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

Expert Opin Drug Saf. 2023 Jul-Dec;22(9):767-776.doi: 10.1080/14740338.2023.2247976. Epub 2023 Aug 23.


Sailish Honap 1 2Patrick Netter 3Silvio Danese 4Laurent Peyrin-Biroulet 5 6 7 8


Author information

1Department of Gastroenterology, St George's University Hospitals NHS Foundation Trust, London, UK.

2School of Immunology and Microbial Sciences, King's College London, London, UK.

3Ingénierie Moléculaire et Ingénierie Articulaire (IMoPA), UMR-7365 CNRS, Faculté de Médecine, University of Lorraine and University Hospital of Nancy, Nancy, France.

4Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy.

5Department of Gastroenterology, Nancy University Hospital, Vandœuvre-lès-Nancy, France.

6INFINY Institute, Nancy University Hospital, Vandœuvre-lès-Nancy, France.

7Groupe Hospitalier privé Ambroise Paré - Hartmann, Paris IBD center, Neuilly sur Seine, France.

8Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.


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.

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