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

Aurelien Amiot; Jean-Charles Grimaud; Laurent Peyrin-Biroulet; Jérome Filippi; Benjamin Pariente; Xavier Roblin; Anthony Buisson; Carmen Stefanescu; Caroline Trang-Poisson; Romain Altwegg; Philippe Marteau; Thibaud Vaysse; Anne Bourrier; Stéphane Nancey; David Laharie; Matthieu Allez; Guillaume Savoye; Jacques Moreau; Charlotte Gagniere; Lucine Vuitton; Stephanie Viennot; Alexandre Aubourg; Anne-Laure Pelletier; Guillaume Bouguen; Vered Abitbol; Yoram Bouhnik; Camille Zallot; Marc-André Bigard; Xavier Hebuterne; Maria Nachury; Pierre Desreumaux; Emilie del Tedesco; Gilles Bommelaer; Arnaud Boureille; Xavier Dray; Franck Carbonnel; Philippe Seksik; Laurent Beaugerie; Jacques Cosnes; Harry Sokol; Cecilia Landman; 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; Jean-Christophe Barberis; Bruno Bonaz; Christophe Michiels; Franck Zerbib; Marie Bourrier De Beauregard; Christophe Locher; Sophie Davin-Couve; Armelle Poirette; Laurence Guillem; Monica Stetiu-Mocanu; Sylvain Beorchia; Jawad Al Qaddi

doi:10.1016/j.cgh.2016.02.016

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

Journal article

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

Aurelien Amiot, Jean-Charles Grimaud, Laurent Peyrin-Biroulet, Jérome Filippi, Benjamin Pariente, Xavier Roblin, Anthony Buisson, Carmen Stefanescu, Caroline Trang-Poisson, Romain Altwegg, …

Clinical Gastroenterology and Hepatology, Vol.14(11), pp.1593-1601.e2

11/2016

DOI: https://doi.org/10.1016/j.cgh.2016.02.016

PMID: 26917043

Abstract

drug

inhibitor

cell adhesion

IBD

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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Title: Effectiveness and Safety of Vedolizumab Induction Therapy for Patients with Inflammatory Bowel Disease
Creators - without role: Aurelien Amiot - Centre Hospitalier Universitaire Henri-Mondor
Jean-Charles Grimaud - Aix-Marseille Université
Laurent Peyrin-Biroulet - Nutrition-Génétique et Exposition aux Risques Environnementaux
Jérome Filippi - Centre Hospitalier Universitaire de Nice
Benjamin Pariente - Centre Hospitalier Universitaire de Lille
Xavier Roblin - Centre Hospitalier Universitaire de Saint-Étienne
Anthony Buisson - Centre Hospitalier Universitaire de Clermont-Ferrand
Carmen Stefanescu - Hôpital Beaujon
Caroline Trang-Poisson - Digestive Health Research Institute
Romain Altwegg - Hôpital Saint Eloi
Philippe Marteau - Assistance Publique – Hôpitaux de Paris
Thibaud Vaysse - Bicêtre Hospital
Anne Bourrier - Hôpital Saint-Antoine
Stéphane Nancey - Université Claude Bernard Lyon 1
David Laharie - Service d'Hépato-Gastro-Entérologie
Matthieu Allez - Hôpital Saint-Louis
Guillaume Savoye - Institute for Research and Innovation in Biomedicine
Jacques Moreau - Centre Hospitalier Universitaire de Toulouse
Charlotte Gagniere - Early detection of Colon Cancer using Molecular Markers and Microbiota
Lucine Vuitton - Centre Hospitalier Universitaire de Besançon
Stephanie Viennot - Université de Caen Normandie
Alexandre Aubourg - Centre National de la Recherche Scientifique
Anne-Laure Pelletier - Hôpital Bichat-Claude-Bernard
Guillaume Bouguen - Centre Hospitalier Universitaire de Rennes
Vered Abitbol - Hôpital Cochin
Yoram Bouhnik - Hôpital Beaujon
Camille Zallot - Nutrition-Génétique et Exposition aux Risques Environnementaux
Marc-André Bigard - Nutrition-Génétique et Exposition aux Risques Environnementaux
Xavier Hebuterne - Centre Hospitalier Universitaire de Nice
Maria Nachury - Hôpital Claude Huriez
Pierre Desreumaux - Université de Lille
Emilie del Tedesco - Centre Hospitalier Universitaire de Saint-Étienne
Gilles Bommelaer - Inserm
Arnaud Boureille - The Enteric Nervous System in Gut and Brain Disorders
Xavier Dray - Assistance Publique – Hôpitaux de Paris
Franck Carbonnel - Bicêtre Hospital
Philippe Seksik - Charmo University
Laurent Beaugerie - Assistance Publique – Hôpitaux de Paris
Jacques Cosnes - Sorbonne Université
Harry Sokol - Hôpital Saint-Antoine
Cecilia Landman - Hôpital Saint-Antoine
Gilles Boschetti - Service d'Hépatologie et de Gastroentérologie [Lyon]
Florian Poullenot - Hôpital Cardiologique du Haut-Lévêque
Jean-Marc Gornet - Hôpital Saint-Louis
Clautilde Baudry - Hôpital Avicenne
Stéphane Koch - Linköping University
Laurence Picon - Centre Hospitalier Universitaire de Tours
Gaelle Sickersen - Hôpital Saint-Louis
Stanislas Chaussade - Hôpital Cochin
Stephane Nahon - Groupe Hospitalier Intercommunal Le Raincy Montfermeil
Betsy Winkfield - Groupe d'Étude Thérapeutique des Affections Inflammatoires du Tube Digestif
Hedia Brixi-Benmansour - Groupe d'Étude Thérapeutique des Affections Inflammatoires du Tube Digestif
Rodica Gincul - Hôpital Edouard Herriot
Jean-Christophe Barberis - Observatory on Efficacy and of Vedolizumab in Patients With Inflammatory Bowel Disease Study Group
Bruno Bonaz - Montreal Neurological Institute and Hospital
Christophe Michiels - Observatory on Efficacy and of Vedolizumab in Patients With Inflammatory Bowel Disease Study Group
Franck Zerbib - Service d'Hépato-Gastro-Entérologie
Marie Bourrier De Beauregard - Observatory on Efficacy and of Vedolizumab in Patients With Inflammatory Bowel Disease Study Group
Christophe Locher - Centre Hospitalier de Meaux
Sophie Davin-Couve - Observatory on Efficacy and of Vedolizumab in Patients With Inflammatory Bowel Disease Study Group
Armelle Poirette - Observatory on Efficacy and of Vedolizumab in Patients With Inflammatory Bowel Disease Study Group
Laurence Guillem - Observatory on Efficacy and of Vedolizumab in Patients With Inflammatory Bowel Disease Study Group
Monica Stetiu-Mocanu - Observatory on Efficacy and of Vedolizumab in Patients With Inflammatory Bowel Disease Study Group
Sylvain Beorchia - Observatory on Efficacy and of Vedolizumab in Patients With Inflammatory Bowel Disease Study Group
Jawad Al Qaddi - Observatory on Efficacy and of Vedolizumab in Patients With Inflammatory Bowel Disease Study Group
Publication Details: Clinical Gastroenterology and Hepatology, Vol.14(11), pp.1593-1601.e2
Identifiers: 9934892209311
Academic Unit: Université de Montpellier
Language: English
Resource Type: Journal article
Local Fields: hal-01278611