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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

5.5 percent of patients receiving placebo (p<0.001), 16.9 percent achieved clinical remission versus 5.4 percent receiving placebo (p=0.001), and 40.9 percent of vedolizumab-treated patients experienced mucosal healing compared to 24.8 percent of patients receiving placebo (p=0.001).

The maintenance arm of GEMINI I assessed the efficacy and safety of vedolizumab for maintaining clinical response and remission for 52 weeks in patients with moderately to severely active UC with evidence of clinical response and decrease of rectal bleeding after two 300 mg IV induction doses of vedolizumab. The primary endpoint was clinical remission at week 52, while the secondary endpoints were durable clinical response (response at both week six and 52) and durable clinical remission (remission at both week six and 52), mucosal healing at week 52, and glucocorticoid-free remission at week 52 in patients receiving glucocorticoids at week six. Of 895 patients enrolled, 373 met response criteria at six weeks (ITT population) and were randomized to receive vedolizumab 300 mg IV every four weeks (n=125) or eight weeks (n=122), or placebo (n=126) for up to 52 weeks. 41.8 percent and 44.8 percent of patients receiving vedolizumab every eight and four weeks, respectively, were in clinical remission at week 52, compared to 15.9 percent of patients who received placebo (p<0.001). 56.6 percent and 52.0 percent of patients treated with vedolizumab every eight and four weeks, respectively, achieved durable clinical response (defined by a response at both week six and week 52), compared to 23.8 percent of patients receiving placebo (p<0.001). 51.6 percent and 56.0 percent of patients treated with vedolizumab every eight and four weeks, respectively, achieved mucosal healing at week 52, compared to 19.8 percent of patients receiving placebo (p<0.001). 20.5 percent and 24.0 percent of patients treated with vedolizumab every eight and four weeks, respectively, achieved durable cl
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SOURCE Takeda Pharmaceutical Company Limited
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