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

Sailish Honap ^1 2, Patrick Netter ³, Silvio Danese ⁴, Laurent 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.

Abstract

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.