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

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.

• Authors: Aurelien Amiot, Jean-Charles Grimaud, Laurent Peyrin-Biroulet, Jerome Filippi, Benjamin Pariente, Xavier Roblin, Anthony Buisson, Carmen Stefanescu, Caroline Trang-Poisson, Romain Altwegg, Philippe Marteau, Thibaud Vaysse, Anne Bourrier, Stephane 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, Observatory on Efficacy and of Vedolizumab in Patients With Inflammatory Bowel Disease Study Group, Groupe d'Etude Therapeutique des Affections Inflammatoires du tube Digestif
• Journal: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (Clin Gastroenterol Hepatol) Vol. 14 Issue 11 Pg. 1593-1601.e2 (11 2016) ISSN: 1542-7714 [Electronic] United States
• PMID: 26917043 (Publication Type: Journal Article, Multicenter Study)
• Copyright: Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.

Chemical References

• Antibodies, Monoclonal, Humanized
• Gastrointestinal Agents
• vedolizumab

Topics

• Administration, Intravenous
• Adolescent
• Adult
• Aged
• Antibodies, Monoclonal, Humanized (adverse effects, therapeutic use)
• Drug-Related Side Effects and Adverse Reactions (epidemiology, pathology)
• Female
• Gastrointestinal Agents (adverse effects, therapeutic use)
• Humans
• Inflammatory Bowel Diseases (drug therapy, pathology)
• Male
• Middle Aged
• Prospective Studies
• Treatment Outcome
• Young Adult