Entyvio for IBD Shows Promising Safety Results in Long-term Clinical Trial

Entyvio for IBD Shows Promising Safety Results in Long-term Clinical Trial
Takeda Pharmaceuticals recently presented positive five-year results of an eight-year clinical trial (NCT00790933) evaluating the long-term safety of Entyvio (vedolizumab) in patients with active ulcerative colitis and Crohn's disease, two of the most common inflammatory bowel diseases (IBDs). Interim findings of the GEMINI Phase 3 trial, which began in May 2009 and is expected to be complete in July 2017, indicate that patients responding to long-term treatment with Entyvio exhibited clinical response and remission. Patients also improved their health-related quality of life. The data was presented at the 12th Congress of European Crohn's and Colitis Organization (ECCO) Feb. 15-18 in Barcelona, Spain. Entyvio was approved by the U.S. Food and Drug Administration in 2014 for adults with moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). The study enrolled 146 patients with CD and 154 patients with UC who were part of the GEMINI II (NCT00783692) and GEMINI I (NCT00783718) studies. Patients with either Crohn's disease or ulcerative colitis were evaluated for their clinical response to Entyvio treatment. In CD, clinical response was defined as a reduction in the Harvey-Bradshaw Index of at least 3 points from baseline, and for UC, clinical response was a reduction in the partial Mayo score of at least 2 points and more than a 25% change from baseline. Additionally, patients should exhibit a decrease in recta
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