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Data Published in the New England Journal of Medicine for Vedolizumab, an Investigational New Drug from Takeda for Moderately to Severely Active Ulcerative Colitis and Crohn's Disease
Date:8/21/2013

inical remission at week 52, compared to 8.7 percent of patients receiving placebo (p=0.008, p=0.001, respectively). 31.4 percent and 45.2 percent of patients on oral glucocorticoids at baseline treated with vedolizumab every eight and four weeks, respectively, achieved glucocorticoid-free remission at week 52, compared to 13.9 percent of patients receiving placebo (p=0.01, p<0.001, respectively).

The safety population in GEMINI I comprised 895 patients for weeks 0-52. The most common adverse events reported in the 620-patient vedolizumab arm (greater than or equal to 9.0 percent) were ulcerative colitis, headache, nasopharyngitis and arthralgia. The most common adverse events reported in the 275-patient placebo arm (˃9.0 percent) were ulcerative colitis, headache, nasopharyngitis and arthralgia. No increase in rates of serious, opportunistic or enteric infections was observed with vedolizumab. One death occurred in a 66-yr-old man who received one induction dose of vedolizumab and died 14 days later from acute coronary syndrome.

"Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease"
The publication, titled "Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease," discusses findings from GEMINI II, a Phase 3, randomized, parallel-group, double-blind, placebo-controlled induction and maintenance study designed to assess the efficacy and safety of vedolizumab as a therapy for adults with moderately to severely active Crohn's disease (CD), in whom one prior therapy had failed. In the induction phase, the co-primary endpoints were clinical remission and CDAI-100 response at week six, while the secondary endpoint was mean change in serum C-reactive protein (CRP) levels from baseline to week six. The ITT population comprised 368 patients, with an additional 747 patients receiving open-label vedolizumab. Of the 368, 220 received vedolizumab 300 mg IV and 148 received placebo. Approximately 50 percent of the ITT popula
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SOURCE Takeda Pharmaceutical Company Limited
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