Takeda Pharmaceutical Co. Ltd. (TKPYY.PK) announced top-line results from the international, randomized, placebo-controlled, double-blind GEMINI II pivotal phase 3 trial. The trial evaluated vedolizumab in 1,115 patients with moderately to severely active Crohn's disease who have failed at least one conventional therapy, including TNFa antagonists. Crohn's disease is an inflammatory bowel disease.
The company noted that many of the patients included in the study had failed two or more TNFa antagonists. Patients received a year of vedolizumab (MLN0002) or placebo treatment, starting with six weeks of induction therapy. In both phases of the trial, induction and maintenance, vedolizumab demonstrated statistically significant improvement in the primary endpoint of clinical remission versus placebo. Besides, vedolizumab provided a numerically higher rate of improved response, the other primary end point in the induction phase, although not statistically significant.
According to Takeda Pharma, the most common adverse events reported in both the vedolizumab arm and the placebo arm were Crohn's disease, arthralgia(joint pain), pyrexia(fever), nasopharyngitis(upper respiratory inflammation), headache, nausea, and abdominal pain.
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