Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease

BACKGROUND The efficacy of vedolizumab, an alpha(4)beta(7) integrin antibody, in Crohn's disease is unknown. METHODS In an integrated study with separate induction and maintenance trials, we assessed intravenous vedolizumab therapy (300 mg) in adults with active Crohn's disease. In the induction trial, 368 patients were randomly assigned to receive vedolizumab or placebo at weeks 0 and 2 (cohort 1), and 747 patients received open-label vedolizumab at weeks 0 and 2 (cohort 2); disease status was assessed at week 6. In the maintenance trial, 461 patients who had had a response to vedolizumab were randomly assign RESULTS At week 6, a total of 14.5% of the patients in cohort 1 who received vedolizumab and 6.8% who received placebo were in clinical remission (i.e., had a score on the Crohn's Disease Activity Index [CDAI] of <= 150, with scores ranging from 0 to approximately 600 and higher scores indicating greater disease activity) (P = 0.02); a total of 31.4% and 25.7% of the patients, respectively, had a CDAI-100 response (>= 100-point decrease in the CDAI score) (P = 0.23). Among patients in cohorts 1 and 2 wh CONCLUSIONS Vedolizumab-treated patients with active Crohn's disease were more likely than patients receiving placebo to have a remission, but not a CDAI-100 response, at week 6; patients with a response to induction therapy who continued to receive vedolizumab (rather than switching to placebo) were more likely to be in remission at week 52. Adverse events were more common with vedolizumab.