Three-year Effectiveness and Safety of Vedolizumab Therapy for Inflammatory Bowel Disease

A Prospective Multi-centre Cohort Study

Aurelien Amiot; Melanie Serrero; 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; Lucine Vuitton; Stephanie Viennot; Guillaume Bouguen; Vered Abitbol; Mathurin Fumery; Charlotte Gagniere; Yoram Bouhnik; on the behalf of the OBSERV-IBD study group, the GETAID


Aliment Pharmacol Ther. 2019;50(1):40-53. 

In This Article

Abstract and Introduction


Background: Cohort 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.

Aim: To assess the effectiveness and safety of vedolizumab after 162 weeks in patients with UC and CD.

Methods: Between 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.

Results: Steroid-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.

Conclusion: Vedolizumab 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.


Vedolizumab is a fully humanized monoclonal antibody that prevents gut-homing from the blood to the gastrointestinal tract of a subtype of leucocytes expressing the α4β7 integrin.[1] Vedolizumab inhibits the binding of α4β7 integrin with the mucosal addressin cell adhesion molecule-1 (MAdCAM–1) in a gut-specific manner, preventing systemic immunosuppression.[2] Vedolizumab has demonstrated its efficacy and safety in the treatment of both ulcerative colitis (UC) and Crohn's disease (CD) based on the results of three pivotal phase 3 clinical trials.[3–5] In addition, long-term open-label studies (GEMINI-LTS) that included patients from clinical trials treated with vedolizumab indicated that the effectiveness of vedolizumab remained stable after 3 years of follow-up in patients who responded to vedolizumab induction.[6,7]

Since 2014, many cohort studies and two systematic reviews have confirmed the effectiveness and safety of vedolizumab in treating patients with UC and CD.[8,9] Those studies are highly interesting since clinical trials can be different from real-life due to patients who would not fulfil inclusion criteria and patients being unwilling to accept placebo control.[3–5] The optimal timing for assessment of clinical response/remission was week 14, which was delayed compared with week 6-8 for anti-TNF agents.[10,11] Patients with lower disease activity according to clinical scores and/or CRP levels had greater likelihood of responding to vedolizumab.[10–14] Real-world safety data reported no new or unexpected safety signals, especially in elderly patients and patients with penetrating disease.[8,9] However, there are no data on long-term outcomes of patients with IBD treated with vedolizumab.

The OBSERV-IBD cohort has been set up on a prospective basis through a nominative, compassionate early access programme from the French regulatory agency, Agence Nationale de Sécurité du Medicaments et des produits de santé (ANSM), from June to December 2014 that provided access to vedolizumab for IBD patients before marketing authorisation was granted.[15] We previously reported the effectiveness and safety of vedolizumab in patients in this cohort at weeks 14 and 52. Here, we report the effectiveness and safety of vedolizumab maintenance therapy after 3 years (at week 162) in patients with moderate-to-severe active UC and CD who failed to respond to anti-TNF therapy.