Vedolizumab, a humanized monoclonal antibody that inhibits leukocyte trafficking to the gut mucosa, was more effective than placebo in treating patients with moderate to severe active ulcerative colitis and Crohn disease, according to results of 2 separate phase 3 trials involving 2010 patients (Feagan BG et al. N Engl J Med. 2013;369:699-710; Sandborn WJ et al. N Engl J Med. 2013;369:711-721).
Each of the 2 trials, funded by Millennium Pharmaceuticals, had an induction-therapy phase, during which patients were randomly assigned to receive vedolizumab or placebo. Those who had a clinical response at 6 weeks were enrolled in the 52-week maintenance-therapy phase, during which they were randomly assigned to receive vedolizumab every 8 weeks, vedolizumab every 4 weeks, or placebo.