The trial evaluated vedolizumab in 1,115 Crohn’s disease patients who have failed at least one conventional therapy, including TNFa antagonists.
Takeda General Medicine (Gastrointestinal and Genitourinary) vice president Asit Parikh said, "People living with moderately to severely active Crohn’s disease currently have few treatment options to help them manage their disease."
Vedolizumab demonstrated statistically significant improvement in the primary endpoint of clinical remission compared to placebo, ininduction and maintenance phases of the trial.
Vedolizumab provided a numerically higher rate of enhanced response although not statistically significant.
The common adverse events reported in both the vedolizumab arm and the placebo arm were Crohn’s disease, arthralgia, pyrexia, nasopharyngitis, headache, nausea and abdominal pain.