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Sebastian SA, Kaiwan O, Co EL, Mehendale M, Mohan BP. Current Pharmacologic Options and Emerging Therapeutic Approaches for the Management of Ulcerative Colitis: A Narrative Review. Spartan Med Res J 2024; 9:123397. [PMID: 39280117 PMCID: PMC11402463 DOI: 10.51894/001c.123397] [Citation(s) in RCA: 3] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 09/18/2024] Open
Abstract
Introduction Ulcerative colitis (UC) is a chronic inflammatory bowel disorder (IBD) with periods of relapse and remission. Current advancements in clinical research have led to the development of more refined and effective medical therapy for UC. Summary of the Evidence Traditional therapeutic agents such as 5-aminosalicylates (5-ASAs), sulfasalazine (SASP), corticosteroids, and immunomodulatory drugs have remained the gold standard for decades. However, their novel formulations and dosage regimens have changed their sequences in the medical management of UC. Several other novel drugs are in the final phases of clinical development or have recently received regulatory approval designed to target specific mechanisms involved in the inflammatory cascade for UC. Conclusions This narrative review sought to provide a comprehensive knowledge of the potential benefits of standard and emerging therapies, including novel formulations, new chemical entities, and novel therapeutic approaches in managing UC. Keywords: Ulcerative colitis, 5- Aminosalicylic acid, sulfasalazine, corticosteroids, biologics, immunomodulators, novel formulations.
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Affiliation(s)
| | - Oroshay Kaiwan
- Department of Medicine Northeast Ohio Medical University, USA
| | - Edzel L Co
- Department of Internal Medicine University of Santo Tomas, Manila
| | - Meghana Mehendale
- Smolensk State Medical University, Russia Department of Internal Medicine
| | - Babu P Mohan
- Department of Gastroenterology University of Utah School of Medicine, Utah, USA
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Magro F, Pai RK, Kobayashi T, Jairath V, Rieder F, Redondo I, Lissoos T, Morris N, Shan M, Park M, Peyrin-Biroulet L. Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes. J Crohns Colitis 2023; 17:1457-1470. [PMID: 37057827 PMCID: PMC10588772 DOI: 10.1093/ecco-jcc/jjad050] [Citation(s) in RCA: 13] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/30/2022] [Indexed: 04/15/2023]
Abstract
BACKGROUND AND AIMS To evaluate the effect of mirikizumab, a p19-targeted anti-interleukin-23, on histological and/or endoscopic outcomes in moderately-to-severely active ulcerative colitis [UC]. METHODS Endoscopic remission [ER], histological improvement [HI], histological remission [HR], histological-endoscopic mucosal improvement [HEMI], and histological-endoscopic mucosal remission [HEMR] were assessed at Week [W]12 [LUCENT-1: N = 1162, induction] and W40 [LUCENT-2: N = 544, maintenance] for patients randomised to mirikizumab or placebo. Analyses were performed to evaluate predictors of: HEMI at W12 with mirikizumab and HEMR at W40 in patients re-randomised to subcutaneous [SC] mirikizumab; associations between W12 histological/endoscopic endpoints and W40 outcomes in mirikizumab responders re-randomised to mirikizumab SC; and associations between W40 endoscopic normalisation [EN] with/without HR. RESULTS Significantly more patients treated with mirikizumab achieved HI, HR, ER, HEMI, and HEMR vs placebo [p <0.001], irrespective of prior biologic/tofacitinib failure [p <0.05]. Lower clinical baseline disease activity, female sex, no baseline immunomodulator use, and no prior biologic/tofacitinib failure were predictors of HEMI at W12 [p <0.05]. Corticosteroid use and longer disease duration were negative predictors of achieving HEMR at W40 [p <0.05]. W12 HI, HR, or ER was associated with W40 HEMI or HEMR [p <0.05]; ER at W12 was associated with clinical remission [CR] [p <0.05] and corticosteroid-free remission [CSFR] at W40 [p = 0.052]. HR and HEMR at W12 were associated with CSFR, CR, and symptomatic remission at W40. Alternate HEMR [EN + HR] at W40 was associated with bowel urgency remission at W40 [p <0.05]. CONCLUSIONS Early resolution of endoscopic and histological inflammation with mirikizumab is associated with better UC outcomes. Clinicaltrials.gov: LUCENT-1, NCT03518086; LUCENT-2, NCT03524092.
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Affiliation(s)
- Fernando Magro
- Department of Gastroenterology, University Hospital São João, Porto, Portugal
- CINTESIS@RISE - Health Research Network, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Rish K Pai
- Department of Laboratory Medicine and Pathology, Mayo Clinic, Scottsdale, AZ, USA
| | - Taku Kobayashi
- Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Minato-ku, Tokyo, Japan
| | - Vipul Jairath
- Division of Gastroenterology, Department of Medicine, Western University, London, ON, Canada
- Alimentiv Inc., London, ON, Canada
- Department of Epidemiology and Biostatistics, Western University, London, ON, Canada
| | - Florian Rieder
- Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases and Surgery Institute, Cleveland Clinic Foundation, Cleveland, OH, USA
- Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, OH, USA
| | - Isabel Redondo
- Eli Lilly Portugal, Produtos Farmacêuticos Lda., Lisbon, Portugal
| | | | | | | | | | - Laurent Peyrin-Biroulet
- University of Lorraine, Inserm, NGERE, Nancy, and Groupe Hospitalier Privé Ambroise Paré - Hartmann, Paris IBD Center, Neuilly sur Seine, France
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Haugbo HO, Klepp P, Verket A. Ulcerative colitis and periodontitis - a cross-sectional pilot study from a Norwegian cohort. Acta Odontol Scand 2023; 81:541-548. [PMID: 37171849 DOI: 10.1080/00016357.2023.2210660] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/21/2022] [Accepted: 04/30/2023] [Indexed: 05/13/2023]
Abstract
BACKGROUND Inflammatory bowel disease, which includes ulcerative colitis (UC), is an inflammatory disorder with potential impact on periodontal disease, but evidence to date for this association is limited. The primary aim of this study was to investigate the prevalence of periodontitis according to the 2017-classification in a cohort of subjects with UC. The secondary aim was to assess a potential correlation of periodontal status with previous UC disease parameters and to assess oral health-related quality-of-life. METHOD A cohort from a community hospital in Norway with confirmed extensive UC was comprehensively examined. Periodontal parameters, OHIP-14 and demographic variables were collected. Previous UC data including colon activity index (CAI), Mayo score and years of UC diagnosis was used to explore a potential correlation with periodontal status. RESULTS A total of 50 out of 63 invited patients participated. According to the 2017-classification, 74% of the patients presented periodontitis. No correlation was found between periodontitis (stage, grade, bleeding on probing or probing pocket depth ≥6mm) and CAI, Mayo score, or years with UC diagnosis. CONCLUSIONS Within the limitations of this study, the prevalence of periodontitis among patients with mild UC for more than 12 years was in line with that reported from a Norwegian general population. No correlation between periodontitis and UC disease indices or years with UC diagnosis was observed. The study suggests that the susceptibility to periodontitis may be limited in patients with well treated or mild UD who regularly attend the dental office, despite a considerable UC disease duration.
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Affiliation(s)
- Helena O Haugbo
- Department of Hospital Dentistry, Lovisenberg Diaconal Hospital, Oslo, Norway
- Institute of Clinical Dentistry, Department of Periodontology, University of Oslo, Oslo, Norway
| | - Pasquale Klepp
- Department of Gastroenterology, Lovisenberg Diaconal Hospital, Oslo, Norway
| | - Anders Verket
- Institute of Clinical Dentistry, Department of Periodontology, University of Oslo, Oslo, Norway
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Adriana Estrella GR, María Eva GT, Alberto HL, María Guadalupe VD, Azucena CV, Sandra OS, Noé AV, Francisco Javier LM. Limonene from Agastache mexicana essential oil produces antinociceptive effects, gastrointestinal protection and improves experimental ulcerative colitis. JOURNAL OF ETHNOPHARMACOLOGY 2021; 280:114462. [PMID: 34324951 DOI: 10.1016/j.jep.2021.114462] [Citation(s) in RCA: 12] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/28/2021] [Revised: 07/09/2021] [Accepted: 07/24/2021] [Indexed: 05/27/2023]
Abstract
ETHNOPHARMACOLOGY RELEVANCE Agastache mexicana is a popular plant of great demand in folk medicine, essentially due to its calming properties and for alleviating arthritic, muscular and abdominal pain. Despite its spectrum for pain relief, pharmacological studies of its bioactive constituents have been barely investigated. AIM OF THE STUDY To evaluate protective properties of the A. mexicana and bioactive compounds improving pathological gastrointestinal conditions in rodents. MATERIAL AND METHODS Different doses of the essential oil of A. mexicana ssp. mexicana and ssp. xolocotziana (30-562.2 mg/kg, i.p.) and individual monoterpenes (3-300 mg/kg, i.p.) were evaluated in an abdominal pain model. The most active monoterpene limonene and sulfasalazine (reference drug, 100 mg/kg, p.o.) were also evaluated in the oxazolone-induced colitis model using an oral gavage, where some inflammatory cytokines were analyzed by enzyme-linked immunosorbent assays. Finally, colonic histological assessment and gastroprotection in the absolute ethanol-induced ulcer model were explored. RESULTS Our results demonstrated that the essential oil of both subspecies produced a significant reduction in the abdominal writhes, where monoterpenes limonene and pulegone were partially responsible bioactive metabolites. Limonene showed the major antinociceptive efficacy in the writhing test. It also significantly decreased hyperalgesia, pathological biomarkers, and colonic inflammatory cytokines in the oxazolone-induced colitis model, as well as prevention in gastric damage. CONCLUSIONS Present results provide scientific evidence to reinforce the use of A. mexicana in the traditional medicine for gastrointestinal conditions, mainly related to pain and inflammation, demonstrating the potential of monoterpenes as natural products in the therapeutics of gastrointestinal affections such as ulcer, colitis, and abdominal pain.
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Affiliation(s)
- González-Ramírez Adriana Estrella
- Laboratorio de Neurofarmacología de Productos Naturales de la Dirección de Investigaciones en Neurociencias, Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz, Calzada México-Xochimilco 101, Col. San Lorenzo Huipulco, C.P. 14370, CDMX, Mexico; Departamento de Farmacobiología, CINVESTAV-IPN, Calzada de los Tenorios 235, Col. Granjas Coapa, C.P. 14330, CDMX, Mexico.
| | - González-Trujano María Eva
- Laboratorio de Neurofarmacología de Productos Naturales de la Dirección de Investigaciones en Neurociencias, Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz, Calzada México-Xochimilco 101, Col. San Lorenzo Huipulco, C.P. 14370, CDMX, Mexico.
| | - Hernandez-Leon Alberto
- Laboratorio de Neurofarmacología de Productos Naturales de la Dirección de Investigaciones en Neurociencias, Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz, Calzada México-Xochimilco 101, Col. San Lorenzo Huipulco, C.P. 14370, CDMX, Mexico.
| | - Valle-Dorado María Guadalupe
- Laboratorio de Neurofarmacología de Productos Naturales de la Dirección de Investigaciones en Neurociencias, Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz, Calzada México-Xochimilco 101, Col. San Lorenzo Huipulco, C.P. 14370, CDMX, Mexico.
| | - Carballo-Villalobos Azucena
- Departamento de Química Inorgánica y Nuclear, Facultad de Química, Universidad Nacional Autónoma de México, Investigación Científica 70, C.U., Coyoacán, 04510, CDMX, Mexico.
| | - Orozco-Suárez Sandra
- Unidad de Investigación Médica en Enfermedades Neurológicas, Hospital de Especialidades, Centro Médico Nacional Siglo XXI, IMSS, Av. Cuauhtémoc 330, Col. Doctores, 06720, CDMX, Mexico.
| | - Alvarado-Vásquez Noé
- Departamento de Bioquímica, Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Calz. de Tlalpan 04502, Col. Sección XVI, 14080, CDMX, Mexico.
| | - López-Muñoz Francisco Javier
- Departamento de Farmacobiología, CINVESTAV-IPN, Calzada de los Tenorios 235, Col. Granjas Coapa, C.P. 14330, CDMX, Mexico.
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Jo IH, Lee KM, Kim DB, Kim JW, Lee J, Jeen YT, Kim TO, Kim JS, Park JJ, Hong SN, Park DI, Kim HS, Lee YJ, Kim Y. Quality of Life in Newly Diagnosed Moderate-to-Severe Ulcerative Colitis: Changes in the MOSAIK Cohort Over 1 Year. Gut Liver 2021; 16:384-395. [PMID: 34373363 PMCID: PMC9099394 DOI: 10.5009/gnl210141] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/30/2021] [Revised: 05/10/2021] [Accepted: 06/14/2021] [Indexed: 12/07/2022] Open
Abstract
Background/Aims Improving quality of life has been gaining importance in ulcerative colitis (UC) management. The aim of this study was to investigate changes in health-related quality of life (HRQL) and related factors in patients with moderate-to-severe UC. Methods A multicenter, hospital-based, prospective study was performed using a Moderate-to-Severe Ulcerative Colitis Cohort in Korea (the MOSAIK). Changes in HRQL, evaluated using the 12-Item Short Form Health Survey (SF-12) and Inflammatory Bowel Disease Questionnaire (IBDQ), were analyzed at the time of diagnosis and 1 year later. Results In a sample of 276 patients, the mean age was 38.4 years, and the majority of patients were male (59.8%). HRQL tended to increase in both the IBDQ and SF-12 1 year after diagnosis. A higher partial Mayo score was significantly related to poorer HRQL on the IBDQ and SF-12 in a linear mixed model (p<0.01). Inflammatory markers such as C-reactive protein (CRP) or erythrocyte sedimentation rate also showed a negative correlation on HRQL (p<0.05). Patients whose IBDQ score improved by 16 or more (71.2%) in 1 year were younger, tended to be nonsmokers, and had a lower partial Mayo score and CRP than those whose IBDQ score did not. There was no significant association between HRQL and disease extent, treatments at diagnosis, or the highest treatment step during the 1-year period. Conclusions Optimally controlled disease status improves HRQL in patients with moderate-to-severe UC. The partial Mayo score and inflammatory markers may be potential indicators reflecting the influence of UC on patient`s daily lives.
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Affiliation(s)
- Ik Hyun Jo
- Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea
| | - Kang-Moon Lee
- Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea
| | - Dae Bum Kim
- Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea
| | - Ji Won Kim
- Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea
| | - Jun Lee
- Department of Internal Medicine, Chosun University Hospital, Gwangju, Korea
| | - Yoon Tae Jeen
- Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea
| | - Tae-Oh Kim
- Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Korea
| | - Joo Sung Kim
- Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea
| | - Jae Jun Park
- Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Sung Noh Hong
- Department of Internal Medicine, Samsung Medical Center, Seoul, Korea
| | - Dong Il Park
- Department of Internal Medicine, Kangbuk Samsung Hospital, Seoul, Korea
| | - Hyun-Soo Kim
- Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, Korea
| | - Yoo Jin Lee
- Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Korea
| | - Youngdoe Kim
- Clinical Research Science Team, Medical Affairs, Janssen Korea Ltd., Seoul, Korea
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Teich N, Grümmer H, Jörgensen E, Liceni T, Holtkamp-Endemann F, Fischer T, Hohenberger S. Golimumab improves work productivity in patients suffering from moderate to severe ulcerative colitis: results of a prospective study over 24 months. BMC Gastroenterol 2021; 21:161. [PMID: 33845784 PMCID: PMC8042988 DOI: 10.1186/s12876-021-01747-z] [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] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/12/2021] [Accepted: 03/30/2021] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND Ulcerative colitis (UC) is a chronic inflammatory bowel disease with recurrent episodes of debilitating symptoms negatively affecting work productivity and health-related quality of life (HRQoL). The use of biologics in UC treatment improves work and HRQoL but prospective long-term data concerning the treatment with TNFα inhibitor golimumab in UC patients are still rare. Therefore, our study aimed to evaluate the change in work productivity, capacity for daily activities and HRQoL in UC patients treated with golimumab in Germany. METHODS Using the Work Productivity and Activity Impairment questionnaire, the change in work productivity and in capacity for daily activities after 3 months and over the whole observational period of 24 months were assessed (both primary endpoints). Disease-specific and health-related quality of life (QoL) were analyzed with the Inflammatory Bowel Disease Questionnaire (IBDQ), the Short-Form 12 Health Survey Questionnaire (SF-12), and the Partial Mayo Score (secondary endpoints). Further, disease-related hospitalization rates were assessed. RESULTS This prospective non-interventional study included 286 patients. Thereof, 212 patients were employed at baseline (modified intention to treat analysis set employed at baseline, mITTe). 61.3% of the mITTe patients had moderate and 17.0% had severe UC. Three months after initiation of golimumab therapy, total work productivity impairment (TWPI) score and activity impairment score improved significantly from baseline with a mean change of - 17.3% (p < 0.0001) and - 14.4% (p < 0.0001), respectively. Results persisted over 24 months (mean change TWPI score: - 24.5%, mean change activity impairment score: - 30.0%). Disease- and health-related QoL also improved significantly under golimumab treatment as indicated by increased IBDQ [mean change: 28.0 (SD: ± 36.1, month 3), 42.1 (SD: ± 39.5, month 24)] and SF-12 scores [PCS-12: 45.9 (SD: ± 8.5), MCS-12: 4.9 (SD: ± 10.6, month 3), PCS-12: 5.9 (SD: ± 9.0), MCS-12: 6.4 (SD: ± 11.1, month 24)]. Disease-related hospitalization rate decreased from 16.0% (BL) to 4.3% at month 24 and the mean number of missed working days due to UC decreased from 8.2 (SD: 17.6, BL) to 0.7 (SD: 2.1) after golimumab induction. CONCLUSIONS Golimumab leads to notable long-term improvements in work productivity, daily activity, HRQoL, and disease-related hospitalization rates in patients with moderate to severe UC. TRIAL REGISTRATION PEI (Paul-Ehrlich-Institute, Langen, Germany) Registration Nr: NIS#255 ( https://www.pei.de/SharedDocs/awb/nis-0201-0300/0255.html ).
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Affiliation(s)
- Niels Teich
- Internistische Gemeinschaftspraxis Für Verdauungs- Und Stoffwechselkrankheiten Leipzig Und Schkeuditz, Nordstraße 21, 04105, Leipzig, Sachsen, Germany.
| | - Harald Grümmer
- Praxis Für Innere Medizin/Gastroenterologie, Allee Nach Sanssouci 7, 14471, Potsdam, Germany
| | - Eric Jörgensen
- Magen-Darm-Zentrum Remscheid, Rosenhügelerstraße 2, 42859, Remscheid, Germany
| | - Thomas Liceni
- MVZ Für Gastroenterologie Am Bayerischen Platz, Innsbrucker Straße 58, 10825, Berlin, Germany
| | - Frank Holtkamp-Endemann
- Gastroenterologische Gemeinschaftspraxis Am Germania-Campus, An der Germania Brauerei 6, 48159, Münster, Germany
| | - Tim Fischer
- Medical Affairs, MSD Sharp & Dohme GmbH, Lindenplatz 1, 85540, Haar, Germany
| | - Susanne Hohenberger
- Medical Affairs, MSD Sharp & Dohme GmbH, Lindenplatz 1, 85540, Haar, Germany
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Li K, Marano C, Zhang H, Yang F, Sandborn WJ, Sands BE, Feagan BG, Rubin DT, Peyrin-Biroulet L, Friedman JR, De Hertogh G. Relationship Between Combined Histologic and Endoscopic Endpoints and Efficacy of Ustekinumab Treatment in Patients With Ulcerative Colitis. Gastroenterology 2020; 159:2052-2064. [PMID: 32853634 DOI: 10.1053/j.gastro.2020.08.037] [Citation(s) in RCA: 62] [Impact Index Per Article: 12.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/30/2020] [Revised: 08/18/2020] [Accepted: 08/19/2020] [Indexed: 12/22/2022]
Abstract
BACKGROUND & AIMS Ustekinumab induces and maintains histologic improvement in patients with ulcerative colitis (UC). The clinical relevance of this endpoint alone, and in combination with endoscopic improvement, is unknown. METHODS Histologic disease activity was evaluated in 2630 colonic biopsy samples from patients with UC treated in the UNIFI phase 3 UC clinical studies of ustekinumab. We evaluated associations between histologic improvement (defined as the composite of neutrophil infiltration in less than 5% of crypts and no crypt destruction, erosions, ulcerations, or granulation tissue) and clinical endpoints at the end of induction (week 8 and 16) and maintenance (week 44) periods. We assessed the validity of a combined histologic and endoscopic (Mayo endoscopy subscore, 0 or 1) improvement endpoint, which we called histo-endoscopic mucosal healing (or histo-endoscopic mucosal improvement). RESULTS Histologic improvement was significantly (P < .0001) associated with clinical remission, lower mean disease activity scores, and greater improvement in disease activity at the end of induction and maintenance studies. Ustekinumab induced and maintained significantly higher rates of histologic improvement at induction week 8 and maintenance week 44 than placebo when more stringent definitions of histologic improvement were used. Histologic improvement and endoscopic improvement following induction were associated with 10% to 20% higher rates of histo-endoscopic mucosal healing, clinical remission, and corticosteroid-free remission at week 44 (all P < .05) in patients who received ustekinumab maintenance therapy. At week 44, 61% of patients (56/92) with histo-endoscopic mucosal healing after induction therapy achieved clinical remission, versus 39% of patients (9/23, P = .0983) and 34% of patients (24/71, P = .0009) with endoscopic or histologic improvement alone after induction, respectively. CONCLUSION Data from the UNIFI program of ustekinumab in patients with UC treated with ustekinumab indicated the achievement of histo-endoscopic mucosal healing after induction therapy is associated with lower disease activity at the end of maintenance therapy than either histologic or endoscopic improvement alone. ClinicalTrials.gov number: NCT02407236.
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Affiliation(s)
- Katherine Li
- Immunology Translational Science, Janssen Research & Development, LLC, Spring House, Pennsylvania
| | - Colleen Marano
- Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania
| | - Hongyan Zhang
- Immunology, Janssen Research & Development, LLC, Spring House, Pennsylvania
| | - Feifei Yang
- Immunology Translational Science, Janssen Research & Development, LLC, Spring House, Pennsylvania
| | - William J Sandborn
- Division of Gastroenterology, University of California San Diego, La Jolla, California
| | - Bruce E Sands
- Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York
| | - Brian G Feagan
- Robarts Clinical Trials, Robarts Research Institute, Western University, London, Ontario, Canada
| | - David T Rubin
- Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, Illinois
| | - Laurent Peyrin-Biroulet
- Gastroenterology Department and Inserm U1256 Nutrition, Genetics, and Environmental Risk Exposure, Nancy University Hospital, Université de Lorraine, Nancy, France
| | - Joshua R Friedman
- Immunology Translational Science, Janssen Research & Development, LLC, Spring House, Pennsylvania.
| | - Gert De Hertogh
- Deparment of Pathology, University Hospitals KU Leuven, Belgium.
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8
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Shi G, Wang D, Xue Z, Zhou X, Fang Y, Feng S, Zhao L. The amelioration of ulcerative colitis induced by Dinitrobenzenesulfonic acid with Radix Hedysari. J Food Biochem 2020; 44:e13421. [PMID: 32776340 DOI: 10.1111/jfbc.13421] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/31/2020] [Revised: 07/05/2020] [Accepted: 07/13/2020] [Indexed: 12/14/2022]
Abstract
Ulcerative colitis (UC) is a chronic inflammatory disease with an unknown precise etiology. This study proves that Radix Hedysari (RH) ameliorates UC. Four RH extracts were used to ameliorate UC induced by 2,4-Dinitrobenzenesulfonic acid by 7 days intervention in agreement to preliminary studies. Compared to treatment with RH extracts, the RH ethanol extract (EE) was found to be more effective in ameliorating UC. With EE, the DAI were significantly decreased. Macroscopic and histopathological assessments suggest that the colon mucosa was repaired, the organizational structure of the colon had been rebuilt. The levels of MPO, TNF-α, IL-1β, and MDA were significantly decreased (p < .01), the levels of T-SOD and CAT were significantly increased (p < .01). Moreover, the compounds in EE were analyzed by HPLC. The results show that EE can ameliorate UC, and its anti-inflammatory capability probably plays an important role. RH can act as a functional food and ameliorate UC. PRACTICAL APPLICATIONS: In this work, the ameliorative effect of RH on UC was evaluated from multiple angles. There are two practical applications of this work. On the one hand, a new approach to ameliorating UC is provided by this work. In addition, UC patients have a new option for improving their symptoms. On the other hand, this work also provides information on how best to process RH for therapeutic use. In addition, we can utilize some compounds of RH that were once considered useless and reduce the waste of natural resources.
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Affiliation(s)
- Gengen Shi
- School of Pharmacy, Lanzhou University, Lanzhou, P.R. China
| | - Donghan Wang
- School of Pharmacy, Lanzhou University, Lanzhou, P.R. China
| | - Zhiyuan Xue
- School of Pharmacy, Lanzhou University, Lanzhou, P.R. China
| | - Xianglin Zhou
- School of Pharmacy, Lanzhou University, Lanzhou, P.R. China
| | - Yaoyao Fang
- School of Pharmacy, Lanzhou University, Lanzhou, P.R. China
| | - Shilan Feng
- School of Pharmacy, Lanzhou University, Lanzhou, P.R. China
| | - Lianggong Zhao
- The Second Hospital of Lanzhou University, Lanzhou, P.R. China
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Teich N, Grümmer H, Jörgensen E, Liceni T, Holtkamp-Endemann F, Fischer T, Hohenberger S. Golimumab in real-world practice in patients with ulcerative colitis: Twelve-month results. World J Gastroenterol 2020; 26:2852-2863. [PMID: 32550760 PMCID: PMC7284175 DOI: 10.3748/wjg.v26.i21.2852] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/06/2020] [Revised: 05/08/2020] [Accepted: 05/23/2020] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND The introduction of biologics has revolutionized the management of the chronic inflammatory bowel disease, ulcerative colitis (UC), with many patients experiencing significant improvements not only in their symptoms but in other outcomes relevant to individuals and society as a whole. In Germany, there are no prospective data > 3 mo that assess the work productivity, daily activities and quality of life (QoL) of patients with moderate-to-severe UC treated with golimumab. AIM To assess change in work productivity, capacity for daily activities and QoL in UC patients treated with golimumab in Germany. METHODS The validated Work Productivity Activity Impairment (WPAI) Questionnaire was used to analyze the change in work productivity, the capacity for daily activities after three months (primary endpoint) and disease specific and health related QoL (HRQoL) up to 1 year (secondary endpoints). The changes in work productivity and activity impairment were evaluated every three months until month twelve compared to baseline. Disease-specific and health-related QoL were assessed with the inflammatory bowel disease questionnaire and with the short-form 12 health survey questionnaire (SF-12). RESULTS This prospective non-interventional study included 287 patients. The analysis population was comprised of 282 patients who had completed at least two visits. At baseline, 61% of patients had moderate UC and 18% had severe UC. Furthermore, 75% of patients worked full-time or part-time at baseline. A total of 212 patients who were employed at the start of the study (employed population) were evaluated for the primary endpoint. Golimumab significantly reduced all WPAI sub-scores compared to baseline after three, six, nine and twelve months after the start of treatment (P < 0.0001). In addition, disease-specific QoL and HRQoL, as measured by the SF-12 questionnaire, improved significantly with golimumab at all evaluation times (P < 0.0001 in each case vs baseline). CONCLUSION Treatment of moderate-to-severe UC with golimumab leads to significant improvements in patient´s work productivity, daily activity and QoL over twelve months.
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Affiliation(s)
- Niels Teich
- Internistische Gemeinschaftspraxis für Verdauungs-und Stoffwechselkrankheiten Leipzig und Schkeuditz, Leipzig 04105, Germany
| | - Harald Grümmer
- Praxis für Innere Medizin/Gastroenterologie, Potsdam 14471, Germany
| | | | - Thomas Liceni
- MVZ für Gastroenterologie am Bayerischen Platz, Berlin 10825, Germany
| | | | - Tim Fischer
- Medical Affairs, MSD Sharp and Dohme GmbH, Haar 85540, Germany
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Fradet C, Kern J, Atanasov P, Wirth D, Borsi A. Impact of surgery and its complications in ulcerative colitis patients in clinical practice: A systematic literature review of real-world evidence in Europe. INTERNATIONAL JOURNAL OF SURGERY OPEN 2020. [DOI: 10.1016/j.ijso.2019.11.010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
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Sebastian S, Roberts J, Waller J, Judge D, Brown C, Davies R, Kachroo S. Remote Monitoring of Patient-Reported Outcomes in Ulcerative Colitis: A Prospective Real-World Pilot Study. PHARMACOECONOMICS - OPEN 2019; 3:359-365. [PMID: 30900117 PMCID: PMC6710315 DOI: 10.1007/s41669-019-0121-8] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/07/2023]
Abstract
INTRODUCTION The 6-point version of the Mayo score relies on two patient-reported outcomes (PRO2): stool frequency and rectal bleeding. We assessed the feasibility and acceptability of remote online PRO2 reporting for golimumab-treated ulcerative colitis (UC) patients. PATIENTS AND METHODS This was a UK-based, multi-centre, prospective, real-world, non-interventional pilot study. Eligible patients completed PRO2 scores at baseline and every 4 weeks over a period of 6 months. Demographics were collected at baseline and a satisfaction questionnaire was completed at study end. Each patient provided data anonymously via an online platform. RESULTS Fifty-two patients enrolled in the study. Mean (SD) patient age was 40.8 (13.6); 52% were male. Patients provided data on a personal computer (44%), mobile phone (38%) or tablet (18%). Forty-seven (90%) patients completed the baseline questionnaire within the accepted time range. Subsequent scores were reported on time by eligible patients with a success rate of 94%, 92%, 90%, 87%, 90% and 81% at end of months 1-6, respectively. CONCLUSIONS Remote monitoring of PRO2 in UC was feasible amongst the sample tested. Of those initially willing to provide data in this way, attrition was low. Formal roll-out of this system could be used to support a more frequent assessment of UC symptoms without over-burdening the healthcare system.
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Affiliation(s)
- Shaji Sebastian
- IBD Unit, Hull and East Yorkshire Hospital NHS Trust, Hull, UK
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