Vedolizumab: Phase III data
Top-line data from the double-blind, international Phase III GEMINI I trial in 895 patients showed that IV vedolizumab met the co-primary endpoints of a greater proportion of patients with a clinical response at week 6 (induction phase) and a greater proportion of patients in clinical remission at week 52 (maintenance phase) vs. placebo. The most common adverse events were colitis, headache and nasopharyngitis. The trial enrolled patients with moderately to severely active UC who have failed >=1 conventional therapy, including tumor necrosis factor (TNF) alpha antagonists, to receive vedolizumab or placebo at weeks 0, 2 and 6 in the initial induction stage of the trial, followed by every 4 or 8 weeks for up to 46 weeks during the maintenance stage. Patients have an option to continue treatment for up to 2 years in the open-label Phase III GEMINI LTS extension study. ...