and Geneva University Hospitals, Genev, Switzerland
| | - Florence Rancon
- Unité de Recherche Clinique, Centre d’Investigation Clinique 1408, CHU de Saint-Etienne, Saint-Etienne, France
| | - Madjid Akrour
- Unité de Recherche Clinique, Centre d’Investigation Clinique 1408, CHU de Saint-Etienne, Saint-Etienne, France
| | - Liliane De Araujo
- Unité de Recherche Clinique, Centre d’Investigation Clinique 1408, CHU de Saint-Etienne, Saint-Etienne, France
| | - Emilie Presles
- Unité de Recherche Clinique, Centre d’Investigation Clinique 1408, CHU de Saint-Etienne, Saint-Etienne, France
| | - Hubert Marotte
- CHU Saint-Etienne, Mines Saint-Etienne, Centre d’Investigation Clinique 1408, INSERM, SAINBIOSE U1059, University Jean Monnet Saint-Etienne, Saint-Etienne, France
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Braun J, Sieper J, Märker-Hermann E. Looking back on 51 years of the Carol Nachman Prize in Rheumatology-significance for the field of spondyloarthritis research. Z Rheumatol 2024; 83:563-574. [PMID: 38864856 PMCID: PMC11442482 DOI: 10.1007/s00393-024-01496-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 01/16/2024] [Indexed: 06/13/2024]
Abstract
The city and casino of Wiesbaden, capital of the German state Hessen, have endowed the Carol Nachman Prize to promote research work in the field of rheumatology since 1972. The prize, endowed with 37,500 €, is the second highest medical award in Germany and serves to promote clinical, therapeutic, and experimental research work in the field of rheumatology. In June 2022, the 50-year anniversary was celebrated. In the symposium preceding the award ceremony, an overview was given on the significance of spondyloarthritis for the work of the awardees in the past 30 years. This overview has now been put together to inform the interested community of the work performed, including the opinion of the awardees regarding what they consider to be their most important contribution.
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Affiliation(s)
- Jürgen Braun
- Rheumatologisches Versorgungszentrum Steglitz, Schloßstr. 110, 12163, Berlin, Germany.
| | - Joachim Sieper
- Rheumatologie am Campus Benjamin Franklin, Medizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Charité Universitätsmedizin Berlin, Berlin, Germany
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Zimba O, Kocyigit BF, Korkosz M. Diagnosis, monitoring, and management of axial spondyloarthritis. Rheumatol Int 2024; 44:1395-1407. [PMID: 38758383 PMCID: PMC11222196 DOI: 10.1007/s00296-024-05615-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/27/2024] [Accepted: 05/02/2024] [Indexed: 05/18/2024]
Abstract
Axial spondyloarthritis (axSpA) is a chronic condition predominantly affecting the spine and sacroiliac joints. This article provides an in-depth overview of the current approaches to diagnosing, monitoring, and managing axSpA, including insights into developing terminology and diagnostic difficulties. A substantial portion of the debate focuses on the challenging diagnostic procedure, noting the difficulty of detecting axSpA early, particularly before the appearance of radiologic structural changes. Despite normal laboratory parameters, more than half of axSpA patients experience symptoms. X-ray and magnetic resonance imaging (MRI) are essential for evaluating structural damage and inflammation. MRI can be beneficial when there is no visible structural damage on X-ray as it can help unravel bone marrow edema (BME) as a sign of ongoing inflammation. The management covers both non-pharmacological and pharmacological approaches. Lifestyle modifications, physical activity, and patient education are essential components of the management. Pharmacological therapy, including nonsteroidal anti-inflammatory drugs (NSAIDs) and biologic disease-modifying anti-rheumatic drugs (bDMARDs), are explored, emphasizing individualized treatment. To effectively manage axSpA, a comprehensive and well-coordinated approach is necessary, emphasizing the significance of a multidisciplinary team. Telehealth applications play a growing role in axSpA management, notably in reducing diagnostic delays and facilitating remote monitoring. In conclusion, this article underlines diagnostic complexities and emphasizes the changing strategy of axSpA treatment. The nuanced understanding offered here is designed to guide clinicians, researchers, and healthcare providers toward a more comprehensive approach to axSpA diagnosis and care.
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Affiliation(s)
- Olena Zimba
- Department of Rheumatology, Immunology and Internal Medicine, University Hospital in Krakow, Krakow, Poland
- National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland
- Department of Internal Medicine N2, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine
| | - Burhan Fatih Kocyigit
- Department of Physical Medicine and Rehabilitation, University of Health Sciences, Adana City Research and Training Hospital, Adana, Türkiye
| | - Mariusz Korkosz
- Department of Rheumatology, Immunology and Internal Medicine, University Hospital in Krakow, Krakow, Poland.
- Department of Rheumatology and Immunology, Jagiellonian University Medical College, Jakubowskiego 2 Str., 30-688, Kraków, Poland.
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Maksymowych WP, Thom H, Mørup MF, Taieb V, Willems D, Lyris N, Gaffney K. Matching-Adjusted Indirect Comparison of the 52-Week Efficacy of Bimekizumab Versus Secukinumab and Ixekizumab for the Treatment of Radiographic Axial Spondyloarthritis. Rheumatol Ther 2024; 11:1023-1041. [PMID: 38916823 PMCID: PMC11265043 DOI: 10.1007/s40744-024-00684-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/22/2024] [Accepted: 05/22/2024] [Indexed: 06/26/2024] Open
Abstract
INTRODUCTION A previous network meta-analysis established 16-week relative efficacy with bimekizumab, an inhibitor of interleukin (IL)-17F in addition to IL-17A, versus other treatments for patients with radiographic axial spondyloarthritis (r-axSpA; i.e., ankylosing spondylitis), including the IL-17A inhibitors secukinumab and ixekizumab. This matching-adjusted indirect comparison (MAIC) assessed 52-week relative efficacy of bimekizumab versus secukinumab and ixekizumab. METHODS Individual patient data from BE MOBILE 2 (bimekizumab 160 mg; N = 220) were matched to pooled summary data from MEASURE 1/2/3/4 (secukinumab 150 mg), MEASURE 3 (secukinumab 300 mg; escalated dose for inadequate responders), COAST-V (ixekizumab) and COAST-V/-W (ixekizumab). BE MOBILE 2 patients were reweighted using propensity score weights based on age, sex, ethnicity, tumor necrosis factor inhibitor (TNFi) exposure, weight, baseline ASDAS and BASFI (secukinumab) and baseline BASDAI (ixekizumab), and 52-week efficacy outcomes from the trial recalculated. Odds ratios (OR) or mean difference for unanchored comparisons are reported with 95% confidence intervals (CI). RESULTS At week 52, MAIC demonstrated that patients may have higher likelihood of improvement in key efficacy outcomes with bimekizumab versus secukinumab 150 mg (e.g., ASAS40: [OR (95% CI): 1.48 (1.05, 2.10); p = 0.026]; effective sample size [ESS] = 177). Differences in 52-week efficacy outcomes between bimekizumab and secukinumab 300 mg dose escalation were non-significant (ESS = 120). Bimekizumab versus ixekizumab 80 mg comparisons (COAST-V only; ESS = 84) also suggested that differences were non-significant for most key efficacy outcomes. Other ixekizumab comparisons (COAST-V/-W; ESS = 45) suggested bimekizumab may have higher comparative efficacy for many of the same efficacy outcomes, however ixekizumab analyses were limited by poor population overlap, likely due to the greater proportion of patients with previous TNFi exposure. CONCLUSIONS Patients treated with bimekizumab may have a higher likelihood of achieving improved longer-term efficacy versus secukinumab 150 mg, suggesting bimekizumab may be a favorable therapeutic option for r-axSpA. Differences in efficacy outcomes with bimekizumab versus ixekizumab 80 mg were mostly non-significant, depending on the populations considered.
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Affiliation(s)
| | - Howard Thom
- University of Bristol, Bristol, UK
- Clifton Insight, Bristol, UK
| | | | | | | | | | - Karl Gaffney
- Norfolk and Norwich University Hospital NHS Trust, Norfolk, UK
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Worth C, Al-Mossawi MH, Macdonald J, Fisher BA, Chan A, Sengupta R, Packham J, Gaffney K, Gullick N, Cook JA, Corn TH, Teh J, Machado PM, Taylor PC, Bowness P. Granulocyte-macrophage colony-stimulating factor neutralisation in patients with axial spondyloarthritis in the UK (NAMASTE): a randomised, double-blind, placebo-controlled, phase 2 trial. THE LANCET. RHEUMATOLOGY 2024; 6:e537-e545. [PMID: 38942047 DOI: 10.1016/s2665-9913(24)00099-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/29/2023] [Revised: 03/15/2024] [Accepted: 04/15/2024] [Indexed: 06/30/2024]
Abstract
BACKGROUND Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a proinflammatory cytokine overproduced in several inflammatory and autoimmune diseases, including axial spondyloarthritis. Namilumab is a human IgG1 monoclonal anti-GM-CSF antibody that potently neutralises human GM-CSF. We aimed to assess the efficacy of namilumab in participants with moderate-to-severe active axial spondyloarthritis. METHODS This proof-of-concept, randomised, double-blind, placebo-controlled, phase 2, Bayesian (NAMASTE) trial was done at nine hospitals in the UK. Participants aged 18-75 years with axial spondyloarthritis, meeting the Assessment in SpondyloArthritis international Society (ASAS) criteria and the ASAS-defined MRI criteria, with active disease as defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), were eligible. Those who had inadequately responded or had intolerance to previous treatment with an anti-TNF agent were included. Participants were randomly assigned (6:1) to receive subcutaneous namilumab 150 mg or placebo at weeks 0, 2, 6, and 10. Participants, site staff (except pharmacy staff), and central study staff were masked to treatment assignment. The primary endpoint was the proportion of participants who had an ASAS ≥20% improvement (ASAS20) clinical response at week 12 in the full analysis set (all randomly assigned participants). This trial is registered with ClinicalTrials.gov (NCT03622658). FINDINGS From Sept 6, 2018, to July 25, 2019, 60 patients with moderate-to-severe active axial spondyloarthritis were assessed for eligibility and 42 were randomly assigned to receive namilumab (n=36) or placebo (n=six). The mean age of participants was 39·5 years (SD 13·3), 17 were women, 25 were men, 39 were White, and seven had previously received anti-TNF therapy. The primary endpoint was not met. At week 12, the proportion of patients who had an ASAS20 clinical response was lower in the namilumab group (14 of 36) than in the placebo group (three of six; estimated between-group difference 6·8%). The Bayesian posterior probability η was 0·72 (>0·927 suggests high clinical significance). The rates of any treatment-emergent adverse events in the namilumab group were similar to those in the placebo group (31 vs five). INTERPRETATION Namilumab did not show efficacy compared with placebo in patients with active axial spondyloarthritis, but the treatment was generally well tolerated. FUNDING Izana Bioscience, NIHR Oxford Biomedical Research Centre (BRC), NIHR Birmingham BRC, and Clinical Research Facility.
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Affiliation(s)
- Claudia Worth
- Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
| | - M Hussein Al-Mossawi
- Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
| | - Joanne Macdonald
- Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
| | - Benjamin A Fisher
- Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK; National Institute for Health Research (NIHR), Birmingham Biomedical Research Centre, Department of Rheumatology, University Hospitals Birmingham, NHS Foundation Trust, Birmingham, UK
| | - Antoni Chan
- Royal Berkshire, NHS Foundation Trust, Reading, UK
| | | | | | - Karl Gaffney
- Norfolk and Norwich University Hospitals, NHS Foundation Trust, Norwich, UK
| | - Nicola Gullick
- University Hospitals Coventry and Warwickshire, Warwick Medical School, University of Warwick, Warwick, UK
| | - Jonathan A Cook
- Centre for Statistics in Medicine, University of Oxford, Oxford, UK
| | - Tim H Corn
- Asclepius Consulting (Izana Bioscience), London, UK
| | - James Teh
- Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
| | - Pedro M Machado
- Centre for Rheumatology and Department of Neuromuscular Diseases, University College London, London, UK; NIHR, University College London Hospitals, Biomedical Research Centre, NHS Foundation Trust, London, UK; Department of Rheumatology, Northwick Park Hospital, London North West University Healthcare, NHS Trust, London, UK
| | - Peter C Taylor
- Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
| | - Paul Bowness
- Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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Georgiadis S, Ørnbjerg LM, Michelsen B, Kvien TK, Di Giuseppe D, Wallman JK, Závada J, Provan SA, Kristianslund EK, Rodrigues AM, Santos MJ, Rotar Ž, Pirkmajer KP, Nordström D, Macfarlane GJ, Jones GT, van der Horst-Bruinsma I, Hellamand P, Østergaard M, Hetland ML. Cut-Offs for Disease Activity States in Axial Spondyloarthritis With Ankylosing Spondylitis Disease Activity Score (ASDAS) Based on C-Reactive Protein and ASDAS Based on Erythrocyte Sedimentation Rate: Are They Interchangeable? J Rheumatol 2024; 51:673-677. [PMID: 38621792 DOI: 10.3899/jrheum.2023-1217] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 03/13/2024] [Indexed: 04/17/2024]
Abstract
OBJECTIVE Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP) is recommended over ASDAS based on erythrocyte sedimentation rate (ASDAS-ESR) to assess disease activity in axial spondyloarthritis (axSpA). Although ASDAS-CRP and ASDAS-ESR are not interchangeable, the same disease activity cut-offs are used for both. We aimed to estimate optimal ASDAS-ESR values corresponding to the established ASDAS-CRP cut-offs (1.3, 2.1, and 3.5) and investigate the potential improvement of level of agreement between ASDAS-ESR and ASDAS-CRP disease activity states when applying these estimated cut-offs. METHODS We used data from patients with axSpA from 9 European registries initiating a tumor necrosis factor inhibitor. ASDAS-ESR cut-offs were estimated using the Youden index. The level of agreement between ASDAS-ESR and ASDAS-CRP disease activity states was compared against each other. RESULTS In 3664 patients, mean ASDAS-CRP was higher than ASDAS-ESR at both baseline (3.6 and 3.4, respectively) and aggregated follow-up at 6, 12, or 24 months (1.9 and 1.8, respectively). The estimated ASDAS-ESR values corresponding to the established ASDAS-CRP cut-offs were 1.4, 1.9, and 3.3. By applying these cut-offs, the proportion of discordance between disease activity states according to ASDAS-ESR and ASDAS-CRP decreased from 22.93% to 19.81% in baseline data but increased from 27.17% to 28.94% in follow-up data. CONCLUSION We estimated the optimal ASDAS-ESR values corresponding to the established ASDAS-CRP cut-off values. However, applying the estimated cut-offs did not increase the level of agreement between ASDAS-ESR and ASDAS-CRP disease activity states to a relevant degree. Our findings did not provide evidence to reject the established cut-off values for ASDAS-ESR.
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Affiliation(s)
- Stylianos Georgiadis
- S. Georgiadis, PhD, L.M. Ørnbjerg, MD, PhD, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark;
| | - Lykke Midtbøll Ørnbjerg
- S. Georgiadis, PhD, L.M. Ørnbjerg, MD, PhD, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, Denmark
| | - Brigitte Michelsen
- B. Michelsen, MD, PhD, Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, and Research Unit, Sørlandet Hospital, Kristiansand, Norway, and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Copenhagen University Hospital Rigshospitalet, Glostrup, Denmark
| | - Tore K Kvien
- T.K. Kvien, MD, PhD, E.K. Kristianslund, MD, PhD, Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
| | - Daniela Di Giuseppe
- D. Di Giuseppe, PhD, Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden
| | - Johan K Wallman
- J.K. Wallman, MD, PhD, Department of Clinical Sciences Lund, Rheumatology, Skåne University Hospital, Lund University, Lund, Sweden
| | - Jakub Závada
- J. Závada, MD, PhD, Institute of Rheumatology, Prague, Czech Republic and Department of Rheumatology, First Faculty of Medicine, Charles University, Prague, Czech Republic
| | - Sella A Provan
- S.A. Provan, MD, PhD, Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, and Public Health Section, Inland Norway University of Applied Sciences, Elverum, Norway
| | - Eirik Klami Kristianslund
- T.K. Kvien, MD, PhD, E.K. Kristianslund, MD, PhD, Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
| | - Ana Maria Rodrigues
- A.M. Rodrigues, MD, PhD, EpiDoC Unit, CEDOC, Nova Medical School, and Rheumatology Unit, Hospital dos Lusíadas, Lisbon, Portugal
| | - Maria José Santos
- M.J. Santos, MD, PhD, Department of Rheumatology, Hospital Garcia de Orta, Almada, and Instituto Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa, Centro Académico de Medicina de Lisboa, Lisbon, Portugal
| | - Žiga Rotar
- Ž. Rotar, MD, PhD, K. Perdan Pirkmajer, MD, Department of Rheumatology, University Medical Centre Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Katja Perdan Pirkmajer
- Ž. Rotar, MD, PhD, K. Perdan Pirkmajer, MD, Department of Rheumatology, University Medical Centre Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Dan Nordström
- D. Nordström, MD, PhD, Departments of Medicine and Rheumatology, Helsinki University Hospital, Helsinki, Finland
| | - Gary J Macfarlane
- G.J. Macfarlane, MD, PhD, G.T. Jones, PhD, Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen, UK
| | - Gareth T Jones
- G.J. Macfarlane, MD, PhD, G.T. Jones, PhD, Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen, UK
| | | | - Pasoon Hellamand
- P. Hellamand, MD, Department of Rheumatology and Clinical Immunology, Amsterdam University Medical Center, Amsterdam, Netherlands and Amsterdam Rheumatology Immunology Center, Reade, and Amsterdam UMC, Amsterdam, the Netherlands
| | - Mikkel Østergaard
- M. Østergaard, MD, PhD, DMSc, M.L. Hetland, MD, PhD, DMSc, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
| | - Merete Lund Hetland
- M. Østergaard, MD, PhD, DMSc, M.L. Hetland, MD, PhD, DMSc, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Glostrup, and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
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Choi AR, Park KJ, Kang JH, Lee YJ, Jang HH, Kim MJ, Kim TJ. The effectiveness of tumor necrosis factor-α blocker therapy in patients with axial spondyloarthritis who failed conventional treatment: a comparative study focused on improvement in ASAS Health Index. JOURNAL OF RHEUMATIC DISEASES 2024; 31:171-177. [PMID: 38957361 PMCID: PMC11215249 DOI: 10.4078/jrd.2024.0029] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/04/2024] [Revised: 04/09/2024] [Accepted: 04/17/2024] [Indexed: 07/04/2024]
Abstract
Objective The purpose of this study is to evaluate the impact of tumor necrosis factor (TNF)-α blocker therapy on the Assessment of SpondyloArthritis international Society Health Index (ASAS-HI) among patients who have failed conventional nonsteroidal anti-inflammatory drugs. Methods A comparative study was conducted involving axial spondyloarthritis (axSpA) patients treated with either TNF-α blocker or conventional therapy. Patient data, including demographics, disease characteristics, and ASAS-HI scores, were collected before and after treatment. Statistical analysis was performed to compare changes in ASAS-HI scores between the TNF-α blocker and the conventional therapy group. Results The study population consisted of patients with axSpA, with a mean age of 38.3 years in conventional treatment group and 29.3 years in TNF-α blocker group. Most variables, including C-reactive protein levels, other comorbidities, and disease assessment scores showed no significant difference between groups. Longitudinal analysis within each treatment group from Week 0 to 12 showed no significant change in the conventional treatment group, whereas the TNF-α blocker group experienced a significant reduction in ASAS-HI scores, demonstrating the effectiveness of the treatment. The TNF-α blocker group exhibited a significantly greater improvement in ASAS-HI scores compared to the conventional therapy group. The Bath Ankylosing Spondylitis Functional Index and the Bath Ankylosing Spondylitis Disease Activity Index demonstrated strong positive correlations with ASAS-HI scores, indicating higher disease activity and functional limitation are associated with worse health outcomes in patients. Conclusion The research demonstrates that ASAS-HI scores significantly improve with TNF-α blocker therapy in axSpA patients, underscoring ASAS-HI's effectiveness as a tool for evaluating drug responses.
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Affiliation(s)
- Ah-Ra Choi
- Department of Rheumatology, Chonnam National University Medical School and Hospital, Gwangju, Korea
- College of Nursing, Chonnam National University, Gwangju, Korea
| | - Ki-Jeong Park
- Department of Rheumatology, Chonnam National University Medical School and Hospital, Gwangju, Korea
| | - Ji-Hyoun Kang
- Department of Rheumatology, Chonnam National University Medical School and Hospital, Gwangju, Korea
| | - Yu Jeong Lee
- Department of Rheumatology, Chonnam National University Medical School and Hospital, Gwangju, Korea
- Department of Biomedical Sciences, Graduate School of Chonnam National University, Gwangju, Korea
| | - Hyun Hee Jang
- Department of Rheumatology, Chonnam National University Medical School and Hospital, Gwangju, Korea
| | - Moon-Ju Kim
- Department of Rheumatology, Chonnam National University Medical School and Hospital, Gwangju, Korea
| | - Tae-Jong Kim
- Department of Rheumatology, Chonnam National University Medical School and Hospital, Gwangju, Korea
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Yurdakul OV, Kara M, Ince B, Yildiz C, Yildiz T, Kilicoglu MS, Aydin T, Ozer OF. Raftlin - a potential biomarker for axial spondyloarthritis and psoriatic arthritis: An observational study. Medicine (Baltimore) 2024; 103:e38770. [PMID: 38941376 PMCID: PMC11466145 DOI: 10.1097/md.0000000000038770] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/18/2024] [Accepted: 06/10/2024] [Indexed: 06/30/2024] Open
Abstract
Our aim is to evaluate serum Raftlin levels as a biomarker for diagnosing and monitoring disease activity in patients with axial spondyloarthritis (axSpA) and Psoriatic arthritis (PsA). This trial included 40 axSpA patients, 40 PsA patients, and 40 healthy participants as the control group. Disease activity was assessed with Ankylosing Spondylitis Disease Activity Score for axSpA patients and The Disease Activity Index for Psoriatic Arthritis for PsA patients. The Spondyloarthritis Research Consortium of Canada index, health assessment questionnaire-disability index, and numeric rating scale were used to evaluate the enthesitis severity, disability, and pain status of all patients. Serum Raftlin levels were determined using the ELISA method. The 3 groups had no statistical differences regarding gender, age, weight, height, BMI, educational status, and exercise habits. The axSpA group had higher Raftlin levels than the PsA and control groups, and Raftlin levels were statistically significant in predicting the likelihood of axSpA. We found no statistically significant differences between the PsA and control groups. We found no statistically significant difference in Raftlin levels in HLA-B27 positive versus HLA-B27 negative patients in both axSpA and PsA groups. Our results also did not detect any correlation of Raftlin levels with Ankylosing Spondylitis Disease Activity Score, C-reactive protein, erythrocyte sedimentation rate, health assessment questionnaire-disability index, numeric rating scale, and Spondyloarthritis Research Consortium of Canada index in axSpA patients. Receiver operating characteristic analysis determined that Raftlin level ≥ 6.31 ng/mL discriminates axSpA from normal individuals with 92.5% sensitivity, 59% specificity, and an area under the curve of 0.738. Our results demonstrate that although serum Raftlin levels are elevated in axSpA patients, Raftlin cannot be used as an alone diagnostic marker for axSpA. Furthermore, it was not found to be related to the monitoring of disease activity, the level of pain, disability, or severity of enthesitis. This study is prospectively registered at www.clinicaltrials.gov (ID: NCT05771389).
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Affiliation(s)
- Ozan Volkan Yurdakul
- Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Bezmialem Vakif University, Istanbul, Turkey
| | - Mert Kara
- Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Bezmialem Vakif University, Istanbul, Turkey
| | - Bugra Ince
- Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Izmir City Hospital, University of Health Sciences, Izmir, Turkey
| | - Caner Yildiz
- Faculty of Medicine, Department of Medical Biochemistry, Bezmialem Vakif University, Istanbul, Turkey
| | - Tugce Yildiz
- Faculty of Medicine, Department of Medical Biochemistry, Bezmialem Vakif University, Istanbul, Turkey
| | - Mehmet Serkan Kilicoglu
- Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Bezmialem Vakif University, Istanbul, Turkey
| | - Teoman Aydin
- Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Bezmialem Vakif University, Istanbul, Turkey
| | - Omer Faruk Ozer
- Faculty of Medicine, Department of Medical Biochemistry, Bezmialem Vakif University, Istanbul, Turkey
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Daflaoui M, Azzouzi H, Boutaibi H, Chennouf F, Ichchou L. Association of trabecular bone score with disease parameters and vertebral fractures in axial spondyloarthritis. Rheumatol Adv Pract 2024; 8:rkae071. [PMID: 38855629 PMCID: PMC11157133 DOI: 10.1093/rap/rkae071] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/02/2024] [Accepted: 05/05/2024] [Indexed: 06/11/2024] Open
Abstract
Objectives We aimed to study trabecular bone score (TBS) association with disease parameters and vertebral fractures (VFs) in patients with axial spondyloarthritis. Methods Patients diagnosed with axial spondyloarthritis were included in this cross-sectional study. Dual-energy X-ray absorptiometry was used to measure BMD in the lumbar spine and TBS. Low TBS was defined as ≤1.31. The association between TBS and disease parameters including Ankylosing Spondylitis Disease Activity Score (ASDAS), BASDAI, BASFI and BASMI was studied using logistic regressions. Results Our study included 56 patients, with a mean age of 38.9 ± 13.5 years and a mean disease duration of 12.7 ± 7.7 years. Patients with low TBS were significantly older and had higher waist circumference and body mass index. These patients also showed greater clinical activity, as evidenced by higher ASDAS-CRP, BASFI and BASMI scores (P < 0.05). In multivariate logistic regression, low TBS was associated with all disease parameters, except for BASMI: BASDAI (OR [95% CI] = 3.68 [1.48-9.19], P = 0.005), ASDAS-CRP (OR [95% CI] = 2.92 [1.20-7.10], P = 0.018), BASFI (OR [95% CI] = 1.04 [1.01-1.08], P = 0.018), BASMI (OR [95% CI] = 1.36 [0.99-1.87], P = 0.062). However, no association was observed between TBS and VFs. Conclusion TBS was associated with active spondyloarthritis, suggesting increased bone fragility in these patients. However, TBS failed to demonstrate an association with VFs.
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Affiliation(s)
- Meryem Daflaoui
- Rheumatology Department, Mohammed VI University Hospital, Faculty of Medicine and Pharmacy, University Mohammed First, Oujda, Morocco
| | - Hamida Azzouzi
- Rheumatology Department, Mohammed VI University Hospital, Faculty of Medicine and Pharmacy, University Mohammed First, Oujda, Morocco
| | - Houssam Boutaibi
- Rheumatology Department, Mohammed VI University Hospital, Faculty of Medicine and Pharmacy, University Mohammed First, Oujda, Morocco
| | - Fadoua Chennouf
- Rheumatology Department, Mohammed VI University Hospital, Faculty of Medicine and Pharmacy, University Mohammed First, Oujda, Morocco
| | - Linda Ichchou
- Rheumatology Department, Mohammed VI University Hospital, Faculty of Medicine and Pharmacy, University Mohammed First, Oujda, Morocco
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Carbo M, Paap D, van Overbeeke L, Wink F, Bootsma H, Arends S, Spoorenberg A. Higher levels of physical activity are associated with less evasive coping, better physical function and quality of life in patients with axial spondyloarthritis. PLoS One 2024; 19:e0301965. [PMID: 38758932 PMCID: PMC11101074 DOI: 10.1371/journal.pone.0301965] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/09/2022] [Accepted: 03/26/2024] [Indexed: 05/19/2024] Open
Abstract
OBJECTIVE To evaluate daily physical activity (PA) in relation to psychosocial factors, such as anxiety, depression and different types of coping strategies, as well as patient- and disease-related factors in patients with axial spondyloarthritis (axSpA). METHODS Consecutive outpatients from the Groningen Leeuwarden AxSpA (GLAS) cohort completed the modified Short Questionnaire to assess health-enhancing PA (mSQUASH), Hospital Anxiety and Depression Scale (HADS) and Coping with Rheumatic Stressors (CORS) questionnaires, as well as standardized patient- and disease-related assessments. Univariable and multivariable linear regression analyses and comparison of lowest and highest PA tertiles were performed to explore associations between the HADS, CORS, patient- and disease-related factors and PA. RESULTS In total, 84 axSpA patients were included; 60% male, mean age 49 (SD ±14) years, median symptom duration 20 (25th-75th percentiles: 12-31) years, mean ASDAS 2.1 (±1.0). Higher PA levels were significantly associated with better scores on patient-reported disease activity (BASDAI), physical function (BASFI) and quality of life (ASQoL). Furthermore, higher levels of PA were associated with less impact of axSpA on wellbeing and lower HADS depression scores. In the multivariable linear regression model, less use of the coping strategy 'decreasing activities' (β: -376.4; p 0.003) and lower BMI (β:-235.5; p: 0.030) were independently associated with higher level of PA. Comparison of patients from the lowest and highest PA tertiles showed results similar to those found in the regression analyses. CONCLUSION In this cohort of axSpA patients, higher levels of daily PA were associated with better patient-reported outcomes and lower depression scores. Additionally, the passive coping strategy "decreasing activities" and lifestyle factor BMI were independently associated with PA. Besides anti-inflammatory treatment, coping strategies and lifestyle should be taken into account in the management of individual axSpA patients. Incorporating these aspects into patient education could increase patient awareness and self-efficacy. In the future, longitudinal studies are needed to better understand the complex relationship between patient-, disease- and psychosocial factors associated with daily PA.
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Affiliation(s)
- Marlies Carbo
- Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
| | - Davy Paap
- Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
- Department of Physical Therapy, Saxion, University of Applied Sciences, Enschede, The Netherlands
| | - Laura van Overbeeke
- Department of Human Movement Sciences, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
| | - Freke Wink
- Department of Rheumatology, Medical Center Leeuwarden, Leeuwarden, The Netherlands
| | - Hendrika Bootsma
- Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
| | - Suzanne Arends
- Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
| | - Anneke Spoorenberg
- Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
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Michielsens C, Bolhuis TE, van Gaalen FA, van den Hoogen F, Verhoef LM, den Broeder N, den Broeder AA. Construct validity of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) treatment target cut-offs in a BASDAI treat-to-target axial spondyloarthritis cohort: a cross-sectional study. Scand J Rheumatol 2024; 53:180-187. [PMID: 37339375 DOI: 10.1080/03009742.2023.2213509] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/30/2022] [Accepted: 05/10/2023] [Indexed: 06/22/2023]
Abstract
OBJECTIVE In axial spondyloarthritis (axSpA), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) are recommended for use in treat-to-target (T2T) strategies. However, BASDAI disease states may be a less suitable T2T instrument than ASDAS, since BASDAI contains non-disease activity related items. The objective of our study was to investigate the construct validity of BASDAI and ASDAS disease states. METHOD We performed a single-centre cross-sectional study on BASDAI and ASDAS construct validity in long-term BASDAI T2T-treated axSpA patients. Our hypothesis was that BASDAI is less representative of disease activity than ASDAS owing to the focus on pain and fatigue, and missing an objective item, e.g. C-reactive protein (CRP). This was operationalized using several subhypotheses. RESULTS The study included 242 axSpA patients. BASDAI and ASDAS disease states showed a similar relation to Patient Acceptable Symptom State and T2T protocol adherence. The proportions of patients with high BASDAI and ASDAS disease activity fulfilling Central Sensitization Inventory and fibromyalgia syndrome criteria were similar. The correlation with fatigue was moderate for both BASDAI (Spearman's rho 0.64) and ASDAS (Spearman's rho 0.54) disease states. A high ASDAS was strongly correlated with increased CRP (relative risk 6.02, 95% CI 3.0-12.09), while this correlation was not seen for BASDAI (relative risk 1.13, 95% CI 0.74-1.74). CONCLUSION Our study showed moderate and comparable construct validity for BASDAI- and ASDAS-based disease activity states, with the expected exception of association with CRP. Therefore, no strong preference can be given for either measure, although the ASDAS seems marginally more valid.
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Affiliation(s)
- Caj Michielsens
- Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands
- Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands
| | - T E Bolhuis
- Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands
- Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands
| | - F A van Gaalen
- Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands
| | - Fhj van den Hoogen
- Department of Rheumatic Diseases, Radboud University Medical Center, Nijmegen, the Netherlands
| | - L M Verhoef
- Department of Research and Innovation, Sint Maartenskliniek, Nijmegen, the Netherlands
| | - N den Broeder
- Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands
- Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands
| | - A A den Broeder
- Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands
- Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands
- Department of Rheumatic Diseases, Radboud University Medical Center, Nijmegen, the Netherlands
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Kulaksız B, Palamar D, Misirlioglu TO, Akgun K, Terlemez R. Ultrasonographic Evaluation of Nail Involvement in Patients With Axial Spondyloarthritis. JOURNAL OF ULTRASOUND IN MEDICINE : OFFICIAL JOURNAL OF THE AMERICAN INSTITUTE OF ULTRASOUND IN MEDICINE 2024; 43:967-978. [PMID: 38323351 DOI: 10.1002/jum.16426] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/07/2023] [Revised: 01/18/2024] [Accepted: 01/21/2024] [Indexed: 02/08/2024]
Abstract
OBJECTIVES This study aimed to evaluate the nail units of patients with axial spondyloarthritis (ax-SpA) using ultrasound and to identify any subclinical changes. We also aimed to examine the relationship between clinical enthesitis scores and nail involvement in patients with ax-SpA. METHODS The study included 40 patients with ax-Spa, 40 patients with psoriatic arthritis (PsA), and 40 healthy controls. The thickness of the nail plates, morphological changes, the thickness of the proximal nail units, the thickness of the nail beds, and power Doppler signal intensities were evaluated and compared. Maastricht Ankylosing Spondylitis Enthesitis Score and Spondyloarthritis Research Consortium of Canada Enthesitis Index were also evaluated in patients with ax-SpA. RESULTS There was no significant difference between the thickness of the nail plates of the three groups (P > .05). The first nail bed thickness of ax-SpA cases was significantly higher than the control group (P = .046), and the fourth and fifth nail proximal unit thicknesses of the control group were significantly lower than the ax-SpA and PsA groups (P = .023, P = .017). We also found that the Wortsman scores of the cases with PsA were significantly higher than the ax-SpA and control groups (P = .0001). CONCLUSION The thickness of the proximal nail unit adjacent to the insertion of the digital extensor tendon, which is considered as the enthesis area, is similar to the patients with PsA in patients with ax-SpA, especially in the fourth and fifth fingers compared to the control group. On the other hand, almost no structural changes in nail plates were observed in patients with ax-SpA group.
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Affiliation(s)
- Bilal Kulaksız
- Department of Physical Medicine and Rehabilitation, Cerrahpasa Medical Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey
| | - Deniz Palamar
- Department of Physical Medicine and Rehabilitation, Cerrahpasa Medical Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey
| | - Tugce Ozekli Misirlioglu
- Department of Physical Medicine and Rehabilitation, Cerrahpasa Medical Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey
| | - Kenan Akgun
- Department of Physical Medicine and Rehabilitation, Cerrahpasa Medical Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey
| | - Rana Terlemez
- Department of Physical Medicine and Rehabilitation, Cerrahpasa Medical Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey
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Lee S, Kang S, Kim H, Lee J, Kim MJ, Cha HS. Sex-specific disparities in disease activity scores among patients with axial spondyloarthritis and their implications for evaluating the response to tumor necrosis factor alpha inhibitor therapy. Arthritis Res Ther 2024; 26:90. [PMID: 38664785 PMCID: PMC11044537 DOI: 10.1186/s13075-024-03320-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/25/2024] [Accepted: 04/04/2024] [Indexed: 04/29/2024] Open
Abstract
BACKGROUND We aimed to investigate whether there are sex differences in disease activity measures among patients with axial spondyloarthritis (axSpA) and to determine any potential impact on the assessment of treatment responses to tumor necrosis factor alpha inhibitors (TNFi). METHODS Using the Korean College of Rheumatology Biologics and Targeted Therapy (KOBIO) registry data, we compared sex differences in changes in the Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) levels at baseline and one year after TNFi initiation in patients with axSpA. RESULTS This study included 1,753 patients with axSpA who started or changed TNFi, of whom 1,343 (76.6%) were male. At baseline, the mean BASDAI and ASDAS scores of all patients were 5.98 and 3.6, respectively. The BASDAI changes between baseline and the one-year follow-up were independently associated with sex (𝛽 = 0.343, p = 0.011), whereas ASDAS was not (𝛽 = 0.079, p = 0.235). When judging the effect of TNFi at one-year of treatment, male patients were more likely to be assessed as effective by the BASDAI-based criterion (ΔBASDAI ≥ 50% or ≥ 2; OR 1.700, 95% CI 1.200-2.406), while the ASDAS-based criterion (ΔASDAS ≥ 1.1) showed no significant difference between sexes (OR 0.993, 95% CI 0.678-1.455), after adjusting for other baseline characteristics. CONCLUSIONS The changes in disease activity before and after TNFi use were significantly different between sexes when measured by BASDAI, but not ASDAS. TNFi treatment effects may be interpreted differently between sexes depending on the disease activity measure used.
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Affiliation(s)
- Seulkee Lee
- Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea
| | - Seonyoung Kang
- Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea
| | - Hyungjin Kim
- Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea
| | - Jaejoon Lee
- Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea
| | - Min-Ji Kim
- Biomedical Statistics Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Republic of Korea
| | - Hoon-Suk Cha
- Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea.
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Wyatt NJ, Watson H, Anderson CA, Kennedy NA, Raine T, Ahmad T, Allerton D, Bardgett M, Clark E, Clewes D, Cotobal Martin C, Doona M, Doyle JA, Frith K, Hancock HC, Hart AL, Hildreth V, Irving PM, Iqbal S, Kennedy C, King A, Lawrence S, Lees CW, Lees R, Letchford L, Liddle T, Lindsay JO, Maier RH, Mansfield JC, Marchesi JR, McGregor N, McIntyre RE, Ostermayer J, Osunnuyi T, Powell N, Prescott NJ, Satsangi J, Sharma S, Shrestha T, Speight A, Strickland M, Wason JM, Whelan K, Wood R, Young GR, Zhang X, Parkes M, Stewart CJ, Jostins-Dean L, Lamb CA. Defining predictors of responsiveness to advanced therapies in Crohn's disease and ulcerative colitis: protocol for the IBD-RESPONSE and nested CD-metaRESPONSE prospective, multicentre, observational cohort study in precision medicine. BMJ Open 2024; 14:e073639. [PMID: 38631839 PMCID: PMC11029295 DOI: 10.1136/bmjopen-2023-073639] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/15/2023] [Accepted: 02/20/2024] [Indexed: 04/19/2024] Open
Abstract
INTRODUCTION Characterised by chronic inflammation of the gastrointestinal tract, inflammatory bowel disease (IBD) symptoms including diarrhoea, abdominal pain and fatigue can significantly impact patient's quality of life. Therapeutic developments in the last 20 years have revolutionised treatment. However, clinical trials and real-world data show primary non-response rates up to 40%. A significant challenge is an inability to predict which treatment will benefit individual patients.Current understanding of IBD pathogenesis implicates complex interactions between host genetics and the gut microbiome. Most cohorts studying the gut microbiota to date have been underpowered, examined single treatments and produced heterogeneous results. Lack of cross-treatment comparisons and well-powered independent replication cohorts hampers the ability to infer real-world utility of predictive signatures.IBD-RESPONSE will use multi-omic data to create a predictive tool for treatment response. Future patient benefit may include development of biomarker-based treatment stratification or manipulation of intestinal microbial targets. IBD-RESPONSE and downstream studies have the potential to improve quality of life, reduce patient risk and reduce expenditure on ineffective treatments. METHODS AND ANALYSIS This prospective, multicentre, observational study will identify and validate a predictive model for response to advanced IBD therapies, incorporating gut microbiome, metabolome, single-cell transcriptome, human genome, dietary and clinical data. 1325 participants commencing advanced therapies will be recruited from ~40 UK sites. Data will be collected at baseline, week 14 and week 54. The primary outcome is week 14 clinical response. Secondary outcomes include clinical remission, loss of response in week 14 responders, corticosteroid-free response/remission, time to treatment escalation and change in patient-reported outcome measures. ETHICS AND DISSEMINATION Ethical approval was obtained from the Wales Research Ethics Committee 5 (ref: 21/WA/0228). Recruitment is ongoing. Following study completion, results will be submitted for publication in peer-reviewed journals and presented at scientific meetings. Publications will be summarised at www.ibd-response.co.uk. TRIAL REGISTRATION NUMBER ISRCTN96296121.
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Affiliation(s)
- Nicola J Wyatt
- Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
- Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
| | - Hannah Watson
- Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
| | - Carl A Anderson
- Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, UK
| | - Nicholas A Kennedy
- Department of Gastroenterology, Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK
- Exeter Inflammatory Bowel Disease and Pharmacogenetics Research Group, University of Exeter, Exeter, UK
| | - Tim Raine
- Department of Gastroenterology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
| | - Tariq Ahmad
- Department of Gastroenterology, Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK
- Exeter Inflammatory Bowel Disease and Pharmacogenetics Research Group, University of Exeter, Exeter, UK
| | - Dean Allerton
- Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
| | - Michelle Bardgett
- Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
| | - Emma Clark
- Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
| | - Dawn Clewes
- Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
| | | | - Mary Doona
- Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
| | - Jennifer A Doyle
- Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
| | - Katherine Frith
- Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
| | - Helen C Hancock
- Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
| | - Ailsa L Hart
- Department of Gastroenterology, St Mark's Hospital and Academic Institute, London, UK
- Department of Surgery and Cancer, Imperial College London, London, UK
| | - Victoria Hildreth
- Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
| | - Peter M Irving
- Department of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust, London, UK
- School of Immunology & Microbial Sciences, King's College London, London, UK
| | - Sameena Iqbal
- Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, UK
| | - Ciara Kennedy
- Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
| | - Andrew King
- Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
| | - Sarah Lawrence
- Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
| | - Charlie W Lees
- Institute of Genetics & Molecular Medicine, University of Edinburgh, Edinburgh, UK
- Edinburgh IBD Unit, Western General Hospital, NHS Lothian, Edinburgh, UK
| | - Robert Lees
- Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
| | - Laura Letchford
- Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, UK
| | - Trevor Liddle
- Research Informatics Team, Clinical Research, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
| | - James O Lindsay
- Department of Gastroenterology, Barts Health NHS Trust, London, UK
- Centre for Immunobiology, Blizard Institute, Barts and the London School of Medicine, Queen Mary University of London, London, UK
| | - Rebecca H Maier
- Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
| | - John C Mansfield
- Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
- Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
| | - Julian R Marchesi
- Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, St Mary's Hospital, Imperial College London, London, UK
| | - Naomi McGregor
- Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
| | | | | | | | - Nick Powell
- Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, St Mary's Hospital, Imperial College London, London, UK
- Department of Gastroenterology, Imperial College Healthcare NHS Trust, London, UK
| | - Natalie J Prescott
- Department of Medical and Molecular Genetics, Guy's Hospital, King's College London, London, UK
| | - Jack Satsangi
- Nuffield Department of Medicine, University of Oxford, Oxford, UK
| | - Shriya Sharma
- Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
| | - Tara Shrestha
- Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
| | - Ally Speight
- Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
- Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
| | | | - James Ms Wason
- Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
| | - Kevin Whelan
- Department of Nutritional Sciences, King's College London, London, UK
| | - Ruth Wood
- Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK
| | - Gregory R Young
- Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
| | - Xinyue Zhang
- Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
| | - Miles Parkes
- Department of Gastroenterology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
| | - Christopher J Stewart
- Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
| | | | - Christopher A Lamb
- Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
- Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
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50
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Navarro-Compán V, Ramiro S, Deodhar A, Mease PJ, Rudwaleit M, de la Loge C, Fleurinck C, Taieb V, Mørup MF, Massow U, Kay J, Magrey M. Association of clinical response criteria and disease activity levels with axial spondyloarthritis core domains: results from two phase 3 randomised studies, BE MOBILE 1 and 2. RMD Open 2024; 10:e004040. [PMID: 38599650 PMCID: PMC11015249 DOI: 10.1136/rmdopen-2023-004040] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/02/2024] [Accepted: 03/25/2024] [Indexed: 04/12/2024] Open
Abstract
OBJECTIVE To assess how achievement of increasingly stringent clinical response criteria and disease activity states at week 52 translate into changes in core domains in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA). METHODS Patients in BE MOBILE 1 and 2 achieving different levels of response or disease activity (Assessment of SpondyloArthritis International Society (ASAS) and Ankylosing Spondylitis Disease Activity Score (ASDAS) response criteria, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50)) at week 52 were pooled, regardless of treatment arm. Associations between achievement of these endpoints and change from baseline (CfB) in patient-reported outcomes (PROs) measuring core axSpA domains, including pain, fatigue, physical function, overall functioning and health, and work and employment, were assessed. RESULTS Achievement of increasingly stringent clinical efficacy endpoints at week 52 was generally associated with sequentially greater improvements from baseline in all PROs. Patients with nr-axSpA achieving ASAS40 demonstrated greater improvements (CfB) than patients who did not achieve ASAS40 but did achieve ASAS20, in total spinal pain (-5.3 vs -2.8, respectively), Functional Assessment of Chronic Illness-Fatigue subscale (12.7 vs 6.7), Bath Ankylosing Spondylitis Function Index (-3.9 vs -1.8), European Quality of Life 5-Dimension 3-Level Version (0.30 vs 0.16), Work Productivity and Activity Impairment-axSpA presenteeism (-35.4 vs -15.9), overall work impairment (-36.5 vs -12.9), activity impairment (-39.0 vs -21.0) and sleep (9.0 vs 3.9). Results were similar for ASDAS and BASDAI50. Similar amplitudes of improvement were observed between patients with nr-axSpA and r-axSpA. CONCLUSIONS Patients treated with bimekizumab across the full axSpA disease spectrum, who achieved increasingly stringent clinical response criteria and lower disease activity at week 52, reported larger improvements in core axSpA domains.
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Affiliation(s)
| | - Sofia Ramiro
- Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands
- Department of Rheumatology, Zuyderland Medical Centre Heerlen, Heerlen, Netherlands
| | - Atul Deodhar
- Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA
| | - Philip J Mease
- School of Medicine, Swedish Medical Center and University, Seattle, Washington, USA
| | - Martin Rudwaleit
- Internal Medicine and Rheumatology, Klinikum Bielefeld Rosenhöhe, Bielefeld, Germany
| | | | | | | | | | | | - Jonathan Kay
- Division of Rheumatology, Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA
| | - Marina Magrey
- Case Western Reserve University, Cleveland, Ohio, USA
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