An update on the safety of long-term vedolizumab use in inflammatory bowel disease

Sailish Honap, Patrick Netter, Silvio Danese, Laurent Peyrin-Biroulet

Research output: Contribution to journalReview articlepeer-review

3 Citations (Scopus)
25 Downloads (Pure)


Introduction: Vedolizumab (Entyvio) is a humanized monoclonal antibody that disrupts the interaction between α4β7 integrin on circulating T-lymphocytes and MAdCAM-1 on the vascular endothelium to prevent their egress to sites of gut inflammation. It has proven therapeutic efficacy for the treatment of moderate-to-severe Crohn's disease, ulcerative colitis, and pouchitis.

Areas Covered: This narrative review assesses the safety profile of vedolizumab from the registration trial programs, open-label extension studies, observational real-world data, and pooled safety analyses. This includes an evaluation of the long-term overall safety in special populations typically underrepresented in clinical trials.

Expert Opinion: Vedolizumab is an effective therapy for inflammatory bowel disease with a well-established safety profile. No unexpected long-term safety signals have been identified. Safety data in pregnancy, in pediatric and elderly populations, in patients undergoing surgery, and in patients with a prior history of cancer are reassuring. Due to its safety merits, we propose that vedolizumab is an excellent candidate for advanced combination treatment with an anti-cytokine approach using another biologic or novel small molecule inhibitor. This is important in patients with medically refractory IBD, in patients at high risk of developing disease-related complications, or in patients with concomitant uncontrolled immune-mediated inflammatory diseases.

Original languageEnglish
Pages (from-to)767-776
Number of pages10
JournalExpert Opinion On Drug Safety
Issue number9
Early online date23 Aug 2023
Publication statusPublished - 2023


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