The findings are important because existing medical therapies for ulcerative colitis and Crohn’s disease have significant limitations, including toxic effects, and new treatment strategies are needed, the investigators said.
The GEMINI 2 investigators noted that patients with moderately to severely active Crohn’s disease, in whom conventional therapy failed, were more likely than those receiving placebo to experience remission at 6 weeks. They were not more likely to have a CDAI-100 response, however.
While the modest effect of treatment on induction of clinical remission, as well as the nonsignificant effect on the CDAI-100, require consideration, and while questions remain about which specific patients with Crohn’s disease may derive the most benefit from vedolizumab and about potential synergistic effects of combining vedolizumab with immunosuppressive agents, the findings nonetheless suggest a role for vedolizumab in Crohn’s disease, they noted.
"In an analysis of patients who had a response to induction therapy with vedolizumab, the rates of clinical remission, CDAI-100 response, and glucocorticoid-free remission at week 52 were higher among patients receiving vedolizumab every 8 weeks or every 4 weeks than among patients who were switched to placebo," they said.
GEMINI 1 and GEMINI 2 were funded by Millennium Pharmaceuticals. The authors disclosed multiple potential conflicts of interest; the details are available with the full text of the articles at NEJM.org.