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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

tion had prior anti-TNFalpha failure; 26 percent were primary failures. In addition, approximately 30 percent had failed at least two TNF antagonists. At week six, clinical remission was seen in 14.5 percent of patients randomized to vedolizumab versus 6.8 percent who received placebo (p=0.02). At six weeks, no significant difference was observed in CDAI-100 response between the vedolizumab and placebo groups (31.4 percent versus 25.7 percent, respectively [p=0.23]).  

The maintenance arm of GEMINI II assessed the efficacy and safety of vedolizumab for maintaining response and remission in patients with moderately to severely active CD with evidence of clinical response after two 300 mg IV induction doses of vedolizumab. Patients responding (greater than or equal to 70-point decrease in CDAI from baseline) at week six to induction treatment with vedolizumab were randomized to vedolizumab 300 mg IV every four weeks, every eight weeks, or placebo for up to 52 weeks. The primary endpoint was clinical remission at week 52, while the secondary endpoints were CDAI-100 response, glucocorticoid-free remission at week 52, and durable clinical remission (clinical remission at greater than or equal to 80 percent of visits including the final visit) at week 52. Of the 1,115 patients who received induction treatment, 461 met response criteria at six weeks (ITT population) and were randomized to receive vedolizumab every four weeks (n=154) or eight weeks (n=154), or placebo (n=153). At week 52, remission was seen in 39.0 percent and 36.4 percent of patients randomized, respectively, to vedolizumab every eight weeks or every four weeks versus 21.6 percent of the patients receiving placebo (p<0.001, p=0.004, respectively). CDAI-100 response was seen in 43.5 percent and 45.5 percent of patients randomized, respectively, to vedolizumab every eight weeks or every four weeks versus 30.1 percent of patients receiving placebo at week 52 (p=0.01, p=0.005 respectively). Gluc
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SOURCE Takeda Pharmaceutical Company Limited
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