Vedolizumab success in GEMINI 1 trial for Ulcerative Colitis

Results from the Gemini trials of MLN 0002 (vedolizumab), from Takeda, were published in the NEJM and GEMINI I, a placebo-controlled induction and maintenance study in patients with Ulcerative Colitis, showed that vedolizumab met primary endpoints of improvement in clinical response (reduction in the Mayo Clinic score of at least 3 points and at least 30% from baseline, along with a decrease of at least 1 point on the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1) at six weeks and clinical remission (Mayo score of 2 or lower and no subscore higher than 1) at 52 weeks.

In addition, a significantly greater proportion of patients receiving vedolizumab achieved mucosal healing (Mayo endoscopic subscore of 0 or 1) at six and 52 weeks, and glucocorticoid-free remission at 52 weeks, compared with placebo. See: "Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis." Feagan B. et al. N Engl J Med. 2013; 369; 8:699-710.