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Uslu S, Gülle S, Urak Ö, Şen G, Dalkılıç E, Şenel S, Akar S, İnanç N, Cefle A, Köken Avşar A, Yolbaş S, Yılmaz S, Soysal Gündüz Ö, Sarı İ, Birlik M, Akkoç N, Önen F. Biological treatment in elderly and young patients with ankylosing spondylitis: TURKBIO real-life data results. Arch Rheumatol 2024; 39:232-241. [PMID: 38933720 PMCID: PMC11196228 DOI: 10.46497/archrheumatol.2024.10391] [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: 06/17/2023] [Accepted: 11/02/2023] [Indexed: 06/28/2024] Open
Abstract
Objectives This study aims to investigate the effect of age on disease activity and biological treatment in patients with ankylosing spondylitis (AS). Patients and methods A total of 811 AS patients registered in the TURKBIO registry database between 2011 and 2019 were categorized according to their age at the time of entry into the registry and assigned to one of two groups: young patients, defined as <60 years of age (n=610), and those aged ≥60 years (n=201) were recorded as elderly patients. Demographic, clinical, and laboratory characteristics, along with disease activity markers and other follow-up parameters, as well as current and prior treatments, were electronically recorded during each visit using open-source software. Results The mean age of the elderly patients was 67±5.8 years, while the mean age of the younger patients was 49.2±10.9 years. Male predominance was lower in the older AS group compared to the younger AS group (p=0.002). During follow-up period, 397 patients (comprising 318 young and 79 elderly individuals) had a history of using at least one biological disease-modifying agent (bDMARD). There was no significant difference between the groups in terms of DMARD and bDMARD-use distributions. First tumor necrosis factor inhibitor (TNFi) retention rates were found to be similar in both groups over 10 years of follow-up. Adverse events were found to be similar in young (19.9%) and elderly (26.8%) AS patients. Conclusion Research in the TURKBIO cohort reveals that both older and younger patients with AS exhibited similar disease activity levels with comparable treatment approaches. Moreover, the results of TNFi treatments in elderly patients were the same as those observed in younger patients, with no notable increase in safety concerns.
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Affiliation(s)
- Sadettin Uslu
- Department of Internal Medicine, Division of Rheumatology, Celal Bayar University Faculty of Medicine, Manisa, Türkiye
| | - Semih Gülle
- Department of Internal Medicine, Division of Rheumatology, Dokuz Eylül University Faculty of Medicine, Izmir, Türkiye
| | - Özkan Urak
- Department of Internal Medicine, Division of Rheumatology, Dokuz Eylül University Faculty of Medicine, Izmir, Türkiye
| | - Gerçek Şen
- Department of Internal Medicine, Division of Rheumatology, Dokuz Eylül University Faculty of Medicine, Izmir, Türkiye
| | - Ediz Dalkılıç
- Department of Internal Medicine, Division of Rheumatology, Uludağ University Faculty of Medicine, Bursa, Türkiye
| | - Soner Şenel
- Department of Internal Medicine, Division of Rheumatology, Erciyes University Faculty of Medicine, Kayseri, Türkiye
| | - Servet Akar
- Department of Internal Medicine, Division of Rheumatology, Katip Çelebi University Faculty of Medicine, Izmir, Türkiye
| | - Nevsun İnanç
- Department of Internal Medicine, Division of Rheumatology, Marmara University Faculty of Medicine, Istanbul, Türkiye
| | - Ayşe Cefle
- Department of Internal Medicine, Division of Rheumatology, Kocaeli University Faculty of Medicine, Kocaeli, Türkiye
| | - Aydan Köken Avşar
- Department of Internal Medicine, Division of Rheumatology, Kocaeli City Hospital, Kocaeli, Türkiye
| | - Servet Yolbaş
- Department of Internal Medicine, Division of Rheumatology, İnönü University Faculty of Medicine, Malatya, Türkiye
| | - Sema Yılmaz
- Department of Internal Medicine, Division of Rheumatology, Selçuk University Faculty of Medicine, Konya, Türkiye
| | - Özgül Soysal Gündüz
- Department of Internal Medicine, Division of Rheumatology, Celal Bayar University Faculty of Medicine, Manisa, Türkiye
| | - İsmail Sarı
- Department of Internal Medicine, Division of Rheumatology, Dokuz Eylül University Faculty of Medicine, Izmir, Türkiye
| | - Merih Birlik
- Department of Internal Medicine, Division of Rheumatology, Dokuz Eylül University Faculty of Medicine, Izmir, Türkiye
| | - Nurullah Akkoç
- Department of Internal Medicine, Division of Rheumatology, Celal Bayar University Faculty of Medicine, Manisa, Türkiye
| | - Fatoş Önen
- Department of Internal Medicine, Division of Rheumatology, Dokuz Eylül University Faculty of Medicine, Izmir, Türkiye
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Srinivasan AR. Treat to target in Crohn's disease: A practical guide for clinicians. World J Gastroenterol 2024; 30:50-69. [PMID: 38293329 PMCID: PMC10823901 DOI: 10.3748/wjg.v30.i1.50] [Citation(s) in RCA: 11] [Impact Index Per Article: 11.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/10/2023] [Revised: 11/23/2023] [Accepted: 12/21/2023] [Indexed: 01/06/2024] Open
Abstract
A treat-to-target (T2T) approach applies the principles of early intervention and tight disease control to optimise long-term outcomes in Crohn's disease. The Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE)-II guidelines specify short, intermediate, and long-term treatment goals, documenting specific treatment targets to be achieved at each of these timepoints. Scheduled appraisal of Crohn's disease activity against pre-defined treatment targets at these timepoints remains central to determining whether current therapy should be continued or modified. Consensus treatment targets in Crohn's disease comprise combination clinical and patient-reported outcome remission, in conjunction with biomarker normalisation and endoscopic healing. Although the STRIDE-II guidelines endorse the pursuit of endoscopic healing, clinicians must consider that this may not always be appropriate, acceptable, or achievable in all patients. This underscores the need to engage patients at the outset in an effort to personalise care and individualise treatment targets. The use of non-invasive biomarkers such as faecal calprotectin in conjunction with cross-sectional imaging techniques, particularly intestinal ultrasound, holds great promise; as do emerging treatment targets such as transmural healing. Two randomised clinical trials, namely, CALM and STARDUST, have evaluated the efficacy of a T2T approach in achieving endoscopic endpoints in patients with Crohn's disease. Findings from these studies reflect that patient subgroups and Crohn's disease characteristics likely to benefit most from a T2T approach, remain to be clarified. Moreover, outside of clinical trials, data pertaining to the real-world effectiveness of a T2T approach remains scare, highlighting the need for pragmatic real-world studies. Despite the obvious promise of a T2T approach, a lack of guidance to support its integration into real-world clinical practice has the potential to limit its uptake. This highlights the need to describe strategies, processes, and models of care capable of supporting the integration and execution of a T2T approach in real-world clinical practice. Hence, this review seeks to examine the current and emerging literature to provide clinicians with practical guidance on how to incorporate the principles of T2T into routine clinical practice for the management of Crohn's disease.
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Affiliation(s)
- Ashish R Srinivasan
- Department of Gastroenterology, Austin Health, Victoria, Melbourne 3083, Australia
- Department of Gastroenterology, Eastern Health, Victoria, Melbourne 3128, Australia
- Department of Medicine, University of Melbourne, Victoria, Melbourne 3052, Australia
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Felten R, Toussirot E. Current Pharmacological Therapies for the Management of Spondyloarthritis: Special Considerations in Older Patients. Drugs Aging 2023; 40:1101-1112. [PMID: 37902947 DOI: 10.1007/s40266-023-01073-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 09/26/2023] [Indexed: 11/01/2023]
Abstract
Spondylarthritis (SpA) is generally observed in young male patients but can be diagnosed in older patients. These cases correspond to late-onset SpA (LoSpA) with two main clinical presentations, axial and peripheral SpA. Another increasingly common situation is that of older patients who have had SpA for many years. The therapeutic management of LoSpA is quite smilar to the management of patients with an early-onset disease, combining both non-pharmacological and pharmacological treatments. The treatments that can be used in LoSpA include non-steroidal anti-inflammatory drugs (NSAIDs) and biological agents targeting TNFα or IL-17A. Janus kinase inhibitors (JAKi) were recently introduced on the market for SpA. TNF inhibitors and IL-17inhibitors are very effective drugs in early-onset SpA. The effectiveness and safety of targeted therapies have not been specifically evaluated in LoSpA or older patients, and thus caution is required for these patients with comorbidities and/or polymedication. According to indirect data, biological agents seem to be less effective in LoSpA compared with early-onset disease. In parallel, a careful evaluation for the risk of infection, malignancy and cardiovascular events is recommended before initiating these drugs in this age category. JAKi may be used in LoSpA, but only in selected patients according to recent recommendations from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). When considering that the prevalence of such situations is expected to increase as ageing progresses, it is certainly time to consider this patient category as a distinct subgroup within the spectrum of SpA. Specific studies evaluating targeted agents in this age category are thus desirable.
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Affiliation(s)
- Renaud Felten
- Centre d'Investigation Clinique, INSERM CIC-1434, Hôpitaux Universitaires de Strasbourg, Strasbourg, France
- Service de Rhumatologie, Centre National de Référence des Maladies Autoimmunes (RESO), Hôpitaux Universitaires de Strasbourg, Strasbourg, France
- Département Universitaire de Pharmacologie-Addictologie, Toxicologie et Thérapeutique, Université de Strasbourg, Strasbourg, France
| | - Eric Toussirot
- Département Universitaire de Thérapeutique, CHU de Besançon, INSERM CIC-1431, Rhumatologie, INSERM UMR 1098 Right, Université de Franche-Comté, 25000, Besançon, France.
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Demirkan FG, Sönmez HE, Lamot L, Akgün Ö, Sözeri B, Ayaz NA. Embracing Change: An International Survey Study on the Beliefs and Attitudes of Pediatric Rheumatologists Towards Biosimilars. BioDrugs 2022; 36:421-430. [PMID: 35380389 DOI: 10.1007/s40259-022-00526-w] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 03/01/2022] [Indexed: 11/02/2022]
Abstract
BACKGROUND Biosimilars have been adopted by clinicians more slowly than anticipated in the post-marketing phase. OBJECTIVES We aimed to reveal the perceptions and attitudes of pediatric rheumatologists towards biosimilars and the obstacles to biosimilar therapy. METHODS A web-based survey designed to determine the knowledge, experience, and perceptions of pediatric rheumatologists about biosimilars was electronically mailed to the participants between April and August 2021. Responses were collected anonymously and subsequently analyzed. RESULTS A total of 114 pediatric rheumatologists including fellows (32.4%), specialists (29.8%), and seniors (37.7%) responded to the questionnaire. According to the data, 75 (65.8%) physicians had already prescribed at least one biosimilar. The vast majority of participants were aware of the potential cost savings of biosimilars (84, 73.3%). Participants who felt insufficiently informed were 41.8%, 67.6%, and 83.7% among seniors, specialists, and fellows, respectively. In pediatric rheumatology, the scarcity of clinical trials and real-life data (64%) and inadequate information about tolerance to the biosimilars and related side effects in children (49.1%) were the most common barriers expressed by prescribers. Nearly half (45%) of the pediatric rheumatologists preferred to prescribe biosimilars in the treatment of biologic-naive cases. However, most (93%) were reluctant to switch a reference molecule to a biosimilar while the patient was doing well under the originator medicine. CONCLUSIONS This survey provided insights into the concerns about prescribing biosimilars among pediatric rheumatologists. In the field of pediatric rheumatology, further education about biosimilars and real-life experiences is required to better inform about treatment options in children.
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Affiliation(s)
- Fatma Gül Demirkan
- Department of Pediatric Rheumatology, İstanbul University, İstanbul School of Medicine, Istanbul, Turkey
| | - Hafize Emine Sönmez
- Department of Pediatric Rheumatology, Kocaeli University, Kocaeli School of Medicine, Kocaeli, Turkey
| | - Lovro Lamot
- Department of Pediatrics, University Hospital Center, Zagreb, University of Zagreb School of Medicine, Zagreb, Croatia
| | - Özlem Akgün
- Department of Pediatric Rheumatology, İstanbul University, İstanbul School of Medicine, Istanbul, Turkey
| | - Betül Sözeri
- Department of Pediatric Rheumatology, University of Health Sciences, Ümraniye Research and Training Hospital, Istanbul, Turkey
| | - Nuray Aktay Ayaz
- Department of Pediatric Rheumatology, İstanbul University, İstanbul School of Medicine, Istanbul, Turkey.
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Challenges in the management of older patients with inflammatory rheumatic diseases. Nat Rev Rheumatol 2022; 18:326-334. [PMID: 35314796 DOI: 10.1038/s41584-022-00768-6] [Citation(s) in RCA: 36] [Impact Index Per Article: 12.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/23/2022] [Indexed: 12/20/2022]
Abstract
The rise in the number of people aged 65 years and older living with inflammatory rheumatic diseases such as rheumatoid arthritis is causing considerable challenges for clinicians. As patients get older, they are at an increased risk of multiple chronic diseases, a situation termed multimorbidity. Multimorbidity inevitably drives polypharmacy, where by a patient requires treatment with multiple medications. In addition, advancing age, multimorbidity and polypharmacy all place a patient at an increased risk of developing geriatric syndromes, which are clinical conditions in older people that do not fit into disease categories and include malnutrition, sarcopenia and frailty. Geriatric syndromes further increase the risk of adverse outcomes, including the accrual of additional morbidity, nursing home admission and mortality. Patients with inflammatory rheumatic diseases are especially prone to developing geriatric syndromes. Some predisposing risk factors for geriatric syndromes, such as joint swelling and functional limitations, are also inherent to rheumatic inflammatory disease itself. The frequent coexistence of multimorbidity, polypharmacy and geriatric syndromes in this patient group requires individually tailored interventions to preserve patient independence and overall functioning. To prepare for the changing demography, rheumatologists should gain more insight into the implications of multimorbidity, polypharmacy and geriatric syndromes for the management of older patients with inflammatory rheumatic diseases.
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Kim SH, Kim HR, Lee SH, Shin K, Kim HA, Min HK. Effectiveness and drug retention of biologic disease modifying antirheumatic drugs in Korean patients with late onset ankylosing spondylitis. Sci Rep 2021; 11:21555. [PMID: 34732807 PMCID: PMC8566570 DOI: 10.1038/s41598-021-01132-6] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/21/2021] [Accepted: 10/20/2021] [Indexed: 12/15/2022] Open
Abstract
The clinical data on the biologic disease-modifying antirheumatic drug (bDMARD) use in late-onset ankylosing spondylitis (LOAS) is limited. Thus, this study aimed to evaluate the drug efficacy and retention rate of bDMARDs in LOAS and compare it to young-onset ankylosing spondylitis (YOAS). Data of patients with AS receiving bDMARDs were extracted from the Korean College of Rheumatology Biologics and Targeted Therapy registry. Patients whose age of onset was > 50 years and ≤ 50 years were classified as having LOAS and YOAS, respectively. Their baseline characteristics and disease-associated parameters were evaluated. Drug efficacy [Ankylosing Spondylitis Disease Activity Score (ASDAS)-clinically important improvement (CII), ASDAS-major improvement (MI), Assessment of SpondyloArthritis International Society (ASAS) 20, and ASAS 40] at 1-year follow-up and drug retention rates were assessed. A total of 1708 patients (comprising 1472 patients with YOAS and 236 patients with LOAS) were included in this analysis. The LOAS group had a lower prevalence among males, lower HLA-B27 positivity and a higher prevalence of peripheral arthritis. Patients with LOAS were more likely to have higher disease-associated parameters (inflammatory reactants, patient global assessment, ASDAS-erythrocyte sedimentation rate, and ASDAS-C-reactive protein). LOAS was negatively associated with achieving ASDAS-CII, ASAS 20, and ASAS 40. The drug retention rate was lower in LOAS; however, the propensity score-matched and covariate-adjusted hazard ratios for bDMARD discontinuation were comparable to YOAS. There were no differences in the drug retention rates based on the type of bDMARD used in LOAS. Inferior clinical efficacy and shorter drug retention time were found in patients with LOAS receiving bDMARDs using real-world nationwide data. There were no differences among each bDMARD type.
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Affiliation(s)
- Se Hee Kim
- Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center, 120-1 Neungdong-ro (Hwayang-dong), Gwangjin-gu, Seoul, 05029, Republic of Korea
| | - Hae-Rim Kim
- Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Republic of Korea
| | - Sang-Heon Lee
- Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Republic of Korea
| | - Kichul Shin
- Division of Rheumatology, Department of Internal Medicine, Seoul Metropolitan Government - Seoul National University Boramae Medical Center, Seoul, Korea
| | - Hyoun-Ah Kim
- Department of Rheumatology, Ajou University School of Medicine, Suwon, Korea
| | - Hong Ki Min
- Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center, 120-1 Neungdong-ro (Hwayang-dong), Gwangjin-gu, Seoul, 05029, Republic of Korea.
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Ruggiero A, Fabbrocini G, Cinelli E, Ocampo Garza SS, Camela E, Megna M. Anti-interleukin-23 for psoriasis in elderly patients: guselkumab, risankizumab and tildrakizumab in real-world practice. Clin Exp Dermatol 2021; 47:561-567. [PMID: 34642965 PMCID: PMC9299162 DOI: 10.1111/ced.14979] [Citation(s) in RCA: 64] [Impact Index Per Article: 16.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/27/2021] [Accepted: 10/11/2021] [Indexed: 12/15/2022]
Abstract
Background Elderly patients (aged ≥ 65 years) represent an increasing proportion of patients with psoriasis and 15% of these have moderate to severe disease. Biologics are being used frequently in this group of patients even though safety and efficacy data are limited. In addition, owing to anti‐interleukin (IL)‐23 therapies being a relatively recent option, no data have been reported about their use in elderly patients with psoriasis. Aim To evaluate and compare the safety and efficacy of guselkumab, risankizumab and tildrakizumab in real‐world practice in elderly patients. Methods This was a single‐centre retrospective study that enrolled patients aged ≥ 65 years with moderate to severe plaque psoriasis, treated with guselkumab, risankizumab or tildrakizumab. The length of the study for each group depended on the drug (44 weeks for risankisumab, 40 weeks for guselkumab and 28 weeks for tildrakizumab, owing to its more recent availability in Italy). Results In total, 34 patients were enrolled (n = 20 on guselkumab; n = 8 on risankizumab; n = 6 on tildrakizumab). At Week 4, 29.4% reached 90% improvement in Psoriasis Area and Severity Index (PASI90) and 8.8% reached 100% improvement in PASI (PASI100); at Week 28, PASI90 and PASI100 was reached by 58.8% and 29.4%, respectively. At the final follow‐up (Week 40 or 44, depending on drug), data were available only for the risankizumab (Week 40) and guselkumab (Week 44) and groups, and showed that 71.4% of patients had reached PASI90 and 53.5% had reached PASI100. Four patients (11.7%) discontinued treatment. No significant differences were found between the three groups. The limitations of the study included its retrospective nature of the study, small sample size, and different numbers of patients and follow‐up duration for the different groups (highest for guselkumab, lowest for tildrakizumab). Conclusion The three anti‐IL‐23 therapies assessed are promising, safe and effective options in elderly patients, and there was no significant difference between them. However, more data are needed to confirm our results and to understand their role in the management of this group of patients.
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Affiliation(s)
- A Ruggiero
- Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
| | - G Fabbrocini
- Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
| | - E Cinelli
- Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
| | - S S Ocampo Garza
- Department of Dermatology, University Hospital Dr José Eleuterio González, Universidad Autónoma de Nuevo León, Monterrey, Mexico
| | - E Camela
- Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
| | - M Megna
- Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
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Cognitive impairment in elderly patients with rheumatic disease and the effect of disease-modifying anti-rheumatic drugs. Clin Rheumatol 2020; 40:1221-1231. [PMID: 32862311 DOI: 10.1007/s10067-020-05372-1] [Citation(s) in RCA: 21] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/26/2020] [Revised: 08/17/2020] [Accepted: 08/25/2020] [Indexed: 12/11/2022]
Abstract
Recent development of biologic disease-modifying anti-rheumatic drugs (DMARDs) has led to better control of disease activity among patients with chronic rheumatological diseases. Many patients with rheumatic disease are living longer, adding to the growing elderly population. Rheumatic diseases, most notably rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE), are known to increase the risk of cognitive impairment. Systemic inflammation associated with chronic rheumatological diseases has been postulated to be key driver of cognitive decline. Recent development of classic and biologic DMARDs have led to better control of disease activity among patients with rheumatic conditions. It is proposed that strict control of systemic inflammation will significantly lower the risk of cognitive impairment among patients with rheumatic disease. The impact of classic DMARDs on cognitive function appears to be variable. On the other hand, biologic DMARDs, specifically antitumor necrosis factor (TNF) drugs (i.e., etanercept), have been shown to significantly lower the risk of dementia. Experimental studies on IL-1, IL-6, and B and T cell blockade are promising. However, clinical data is limited. Preclinical studies on targeted therapies, specifically JAK/STAT inhibitors, also show promising results. Additional studies are necessary to better understand the impact of these newer biologic agents on cognitive function in elderly patients with rheumatic disease. Key points • Patients with chronic rheumatic conditions are beginning to live longer, adding to the elderly population. • Patients with chronic rheumatologic disease are at increased risk of cognitive impairment compared to the general population. • Recent development of biologic (i.e., TNF, IL-1, IL-6) and targeted drugs (i.e., Janus kinase inhibitors) have led to better control of disease activity. • Current evidence suggests that TNF inhibitors may have beneficial effects on cognitive function. However, evidence on newer biologic and targeted therapies is limited.
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Michaut A, Varin S. [Biotherapies in elderly patients]. Rev Med Interne 2020; 41:591-597. [PMID: 32674900 DOI: 10.1016/j.revmed.2020.04.011] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/17/2019] [Revised: 03/27/2020] [Accepted: 04/09/2020] [Indexed: 11/29/2022]
Abstract
The ageing of the population leads health professionals to question the tolerance and the effectiveness of the different biotherapies used in autoimmune diseases. Due to the exponential increase of biotherapies and their indications, several studies have been carried out to evaluate their impact on elderly patients suffering from autoimmune disease. However, these studies are still too few to take into account all the different specificities of elderly patients and their comorbidities; prescribers are therefore hesitant with their introduction after 75 years or even 65. More than the age of patients, it is necessary to evaluate the comorbidities before introducing this kind of treatments. Every biotherapy has different indications and contraindications, which must be known to adapt each treatment to each patient. This focus aims to remind of the adaptations and contraindications of the different biological disease-modifying anti-rheumatic drugs for geriatric population, and improve their uses since the treatments for these patients are sometimes not enough. Here we resume the methods allowing supervisors to identify errors of clinical reasoning in medical students and interns and we explain remediation techniques adapted to the types of error identified. Access to short illustrative videos of a MOOC (Massive Open On line Course) devoted to the supervision of clinical reasoning constitutes practical help for supervisors who are not expert in the complexity of medical pedagogy at the bedside.
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Affiliation(s)
- A Michaut
- Service de Rhumatologie, Centre Hospitalier Départemental de Vendée, Boulevard Stéphane Moreau, 85000 La Roche-sur-Yon, France.
| | - S Varin
- Service de Rhumatologie, Centre Hospitalier Départemental de Vendée, Boulevard Stéphane Moreau, 85000 La Roche-sur-Yon, France
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Moll-Udina A, Miguel Escuder L, Hernanz I, Llorenç V, Fonollosa A, Cordero Coma M, Sainz de la Maza M, Espinosa G, González Guijarro JJ, Lopez Lopez F, Alba-Linero C, Hernández M, Martínez Costa L, Celdrán Vivancos D, Giralt L, Artaraz J, Soler Bartrina P, Jódar Márquez M, García de Vicuña R, Esquinas C, Adán A. Adalimumab in Elderly Patients with Non-Infectious Uveitis. Safety and Efficacy. Ocul Immunol Inflamm 2020; 29:1591-1598. [PMID: 32657649 DOI: 10.1080/09273948.2020.1769139] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/23/2022]
Abstract
PURPOSE To assess the efficacy and safety of adalimumab in elderly patients with noninfectious uveitis (NIU). METHODS An observational, retrospective, multicenter study was done. Changes in best-corrected visual acuity (BCVA), inflammatory activity parameters, central retinal thickness (CRT), and the occurrence of adverse events (AE) developed during follow-up were recorded. RESULTS A total of 82 eyes from 41 patients 60 years of age and older with noninfectious uveitis treated with adalimumab were included. A significant improvement in BCVA (71.5 to 75.4 letters, p = .001) and in CRT (311.1 μm to 265 μm, p = .001) was observed. Moreover, a significant decrease from baseline in the rate of patients with anterior chamber cell (ACC) >0+ (34.6% to 5.7%, p = <0.001) or vitreous haze>0+ (21.3% to 4.3%, p = .002) was determined. AEs were observed in 11 patients (26.8%). CONCLUSION Adalimumab can be safe and efficacious for the treatment of NIU in patients 60 years of age and older.
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Affiliation(s)
- Aina Moll-Udina
- Department of Ophthalmology, Ophthalmology Clinic Institute, Hospital Clinic, University of Barcelona, Barcelona, Spain
| | - Lucía Miguel Escuder
- Department of Ophthalmology, Ophthalmology Clinic Institute, Hospital Clinic, University of Barcelona, Barcelona, Spain
| | - Inés Hernanz
- Department of Ophthalmology, Ophthalmology Clinic Institute, Hospital Clinic, University of Barcelona, Barcelona, Spain
| | - Victor Llorenç
- Department of Ophthalmology, Ophthalmology Clinic Institute, Hospital Clinic, University of Barcelona, Barcelona, Spain
| | - Alex Fonollosa
- Department of Ophthalmology, BioCruces Health Research Institute, Cruces Hospital, University of Basque Country, Leioa, Spain
| | - Miguel Cordero Coma
- Department of Ophthalmology, University Hospital of León, IBIOMED, University of León, León, Spain
| | - Maite Sainz de la Maza
- Department of Ophthalmology, Ophthalmology Clinic Institute, Hospital Clinic, University of Barcelona, Barcelona, Spain
| | - Gerard Espinosa
- Department of Autoimmune Diseases, Hospital Clinic, University of Barcelona, Barcelona, Spain
| | | | | | - Carmen Alba-Linero
- Department of Ophthalmology, Regional University Hospital of Málaga, University of Malaga, Málaga, Spain
| | - Marisa Hernández
- Department of Ophthalmology, General Hospital of Valencia, Valencia, Spain
| | | | | | - Lena Giralt
- Department of Ophthalmology, BioCruces Health Research Institute, Cruces Hospital, University of Basque Country, Leioa, Spain
| | - Joseba Artaraz
- Department of Ophthalmology, BioCruces Health Research Institute, Cruces Hospital, University of Basque Country, Leioa, Spain
| | | | - Margarita Jódar Márquez
- Department of Ophthalmology, Regional University Hospital of Málaga, University of Malaga, Málaga, Spain
| | | | - Cristina Esquinas
- Vall Hebron Research Institute, Autonomous University of Barcelona, Barcelona, Spain
| | - Alfredo Adán
- Department of Ophthalmology, Ophthalmology Clinic Institute, Hospital Clinic, University of Barcelona, Barcelona, Spain
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Abstract
Elderly patients are the main users of drugs and they differ from younger patients. They are a heterogeneous population that cannot be defined only by age but should rather be stratified based on their frailty. The elderly have distinctive pharmacokinetic and pharmacodynamic characteristics, are frequently polymorbid, and are therefore treated with multiple drugs. They may experience adverse reactions that are difficult to recognize, since some of them present non-specific symptoms easily mistaken for geriatric conditions. Paradoxically, the elderly are underrepresented in clinical trials, especially the frail individuals whose pharmacological response and expected treatment outcome can be different from those of non-frail patients. This means that the benefit-risk balance of drugs used in frail elderly patients is frequently unknown. We present some proposals to overcome the barriers preventing the enrollment of frail elderly patients in clinical trials, and strategies for monitoring their therapy to minimize the risk of adverse reactions. Automated alerts for drug and drug-disease interactions could help appropriate prescribing but should flag only clinically relevant interactions. Pharmaceutical forms should be designed to allow easy dose adjustment and, together with packaging and labeling, should account for the physical and cognitive limitations of frail elderly patients. Aggregate pharmacovigilance reports should summarize the safety profile in the elderly, but rather than presenting the results by age they should focus on patients' frailty, perhaps using the number of comorbidities as a proxy when information on frailty is not available.
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Akter R, Maksymowych WP, Martin ML, Hogan DB. Outcomes with Biological Disease-Modifying Anti-Rheumatic Drugs (bDMARDs) in Older Patients Treated for Rheumatoid Arthritis. Can Geriatr J 2020; 23:184-189. [PMID: 32494334 PMCID: PMC7259924 DOI: 10.5770/cgj.23.393] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023] Open
Abstract
BACKGROUND Biological disease-modifying antirheumatic drugs (bDMARDs) are recommended for rheumatoid arthritis (RA), but older patients reportedly experience more adverse events (AEs) and show variable treatment response. The objective of this study was to evaluate AEs and effectiveness of bDMARDs in a cohort of older patients. METHODS AE and treatment effectiveness (based on DAS28 scores) data from a prospective provincial pharmacovigilance program for the years 2006-2009 in patients 55-64, 65-74, and 75+ years of age were compared. An intention to treat analysis with chi-square and unpaired t-testing for significance was performed. RESULTS There were a total of 333 patients (156 were aged 55-64, 125 were 65-74, 52 were 75+). Those 75+ had higher disease activity and worse functional status at baseline. Among those 75+, AEs with bDMARDs were more common and likely to lead to discontinuation of therapy, be graded as severe, and classified as infectious (p < .05). Remission rate among those 75+ was significantly higher than patients 65-74. Etanercept was the most commonly used drug in all age groups. CONCLUSION Patients 75+ treated with bDMARDs are at a significantly greater risk of AEs, including infectious ones. The higher remission found in the oldest age group warrants further study.
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Affiliation(s)
- Ripa Akter
- Geriatrics, Internal Medicine, Division of Geriatric Medicine, University of Ottawa, Ottawa, ON, Canada
| | - Walter P. Maksymowych
- Division of Rheumatology, Department of Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada
| | - M. Liam Martin
- Division of Rheumatology, Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada
| | - David B. Hogan
- Geriatrics, Internal Medicine, Division of Geriatric Medicine, University of Ottawa, Ottawa, ON, Canada
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Efficacy and Safety of Etanercept in Elderly Patients with Rheumatoid Arthritis: A Post-Hoc Analysis of Randomized Controlled Trials. Drugs Aging 2019; 36:853-862. [PMID: 31292906 DOI: 10.1007/s40266-019-00691-8] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/06/2023]
Abstract
BACKGROUND Elderly individuals are disproportionately affected by rheumatoid arthritis (RA), but few studies have addressed the efficacy and safety of treatments in this population. OBJECTIVE Our objective was to assess the efficacy and safety of etanercept in elderly patients (aged ≥ 65 years) with RA. METHODS The efficacy analysis was a post hoc analysis of data from the open-label period of three phase IV clinical trials of etanercept for RA. Least squares (LS) change from baseline (cfb) in 28-joint Disease Activity Score (DAS28), Health Assessment Questionnaire Disability Index (HAQ-DI), and modified Total Sharp Scores (mTSS) were analyzed by age (< 65 vs. ≥ 65 years) for each study. The safety analyses were of data pooled from the double-blind, placebo-controlled periods of 19 phase I-IV randomized studies of etanercept in patients with RA. The percentage occurrence of adverse events (AEs) in placebo- and etanercept-treated patients was analyzed by age (< 65 vs. ≥ 65 years). RESULTS There were no significant differences in LS mean cfb in DAS28 or mTSS between the two age groups. LS mean cfb in HAQ-DI scores was consistently lower in elderly than in non-elderly patients, although significant differences were not observed in all trials. Overall, AE occurrence was higher in elderly than non-elderly patients, regardless of treatment. In etanercept-treated patients, there were small yet statistically significant increases in the occurrence of congestive heart failure, serious infections, and non-melanoma skin cancers in elderly versus non-elderly patients. For most AEs, occurrence did not significantly differ between elderly and non-elderly patients. CONCLUSION Overall, there were no substantial differences in the efficacy or safety of etanercept between elderly and non-elderly patients with RA.
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Oishi S, Wendling D, Sibilia J, Job-Deslandre C, Guillevin L, Benichou J, Flipo RM, Duquenne C, Guillemin F, Saraux A. Treatment of active rheumatoid arthritis: comparison of patients younger vs older than 75 years (CORPUS cohort). Hum Vaccin Immunother 2018; 14:2612-2617. [PMID: 30230962 PMCID: PMC6314403 DOI: 10.1080/21645515.2018.1522470] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/27/2022] Open
Abstract
Objectives: Little information is available on the characteristics of elderly patients starting TNFα antagonist treatment for rheumatoid arthritis (RA). The objective of this work was to compare prescription patterns in RA patients younger vs. older than 75 years. Methods: Biologic-naive patients with active RA (DAS28 > 3.2) despite first-line therapy were included between 2007 and 2009 in the prospective, multicentre, longitudinal, observational, population-based CORPUS-RA cohort. TNFα antagonist users were defined as having received at least one TNFα antagonist during the first study year. The groups < 75 years and ≥ 75 years were compared regarding comorbidities, inflammation (CRP and ESR), disease activity (DAS28), disability (HAQ-DI), number of physician visits, and treatment. To verify the impact of the cut off, we also compared patients aged 70 years or more to patients younger than 70 years. Results: Of 543 RA patients, 382 had complete one-year follow-up data, including 114 TNFα antagonist users, 3 (6%) among the 49 patients aged 75 years or over and 111 (32%) of the 333 patients younger than 75 years (p < 0.01). Disease activity in the two age groups was similar at inclusion and after one year. Comorbidities and a history of auto-immunity were more common in the older group. Compared to their younger counterparts, the older patients received glucocorticoids more often (p = 0.003) and synthetic disease-modifying anti-rheumatic drugs less often (p = 0.01). Conclusion: TNFα antagonists are used less often and glucocorticoids more often in elderly patients with active RA compared to their younger counterparts. The fact that this study was performed in 2007–9 is a limitation in terms of relevance to today’s patients and further studies should be conducted in new cohorts of active RA.
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Affiliation(s)
- Sachiyo Oishi
- a Rheumatology department , Centre National de Référence des Maladies Auto-Immunes Rares (CERAINO), CHU Brest , Brest Cedex , France
| | - Daniel Wendling
- b Rheumatology department , Besançon University Hospital, Boulevard Fleming , Besançon , France.,c EA 4266 , Franche-Comté University , Besançon , France
| | - Jean Sibilia
- d Rheumatology department , Hautepierre University Hospital , Strasbourg , France
| | | | - Loic Guillevin
- f Department of Internal Medicine , Cochin-Paris University Hospital , Paris , France
| | - Jacques Benichou
- g Department of Biostatistics and Clinical Research , Rouen University Hospital , Rouen , France.,h INSERM U1219 , University of Rouen , Rouen , France
| | - René Marc Flipo
- i Rheumatology department , Lille University Hospital , Lille , France
| | - Carole Duquenne
- a Rheumatology department , Centre National de Référence des Maladies Auto-Immunes Rares (CERAINO), CHU Brest , Brest Cedex , France
| | - Francis Guillemin
- j INSERM, CIC-EC 1433 , Université de Lorraine, Brabois University Hospital , Vandoeuvre-lès-Nancy , France
| | - Alain Saraux
- k Rheumatology department, Centre National de Référence des Maladies Auto-Immunes Rares (CERAINO), CHU Brest, and INSERM UMR 1227, Laboratoire d'Immunothérapie et Pathologies lymphocytaires B, Labex 'Immunotherapy, Graft, Oncology' , Université de Brest , Brest , Cedex , France
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Khan MS, Roberts MS. Challenges and innovations of drug delivery in older age. Adv Drug Deliv Rev 2018; 135:3-38. [PMID: 30217519 DOI: 10.1016/j.addr.2018.09.003] [Citation(s) in RCA: 43] [Impact Index Per Article: 6.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/19/2018] [Revised: 08/31/2018] [Accepted: 09/07/2018] [Indexed: 12/12/2022]
Abstract
Both drug delivery performance and various age-related physical, mental and physiological changes can affect drug effectiveness and safety in elderly patients. The many drug delivery systems developed over the years include recent novel transdermal, nasal, pulmonary and orally disintegrating tablets that provide consistent, precise, timely and more targeted drug delivery. Certain drug delivery systems may be associated with suboptimal outcomes in the elderly because of the nature of drug present, a lack of appreciation of the impact of age-related changes in drug absorption, distribution and clearance, the limited availability of pharmacokinetic, safety and clinical data. Polypharmacy, patient morbidity and poor adherence can also contribute to sub-optimal drug delivery systems outcomes in the elderly. The development of drug delivery systems for the elderly is a poorly realised opportunity, with each system having specific advantages and limitations. A key challenge is to provide the innovation that best meets the specific physiological, psychological and multiple drug requirements of individual elderly patients.
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Dalal DS, Duran J, Brar T, Alqadi R, Halladay C, Lakhani A, Rudolph JL. Efficacy and safety of biological agents in the older rheumatoid arthritis patients compared to Young: A systematic review and meta-analysis. Semin Arthritis Rheum 2018; 48:799-807. [PMID: 30185379 DOI: 10.1016/j.semarthrit.2018.07.009] [Citation(s) in RCA: 23] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/12/2018] [Revised: 06/06/2018] [Accepted: 07/23/2018] [Indexed: 12/30/2022]
Abstract
OBJECTIVE Biologic anti-rheumatic drugs are used with less frequency among older patients compared to young patients. This population is less represented in studies performed to evaluate the efficacy and safety of this drugs. We aimed to assess the efficacy and safety of biological agents between the older RA patients compared to young. METHODS A comprehensive, systematic search was conducted in major indexing databases using key terms for RA and each biological agent. The review process was completed by 2 investigators. Both randomized controlled trials and observational studies of at least 6-month duration conducted in adult RA patients were included. Outcomes of interest were clinical efficacy and safety. Effect-estimates were pooled using random-effects modeling if 4 or more studies used the same scale and time-frame for measuring outcomes. RESULTS 24 studies (16 focusing on anti-TNF agents) representing 63,705 patients (24% were older) were included. Older RA patients had worse baseline RA disease activity, longer disease duration at the time of enrollment in the trial (14.4 ± 3.6 vs. 10.9 ± 3.6 years; p < 0.001) and higher steroid use (73.2 vs. 64.7%, p < 0.001) than younger. 5 out of 6 studies assessing anti-TNF agents showed worse efficacy outcomes in older patients. The pooled OR of infection and ADRs with anti-TNF agents in older compared to young RA patients was OR 1.59 (95% CI: 1.45-1.76) and 1.40 (95% CI: 1.23-1.61) respectively. CONCLUSIONS Older patients had worse safety and efficacy with biological agents but also had worse baseline disease activity. There was significant heterogeneity in reporting outcomes and very limited studies in biological agents other than anti-TNF drugs.
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Affiliation(s)
- Deepan S Dalal
- Warren Alpert School of Brown University, Providence, RI, USA.
| | | | - Tina Brar
- Warren Alpert School of Brown University, Providence, RI, USA
| | - Rasha Alqadi
- Warren Alpert School of Brown University, Providence, RI, USA; Roger Williams Medical Center, Providence, RI, USA
| | - Christopher Halladay
- Center of Innovation in Long Term Services and Supports, Providence VA Medical Center, Providence, RI, USA
| | - Alisha Lakhani
- Warren Alpert School of Brown University, Providence, RI, USA
| | - James L Rudolph
- Warren Alpert School of Brown University, Providence, RI, USA; Center of Innovation in Long Term Services and Supports, Providence VA Medical Center, Providence, RI, USA
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Investigation into the Impact of Aging on Serious Adverse Events Associated with Antirheumatic Agents Using the Japanese Adverse Drug Event Report Database. Pharmaceut Med 2018. [DOI: 10.1007/s40290-018-0237-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
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Okazaki M, Kobayashi H, Shimizu H, Ishii Y, Yajima T, Kanbori M. Safety, Effectiveness, and Treatment Persistence of Golimumab in Elderly Patients with Rheumatoid Arthritis in Real-World Clinical Practice in Japan. Rheumatol Ther 2018; 5:135-148. [PMID: 29500791 DOI: 10.1007/s40744-018-0101-y] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/16/2018] [Indexed: 12/19/2022] Open
Abstract
INTRODUCTION Golimumab has been proven as an effective treatment for rheumatoid arthritis in clinical trials. However, there is a scarcity of data regarding its use in elderly patients in a real-world setting. This study aims to evaluate the safety, effectiveness, and treatment persistence of golimumab in elderly Japanese patients (≥ 75 years) with rheumatoid arthritis. METHODS This study was a post hoc analysis of post-marketing surveillance data on 5137 Japanese patients with active rheumatoid arthritis who received golimumab for 24 weeks. The study population was divided into two age groups (younger: < 75 years and elderly: ≥ 75 years), and the safety, effectiveness, and treatment persistence of golimumab were assessed. Also, the reasons for discontinuing golimumab treatment were analyzed by multi-logistic regression. RESULTS During golimumab treatment over 24 weeks, younger and elderly groups exhibited comparable improvement of disease activity as measured by EULAR response criteria with similar overall rates of adverse events. However, the survival curve of golimumab for elderly patients was significantly different from that for younger patients due largely to the discontinuation at 4 weeks. The most common reason for discontinuation in elderly patients was patient choice, while it was disease progression in younger patients. Analysis of elderly patients who discontinued treatment by their own decision identified EULAR good response as a factor associated with continuation of golimumab treatment whereas no predictive factor associated with discontinuation was identified. CONCLUSIONS The safety and effectiveness of golimumab treatment in elderly Japanese patients aged 75 years or older were comparable to those in younger patients in real-world clinical practice. Analysis of the survival curves suggested that continuous use of golimumab might further improve clinical benefit of golimumab in elderly patients, underpinning the importance of effective communication between physicians and elderly patients based on the treat-to-target strategy. FUNDING Janssen Pharmaceutical K.K. and Mitsubishi Tanabe Pharma Corporation.
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Affiliation(s)
- Masateru Okazaki
- Immunology Department, Medical Affairs Division, Janssen Pharmaceutical K.K., Tokyo, Japan.
| | - Hisanori Kobayashi
- Immunology Department, Medical Affairs Division, Janssen Pharmaceutical K.K., Tokyo, Japan
| | - Hirohito Shimizu
- Immunology Department, Medical Affairs Division, Janssen Pharmaceutical K.K., Tokyo, Japan
| | - Yutaka Ishii
- Immunology Department, Medical Affairs Division, Janssen Pharmaceutical K.K., Tokyo, Japan
| | - Tsutomu Yajima
- Biostatistics Department, Research and Development Division, Janssen Pharmaceutical K.K., Tokyo, Japan
| | - Masayoshi Kanbori
- Japan Safety and Surveillance Division, Research and Development Division, Janssen Pharmaceutical K.K., Tokyo, Japan
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Kostović K, Žužul K, Čeović R, Bukvić Mokos Z. Psoriasis in the mature patient: Therapeutic approach in the era of biologics. Clin Dermatol 2018; 36:222-230. [DOI: 10.1016/j.clindermatol.2017.10.013] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
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Rheumatoid arthritis treated with tocilizumab in two patients with complicated chronic liver disease with portal hypertension. Joint Bone Spine 2018; 85:115-117. [DOI: 10.1016/j.jbspin.2017.07.004] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/22/2017] [Accepted: 07/18/2017] [Indexed: 11/21/2022]
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Herpes zoster: Risk and prevention during immunomodulating therapy. Joint Bone Spine 2017; 84:21-27. [DOI: 10.1016/j.jbspin.2016.04.001] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/17/2016] [Indexed: 12/30/2022]
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Karube H, Kamoi K, Ohno-Matsui K. Anti-TNF therapy in the management of ocular attacks in an elderly patient with long-standing Behçet's disease. Int Med Case Rep J 2016; 9:301-304. [PMID: 27729816 PMCID: PMC5045905 DOI: 10.2147/imcrj.s117731] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND Ocular symptoms in Behçet's disease (BD) begin mostly before 30 years of age according to international surveys, and BD activity may decrease with age. Information regarding the treatment of ocular symptoms in elderly BD patients is thus scant. Anti-TNFα antibody has recently demonstrated strong effects against recurrent uveitis in BD, but the efficacy and safety of anti-TNFα therapy in elderly patients remain unclear. We report herein the case of an elderly patient with long-standing uveitis due to BD who was successfully treated with two types of anti-TNF therapy. CASE An 81-year-old Japanese man presented with a 33-year history of ocular inflammation due to BD. As immunosuppressive agents, such as cyclosporine A, were difficult to use because he had undergone removal of the left kidney due to cancer, he was treated with colchicine. However, attacks of ocular inflammation persisted around nine times a year. After colchicine had been changed to infliximab, ocular inflammation was fairly well controlled, but ocular attacks still occurred once or twice a year. As soon as intestinal hemorrhage related to BD occurred, infliximab was switched to adalimumab. After this switch, ocular attacks resolved and visual acuity was maintained at 1.0. Intestinal lesions were also well controlled, and no side effects were seen. CONCLUSION This represents the first report of the application of two types of anti-TNFα therapy for ocular attacks in an elderly BD patient. In addition to infliximab, adalimumab appears to offer an alternative therapy for refractory, long-standing BD-related uveitis in elderly patients.
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Affiliation(s)
- Hisako Karube
- Department of Ophthalmology and Visual Science, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan
| | - Koju Kamoi
- Department of Ophthalmology and Visual Science, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan
| | - Kyoko Ohno-Matsui
- Department of Ophthalmology and Visual Science, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan
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Cho SK, Sung YK, Kim D, Won S, Choi CB, Kim TH, Jun JB, Yoo DH, Bae SC. Drug retention and safety of TNF inhibitors in elderly patients with rheumatoid arthritis. BMC Musculoskelet Disord 2016; 17:333. [PMID: 27507033 PMCID: PMC4977640 DOI: 10.1186/s12891-016-1185-6] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/01/2016] [Accepted: 07/28/2016] [Indexed: 01/16/2023] Open
Abstract
BACKGROUND The concerns about the development of adverse events (AEs) in elderly RA patients as a result of age-related changes in drug metabolism and the presence of comorbid illnesses are emphasizing due to increasing prevalence of rheumatoid arthritis (RA) in old age. However, they tend to be inadequately represented in RA clinical trials because of the exclusion criteria that are commonly applied. The tolerability and safety of TNF inhibitors in elderly patients have not been also evaluated in clinical practice. This study aimed to evaluate the retention rate and safety of TNF inhibitors (TNFI) in elderly RA patients. METHODS Total 429 RA patients (838 person-years [PYs]) treated with TNFI from a retrospective biologic DMARDs registry. Patients were divided into an elderly (age ≥60 years) and a younger group (<60 years). The drug retention rates of both groups were compared using Kaplan-Meier curves. Potential predictors of TNFI discontinuation in the elderly were examined using Cox regression analysis. The incidence rate (IR) of serious adverse events (SAEs) in the elderly group was compared to that of the young group. RESULTS Of the patients, 24.9 % (n = 107, 212 PYs) were in the elderly group. Regarding the retention rates of TNFI in 3 years, there was no significant difference between the elderly and younger group (p = 0.33). The major cause of discontinuation in elderly patients was AE (34.3 %), whereas that was drug ineffectiveness (41.7 %) in younger patients. Age (HR 1.09, CI 1.02-1.16) was a predictor of discontinuation, while the presence of comorbidity (HR 0.37, CI 0.15-0.91) had a protective effect against drug discontinuation in the elderly. The IR of SAEs in the elderly (6.13/100 PYs) was higher than in the younger group (5.11/100 PYs). CONCLUSIONS The retention rate of TNFI in the elderly was comparable with that in younger patients. The major cause of discontinuation in the elderly patients was AEs, while it was drug ineffectiveness in younger patients. The IR of SAEs in the elderly was higher than in the younger patients.
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Affiliation(s)
- Soo-Kyung Cho
- Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, 133-792 South Korea
- Clinical Research Center for Rheumatoid Arthritis, Seoul, South Korea
| | - Yoon-Kyoung Sung
- Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, 133-792 South Korea
- Clinical Research Center for Rheumatoid Arthritis, Seoul, South Korea
| | - Dam Kim
- Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, 133-792 South Korea
- Clinical Research Center for Rheumatoid Arthritis, Seoul, South Korea
| | - Soyoung Won
- Clinical Research Center for Rheumatoid Arthritis, Seoul, South Korea
| | - Chan-Bum Choi
- Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, 133-792 South Korea
- Clinical Research Center for Rheumatoid Arthritis, Seoul, South Korea
| | - Tae-Hwan Kim
- Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, 133-792 South Korea
| | - Jae-Bum Jun
- Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, 133-792 South Korea
| | - Dae-Hyun Yoo
- Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, 133-792 South Korea
| | - Sang-Cheol Bae
- Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, 133-792 South Korea
- Clinical Research Center for Rheumatoid Arthritis, Seoul, South Korea
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Effect of age at rheumatoid arthritis onset on clinical, radiographic, and functional outcomes: The ESPOIR cohort. Joint Bone Spine 2016; 83:511-5. [PMID: 26992954 DOI: 10.1016/j.jbspin.2015.09.010] [Citation(s) in RCA: 37] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/29/2015] [Accepted: 09/09/2015] [Indexed: 12/24/2022]
Abstract
OBJECTIVES To investigate whether age at disease onset determines clinical, radiographic or functional outcomes in a cohort of early RA. METHODS The ESPOIR cohort is a multicenter cohort of patients with early arthritis. We selected patients fulfilling the 2010 ACR/EULAR criteria for RA during the first 3years of follow-up. Patients were pooled into 3 groups by age at RA onset: <45years (young-onset RA [YORA]), 45 to 60years (intermediate-onset RA [IORA]) and>60years (late-onset RA [LORA]). The following outcomes were compared at baseline and during the first 3years of follow-up: Simple Disease Activity Index (SDAI) remission rate, one additional erosion, Health Assessment Questionnaire Disability Index (HAQ-DI)<0.5 and first disease-modifying anti-rheumatic drug (DMARD) continuation rate. RESULTS We included 698 patients (median [interquartile range] age 50.3 [39.8-57.2]years), 266 YORA, 314 IORA, and 118 LORA. At 1year, SDAI remission was greater for YORA than IORA and LORA (P<0.0001). Having at least one additional erosion was greater for LORA and IORA than YORA after 1year (P=0.009) and 3years (P=0.017). The proportion of patients with HAQ score<0.5 was greater for YORA than IORA and LORA at 1 (P=0.007), 2 and 3years. First DMARD continuation rate was lower for YORA than other groups during the 3years (P=0.005). CONCLUSIONS In a cohort of early RA, young age at disease onset is associated with high rate of remission at 1year, no radiographic progression at 3years and low functional score during 3-year follow-up.
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Affiliation(s)
- Tsuyoshi TAKEDA
- Department of Internal Medicine, Japan Organization of Occupational Health and Safety, Hokkaido Spinal Cord Injury Center
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Diagnosis and Management of Late-Onset Spondyloarthritis: Implications of Treat-to-Target Recommendations. Drugs Aging 2015; 32:515-24. [DOI: 10.1007/s40266-015-0280-y] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
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