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Effectiveness and Safety of Vedolizumab Induction Therapy for Patients with Inflammatory Bowel Disease

Aurelien Amiot 1, 2 Jean-Charles Grimaud 3 Laurent Peyrin-Biroulet 4 Jérome Filippi 5 Benjamin Pariente 6 Xavier Roblin 7 Anthony Buisson 8 Carmen Stefanescu 9, 10 Caroline Trang-Poisson 11 Romain Altwegg 12 Philippe Marteau 13 Thibaud Vaysse 14 Anne Bourrier 15, 16 Stéphane Nancey 17, 18 David Laharie 19 Matthieu Allez 20 Guillaume Savoye 21, 22, 23 Jacques Moreau 24 Charlotte Gagniere 1, 2 Lucine Vuitton 25 Stephanie Viennot 26 Alexandre Aubourg 27, 28 Anne-Laure Pelletier 29 Guillaume Bouguen 30, 31, 32 Vered Abitbol 33 Yoram Bouhnik 9, 10 Camille Zallot 4 Marc-André Bigard 4 Xavier Hebuterne 34, 5 Maria Nachury 35 Pierre Desreumaux 6, 36, 37 Emilie del Tedesco 38 Gilles Bommelaer 36 Arnaud Boureille 39 Xavier Dray 40, 13 Franck Carbonnel 41 Philippe Seksik 42 Laurent Beaugerie 42 Jacques Cosnes 15, 16 Harry Sokol 42 Cecilia Landman 15, 16 Gilles Boschetti 43 Florian Poullenot 44 Jean-Marc Gornet 20 Clautilde Baudry 45 Stéphane Koch 46 Laurence Picon 47 Gaelle Sickersen 48 Stanislas Chaussade 49 Stephane Nahon 50 Betsy Winkfield 51, 52 Hedia Brixi-Benmansour 52 Rodica Gincul 53 Jean-Christophe Barberis 51 Bruno Bonaz 54 Christophe Michiels 51 Franck Zerbib 19 Marie Beauregard 51 Christophe Locher 55 Sophie Davin-Couve 51 Armelle Poirette 51 Laurence Guillem 51 Monica Stetiu-Mocanu 51 Sylvain Beorchia 51 Jawad Al Qaddi 51
40 ASTRE [Cergy-Pontoise]
ETIS - UMR 8051 - Equipes Traitement de l'Information et Systèmes
54 Stress et Interactions neuro-digestives
GIN - [GIN] Grenoble Institut des Neurosciences
Abstract : Background & aims - Phase 3 trials have shown the efficacy of vedolizumab, which binds to integrin α4β7, in patients with Crohn's disease (CD) or ulcerative colitis (UC). We investigated the effectiveness and safety of vedolizumab in patients who failed anti-tumor necrosis factor therapy. Methods - From June through December 2014, there were 173 patients with CD and 121 patients with UC who were included in a multicenter nominative compassionate early access program granted by French regulatory agencies. This program provided patients with access to vedolizumab before it was authorized for marketing. Vedolizumab (300 mg) was administered intravenously at weeks 0, 2, and 6, and then every 8 weeks. Disease activity was assessed using the Harvey-Bradshaw Index for CD and the partial Mayo Clinic score for UC. We report results obtained after the 14-week induction phase. Results - Among the 294 patients treated with vedolizumab (mean age, 39.5 ± 14.0 y; mean disease duration, 10.8 ± 7.6 y; concomitant steroids, 44% of cases), 276 completed the induction period, however, 18 discontinued vedolizumab because of a lack of response (n = 14), infusion-related reaction (n = 2), or infections (n = 2). At week 14, 31% of patients with CD were in steroid-free clinical remission and 51% had a response; among patients with UC, 36% were in steroid-free clinical remission and 50% had a response. No deaths were reported. Severe adverse events occurred in 24 patients (8.2%), including 15 (5.1%) that led to vedolizumab discontinuation (1 case of pulmonary tuberculosis and 1 rectal adenocarcinoma). Conclusions - In a cohort of patients with CD or UC who failed previous anti-tumor necrosis factor therapy, approximately one third of patients achieved steroid-free clinical remission after 14 weeks of induction therapy with vedolizumab. This agent had an acceptable safety profile in these patients.
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Submitted on : Wednesday, February 24, 2016 - 3:33:37 PM
Last modification on : Thursday, September 2, 2021 - 3:27:41 AM

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Aurelien Amiot, Jean-Charles Grimaud, Laurent Peyrin-Biroulet, Jérome Filippi, Benjamin Pariente, et al.. Effectiveness and Safety of Vedolizumab Induction Therapy for Patients with Inflammatory Bowel Disease. Clinical Gastroenterology and Hepatology, WB Saunders, 2016, 14 (11), pp.1593-1601.e2. ⟨10.1016/j.cgh.2016.02.016⟩. ⟨hal-01278611⟩

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