1. Real-World Evidence of Effectiveness and Safety of Vedolizumab for Inflammatory Bowel Disease in Taiwan: A Prospective Nationwide Registry (VIOLET) Study.
- Author
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Lin WC, Tai WC, Chang CH, Tu CH, Feng IC, Shieh MJ, Chung CS, Yen HH, Chou JW, Wong JM, Liu YH, Huang TY, Chuang CH, Tsai TJ, Chiang FF, Lu CY, Hsu WH, Yu FJ, Chao TH, Wu DC, Ho AS, Lin HH, Feng CL, Wu KL, Wong MW, Tung CC, Lin CC, Chen CC, Hu HM, Lu LS, Wang HS, Wu IC, Kuo HY, Wu JF, Yao Shih H, Ni YH, Tang SL, Chen PH, and Wei SC
- Subjects
- Humans, Taiwan, Remission Induction, Gastrointestinal Agents therapeutic use, Recurrence, Treatment Outcome, Retrospective Studies, Inflammatory Bowel Diseases drug therapy, Colitis, Ulcerative drug therapy, Crohn Disease drug therapy, Hepatitis B
- Abstract
Background: This nationwide prospective registry study investigated the real-world effectiveness, safety, and persistence of vedolizumab (VDZ) in inflammatory bowel disease (IBD) patients in Taiwan. Disease relapse rates after VDZ discontinuation due to reimbursement restriction were assessed., Methods: Data were collected prospectively (January 2018 to May 2020) from the Taiwan Society of IBD registry., Results: Overall, 274 patients (147 ulcerative colitis [UC] patients, 127 Crohn's disease [CD] patients) were included. Among them, 70.7% with UC and 50.4% with CD were biologic-naïve. At 1 year, 76.0%, 58.0%, 35.0%, and 62.2% of UC patients and 57.1%, 71.4%, 33.3%, and 30.0% of CD patients achieved clinical response, clinical remission, steroid-free remission, and mucosal healing, respectively. All patients underwent hepatitis B and tuberculosis screening before initiating biologics, and prophylaxis was recommended when necessary. One hepatitis B carrier, without antiviral prophylaxis due to economic barriers, had hepatitis B reactivation during steroid tapering and increasing azathioprine dosage, which was controlled with an antiviral agent. No tuberculosis reactivation was noted. At 12 months, non-reimbursement-related treatment persistence rates were 94.0% and 82.5% in UC and CD patients, respectively. Moreover, 75.3% of IBD patients discontinued VDZ due to mandatory drug holiday. Relapse rates after VDZ discontinuation at 6 and 12 months were 36.7% and 64.3% in CD patients and 42.9% and 52.4% in UC patients, respectively., Conclusions: The findings demonstrated VDZ effectiveness in IBD patients in Taiwan, with high treatment persistence rates and favorable safety profiles. A substantial IBD relapse rate was observed in patients who had mandatory drug holiday., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2023
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