Vedolizumab: A Review of Its Use in Adult Patients with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease

Abstract

Vedolizumab (Entyvio™) is a humanized monoclonal antibody α4β7 integrin-receptor antagonist indicated for the treatment of adult patients with moderately to severely active ulcerative colitis or Crohn's disease. This article reviews the pharmacological properties of intravenous infusions of vedolizumab and its clinical efficacy in adult patients with these diseases. In phase III clinical trials, patients with ulcerative colitis had significantly higher rates of clinical response and clinical remission when treated with vedolizumab than when receiving placebo at both 6 and 52 weeks. However, outcomes with vedolizumab in patients with Crohn's disease were mixed. In a study that evaluated both clinical remission rate and CDAI-100 response rate as primary endpoints, only the clinical remission rate at 6 weeks was significantly higher with vedolizumab than placebo. In another trial, there was no significant between-group difference in the clinical remission rate in TNF-antagonist failure patients at 6 weeks (primary endpoint), although there was a significant difference at 10 weeks. In the Crohn's disease study that included maintenance treatment, vedolizumab was significantly more effective at 52 weeks than placebo in both endpoints (clinical remission was the only primary endpoint in the maintenance study). Vedolizumab was generally well tolerated in these trials. As vedolizumab is a specific α4β7 integrin antagonist, with gut-specific effects, it is unlikely to be associated with the development of progressive multifocal leukoencephalopathy, a risk observed with the less selective α4β7/α4β1 integrin antagonist natalizumab. Vedolizumab is a useful addition to the treatment options available for patients with moderately to severely active ulcerative colitis and Crohn's disease.

Role of biologics and biosimilars in inflammatory bowel disease: current trends and future perspectives

“… 58 The CD trials included the GEMINI II and GEMINI III, which showed mixed results of efficacy. 59 At week 6 in GEMINI II RCT, clinical remission was seen in 14.5% who received vedolizumab and 6.8% who received placebo and clinical response was seen in 31.4% who received vedolizumab and 25.7% who received placebo ( P =0.23). Among patients who responded to induction therapy, 39.0% and 36.4% of those who received vedolizumab 8- and 4-weekly, respectively, were in clinical remission at week 52% versus 21.6% of those who received placebo ( P <0.001 and 0.004, respectively, for the two vedolizumab groups versus placebo).…”

The safety of vedolizumab for ulcerative colitis and Crohn's disease

“… 1 Vedolizumab is a gut-selective, humanised monoclonal antibody targeting α 4 β 7 integrin. 2 3 Clinical studies have demonstrated a positive benefit-risk profile of vedolizumab in adult patients with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD). 4–6 No major differences in safety profiles were observed between placebo-treated and vedolizumab-treated patients.…”

Long-term Efficacy of Vedolizumab for Ulcerative Colitis

“…6,7 Vedolizumab, a monoclonal antibody specifically targeting the α 4 β 7 integrin heterodimer, is a new treatment for moderately to severely active UC. 8 Distinct from TNF antagonists and thiopurines, vedolizumab selectively inhibits binding of the α 4 β 7 integrin to mucosal addressin cell adhesion molecule-1 [MAdCAM-1], which is preferentially expressed in the intestinal endothelium. 9 Blockade of the α 4 β 7 integrin-MAdCAM-1 interaction interferes with migration of inflammatory cells into the gastrointestinal tract.…”