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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

ocorticoid-free remission was seen in 31.7 percent and 28.8 percent of patients taking oral glucocorticoids at baseline randomized, respectively, to vedolizumab every eight weeks or every four weeks versus 15.9 percent of patients receiving placebo at week 52 (p=0.02, p=0.04, respectively).

The safety population in GEMINI II comprised 1,115 patients for weeks 0-52. The most common adverse events reported in the 814-patient vedolizumab arm (˃8.0 percent) were Crohn's disease exacerbation, arthralgia, pyrexia, nasopharyngitis, headache, nausea and abdominal pain. The most common adverse events reported in the 301-patient placebo arm (greater than or equal to 8.0 percent) were Crohn's disease exacerbation, headache, arthralgia, pyrexia, abdominal pain, nausea, and nasopharyngitis. Five deaths occurred during the study period, four among patients receiving vedolizumab (one death each from Crohn's disease with sepsis, intentional overdose of prescription medication, myocarditis, and septic shock) and one in the placebo group (from bronchopneumonia).

About the GEMINI™ Studies          
Announced in early 2009, the GEMINI Studies™ is a Phase 3 program evaluating the effect of vedolizumab on clinical response and remission (along with effect on mucosal healing in UC), and long-term safety in moderately to severely active CD and UC patients who had failed at least one conventional therapy or a TNFalpha antagonist. The GEMINI program consists of four separate studies – a placebo-controlled induction and maintenance study in patients with UC (GEMINI I), a placebo-controlled induction and maintenance study in patients with CD (GEMINI II), a placebo-controlled induction study in patients with CD (GEMINI III) and an open-label long-term safety study in patients with either CD or UC (GEMINI LTS).

About Crohn's disease and ulcerative colitis
Crohn's disease (CD) and ul
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SOURCE Takeda Pharmaceutical Company Limited
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