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.


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.

Keywords: Crohn’s disease; Inflammatory bowel disease; cancer; pregnancy; safety; surgery; ulcerative colitis; vedolizumab.

Publication types

  • Review

MeSH terms

  • Aged
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Child
  • Colitis, Ulcerative* / drug therapy
  • Gastrointestinal Agents / adverse effects
  • Humans
  • Inflammatory Bowel Diseases* / chemically induced
  • Inflammatory Bowel Diseases* / drug therapy
  • Observational Studies as Topic


  • vedolizumab
  • Gastrointestinal Agents
  • Antibodies, Monoclonal, Humanized