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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 Marc-André Bigard 4 Xavier Hebuterne 34, 5 Maria Nachury Pierre Desreumaux 6, 35, 36 Emilie del Tedesco Gilles Bommelaer 35 Arnaud Boureille 37 Xavier Dray 38, 13 Franck Carbonnel Philippe Seksik 39 Laurent Beaugerie 39 Jacques Cosnes 15, 16 Harry Sokol 39 Cecilia Landman 15, 16 Gilles Boschetti Florian Poullenot Jean-Marc Gornet Clautilde Baudry Stéphane Koch Laurence Picon Gaelle Sickersen Stanislas Chaussade Stephane Nahon Betsy Winkfield Hedia Brixi-Benmansour Rodica Gincul 40 Jean-Christophe Barberis Bruno Bonaz 41 Christophe Michiels Franck Zerbib 19 Marie Beauregard Christophe Locher 42 Sophie Davin-Couve Armelle Poirette Laurence Guillem Monica Stetiu-Mocanu Sylvain Beorchia Jawad Al Qaddi
38 ASTRE [Cergy-Pontoise]
ETIS - UMR 8051 - Equipes Traitement de l'Information et Systèmes
41 Equipe 8 : Stress et Interactions neuro-digestives
UJF - Université Joseph Fourier - Grenoble 1, CEA - Commissariat à l'énergie atomique et aux énergies alternatives, INSERM - Institut National de la Santé et de la Recherche Médicale : U836, [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 : Wednesday, October 14, 2020 - 3:50:36 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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