Aurélien Amiot1, Mélanie Serrero2, Laurent Beaugerie3, Philippe Marteau4, Benjamin Pariente5, Xavier Roblin6, Anthony Buisson7, Gilles Boschetti8, Caroline Trang-Poisson9, Romain Altwegg10, T. Vaysse11, Julien Kirchgesner12, Stéphane Nancey13, David Laharie14, Matthieu Allez15, Guillaume Savoye16,17, Jacques Moreau18, Lucine Vuitton19, Stéphanie Viennot20, Guillaume Bouguen21, Véred Abitbol15, Mathurin Fuméry22, Charlotte Gagnière1, Yoram Bouhnik8, Groupe d'Etude Thérapeutique Des Affections Getaid23
1Creteil, France
2Marseille – France
3Nancy – France
4CHU Nice - Centre Hospitalier Universitaire de Nice (30, Voie Romaine
CS 51069 - 06001 Nice Cedex 1 - France)
5Lille – France
6Saint‐Etienne France
7Clermont‐Ferrand France
8Clichy – France
9CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital (1 Place Alexis-Ricordeau, 44000 Nantes - France)
10CHU Montpellier (371, avenue du Doyen Gaston Giraud 34295 MONTPELLIER cedex 5 - France)
11Kremlin Bicêtre France
12CHU Saint-Antoine [AP-HP] (184, rue du Faubourg Saint-Antoine
75571 Paris cedex 12 - France)
13Lyon – France
14Bordeaux – France
15Paris – France
16ADEN - Nutrition, inflammation et dysfonctionnement de l'axe intestin-cerveau (22 bd Gambetta
76183 Rouen Cedex - France)
17IRIB - Institute for Research and Innovation in Biomedicine (22 Boulevard Gambetta
76183 Rouen Cedex - France)
18Toulouse, France.
19Besançon – France
20Caen – France
21Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou] (2 Rue Henri le Guilloux, 35000 Rennes - France)
22Amiens – France
23GETAID - Groupe d’Étude Thérapeutique des Affections Inflammatoires du Tube Digestif (50 rue Richer, 75009 Paris - France)
Tóm tắt
SummaryBackgroundCohort 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.AimTo assess the effectiveness and safety of vedolizumab after 162 weeks in patients with UC and CD.MethodsBetween 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.ResultsSteroid‐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.ConclusionVedolizumab 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.
