期刊
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
卷 44, 期 11-12, 页码 1199-1212出版社
WILEY
DOI: 10.1111/apt.13813
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资金
- AbbVie
- Biogen
- Janssen
- MSD
- Mundipharma
- Takeda
- FalkFoundation
- Pentax
- Index Pharmaceuticals AB
- Falk Foundation
- Allergosan
- Ferring
- Hexal
- Hospira
- Pharmacosmos
- Vifor
- Braun and Bayer Technology services
- Boston Scientific
- GWT TUD
- Falk
- MSD Sharp Dohme GmbH
- PPM Services S.A.
- Boehringer Ingelheim GmbH Co. KG
- Janssen Cilag GmbH
- Pentax Europe GmbH
- e.Bavarian Health GmbH
- Takeda Pharma GmbH
- AbbVie GmbH Co. KG
- Hexal AG
- German Research Council
- German Cancer Aid
- Pfizer
- Merck
- Shire
- Merckle
BackgroundVedolizumab, a monoclonal antibody targeting the 47-integrin, is effective in inducing and maintaining clinical remission in Crohn's disease and ulcerative colitis according to randomised clinical trials. AimTo determine the long-term effectiveness of vedolizumab in a real-world clinical setting. MethodsThis observational registry assessed the clinical outcome in patients treated with vedolizumab for clinically active Crohn's disease (n = 67) or ulcerative colitis (n = 60). Primary endpoint was clinical remission (HBI 4/pMayo 1) at week 54. Secondary endpoints included clinical response rates (HBI/pMayo score drop 3) and steroid-free clinical remission at weeks 30 and 54. ResultsVedolizumab was stopped in 69/127 (56%) patients after a median time of 18 weeks (range 2-49) predominantly owing to lack or loss of response. Using nonresponder imputation analysis, clinical remission and steroid-free remission rates were 21% and 15% in Crohn's disease and 25% and 22% in ulcerative colitis, respectively. Lack of clinical remission was associated with prior treatment with anti-TNF or with steroids for more than 3 months in the last 6 months in ulcerative colitis. At week 14, the absence of remission in Crohn's disease or nonresponse in ulcerative colitis indicated a low likelihood of clinical remission at week 54 [2/31 (7%) in Crohn's disease, 4/41 (10%) in ulcerative colitis]. Accordingly, declining C-reactive protein in inflammatory bowel disease and/or lower faecal calprotectin in ulcerative colitis at week 14 predicted remission at week 54. ConclusionAmong patients who started vedolizumab for active inflammatory bowel disease, clinical remission rates are 21-25% after 54 weeks.
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