Vedolizumab Phase III results from GEMINI II study in Crohns Disease

Results from GEMINI II, a placebo-controlled induction and maintenance study in patients with Crohns Disease, showed that MLN 0002 (vedolizumab), from Takeda, demonstrated statistically significant improvement in the primary endpoint of clinical remission (Crohn's disease activity index [CDAI] score less than 150 points) at six weeks and at 52 weeks compared to placebo. At six weeks, no significant difference was observed in the co-primary endpoint of CDAI-100 response (more than a 100-point decrease in the CDAI score) between the vedolizumab and placebo groups. A significantly greater proportion of patients showed CDAI-100 response and glucocorticoid-free remission at 52 weeks.

GEMINI I and GEMINI II are components in the four-part GEMINI Studies, investigating vedolizumab in 2,700 patients in nearly 40 countries, making it the largest Phase III clinical trial program conducted to date simultaneously evaluating both CD and UC.

see- Sandborn W, Feagan B, Rutgeerts P, et al. Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2013;369;8:711-721.