Three‐year effectiveness and safety of vedolizumab therapy for inflammatory bowel disease: a prospective multi‐centre cohort study. Issue 1 (5th June 2019)

• Record Type: Journal Article
• Authors: Amiot, Aurelien; Serrero, Melanie; Peyrin‐Biroulet, Laurent; Filippi, Jerome; Pariente, Benjamin; Roblin, Xavier; Buisson, Anthony; Stefanescu, Carmen; Trang‐Poisson, Caroline; Altwegg, Romain; Marteau, Philippe; Vaysse, Thibaud; Bourrier, Anne; Nancey, Stephane; Laharie, David; Allez, Matthieu; Savoye, Guillaume; Moreau, Jacques; Vuitton, Lucine; Viennot, Stephanie; Bouguen, Guillaume; Abitbol, Vered; Fumery, Mathurin; Gagniere, Charlotte; Bouhnik, Yoram
• Other Names: Grimaud Jean‐Charles investigator.; Zallot Camille investigator.; Bigard Marc‐Andre investigator.; Hebuterne Xavier investigator.; Nachury Maria investigator.; Desreumaux Pierre investigator.; Del Tedesco Emilie investigator.; Bommelaer Gilles investigator.; Boureille Arnaud investigator.; Dray Xavier investigator.; Carbonnel Franck investigator.; Seksik Philippe investigator.; Beaugerie Laurent investigator.; Cosnes Jacques investigator.; Sokol Harry investigator.; Landman Cecilia investigator.; Boschetti Gilles investigator.; Poullenot Florian investigator.; Gornet Jean‐Marc investigator.; Baudry Clautilde investigator.; Koch Stephane investigator.; Aubourg Alexandre investigator.; Picon Laurence investigator.; Pelletier Anne‐Laure investigator.; Sickersen Gaelle investigator.; Chaussade Stanislas investigator.; Nahon Stephane investigator.; Winkfield Betsy investigator.; Brixi‐benmansour Hedia investigator.; Gincul Rodica investigator.; Barberis Jean‐Christophe investigator.; Bonaz Bruno investigator.; Michiels Christophe investigator.; Zerbib Franck investigator.; Bourrier de Beauregard Marie investigator.; Locher Christophe investigator.; Davin‐Couve Sophie investigator.; Poirette Armelle investigator.; Guillem Laurence investigator.; Stetiu‐Mocanu Monica investigator.; Philippe Beau investigator.; Beorchia Sylvain investigator.; Al Qaddi Jawad investigator.; Amiot Aurelien investigator.; Gagniere Charlotte investigator.; Serrero Melanie investigator.; Peyrin‐Biroulet Laurent investigator.; Filippi Jerome investigator.; Pariente Benjamin investigator.; Roblin Xavier investigator.; Buisson Anthony investigator.; Stefanescu Carmen investigator.; Bouhnik Yoram investigator.; Trang‐Poisson Caroline investigator.; Altwegg Romain investigator.; Marteau Philippe investigator.; Vaysse Thibaud investigator.; Bourrier Anne investigator.; Nancey Stephane investigator.; Laharie David investigator.; Poullenot Florian investigator.; Allez Matthieu investigator.; Savoye Guillaume investigator.; Moreau Jacques investigator.; Vuitton Lucine investigator.; Viennot Stephanie investigator.; Aubourg Alexandre investigator.; Picon Laurence investigator.; Bouguen Guillaume investigator.; Abitbol Vered investigator.; Fumery Mathurin investigator.; Winkfield Betsy investigator.; Brixi‐benmansour Hedia investigator.; Gincul Rodica investigator.;
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 50:Issue 1(2019)
• Page Start: 40
• Page End: 53
• Publication Date: 2019-06-05
• Subjects: Crohn's disease -- inflammatory bowel disease -- ulcerative colitis -- vedolizumab; Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.15294
• Languages: English
• ISSNs: 0269-2813

Abstract

Summary: Background: Cohort studies have described the short‐term effectiveness and safety of vedolizumab in treating patients with Crohn's disease (CD) and ulcerative colitis (UC), but data beyond 1 year are lacking. Aim: To assess the effectiveness and safety of vedolizumab after 162 weeks in patients with UC and CD. Methods: Between June and December 2014, 294 patients including 173 patients with CD and 121 with UC were treated with vedolizumab induction therapy. Among them, 149 continued to be treated with vedolizumab beyond week 54 (78 patients with CD and 71 with UC). Disease activity was assessed using the Harvey‐Bradshaw Index for CD and the partial Mayo Clinic score for UC. The primary outcome was steroid‐free clinical remission at week 162, computed for the whole population included at week 0. Results: Steroid‐free clinical remission rates at week 162 were 19.9% and 36.1% in patients with CD and UC respectively. Vedolizumab dose optimisation to 300 mg every 4 weeks instead of 300 mg every 8 weeks was at investigator's discretion and occurred in 58.7% and 52.1% of patients with CD and UC respectively. The 1‐, 2‐ and 3‐year persistence rates of vedolizumab were 48.5%, 31.4% and 26.3% respectively, in patients with CD and 61.0%, 49.9% and 42.9% respectively, in patients with UC. No new safety signal was identified. Conclusion: Vedolizumab is able to maintain steroid‐free clinical remission in patients with UC and CD up to week 162. Loss of response resulting in discontinuation of vedolizumab occurred in 10% of patients per year.