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.