For both tumor necrosis factor (TNF)-naïve and TNF-failure patients with ulcerative colitis (UC), compared to placebo, treatment with vedolizumab showed a high response and maintenance remission rate in a Phase 3 trial analysis.
Researchers evaluated the outcomes of the GEMINI Phase 3 trial of vedolizumab in 831 patients with moderately to severely acute UC; 464 of the patients had no prior TNF therapy and 367 had failed the therapy because of inadequate response, loss of response or intolerance. Those enrolled were randomized to either placebo or vedolizumab.
Results showed that the response rate with vedolizumab for the treatment naïve patients was 53.1% compared to 26.3% for placebo, after 6 weeks (95% CI: 12.4, 40.4; RR: 2.0; 95% CI: 1.3, 3.0). After 52 weeks the remission rate was 46.9% for the vedolizumab group compared to 19.0% for the placebo group (95% CI: 14.9, 41.1; RR: 2.5; 95% CI: 1.5, 4.0).
In the participants who failed TNF therapy, vedolizumab also showed a high response and remission rates. After 6 weeks the response rate was 39.0% compared to 20.6% in the placebo group (95% CI: 2.8, 33.5; RR: 1.9; 95% CI: 1.1, 3.2), while after 52 weeks the remission rate was 36.1% compared to 5.3% in the placebo group (95% CI: 12.8, 46.1; RR: 6.6; 95% CI: 1.7, 26.5).
“Approximately 50% of patients with ulcerative colitis do not respond to TNF antagonist therapy, or lose response over time,” said Brian Feagan, MD, University of Western Ontario in London, and lead author of the analysis. “These efficacy findings underscore the importance of vedolizumab as a treatment for appropriate patients with moderate to severely active ulcerative colitis, both as first-line biologic therapy in both patients who have never received TNF antagonist treatment or who have failed these agents.”
Vedolizumab is a humanized monoclonal antibody that is designed to antagonize the alpha4beat7 integrin, inhibiting the binding of alpha4beta7 to intestinal mucosal address in cell adhesion molecule 1 (MAdCAM-1) and fibronectin, but not vascular cell adhesion molecule 1 (VCAM-1). It is marketed as Entyvio for the treatment of UC and Crohn’s Disease and was approved in the U.S. in 2014.
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