(HealthDay News) – Vedolizumab is associated with improved clinical response and remission vs. placebo for patients with ulcerative colitis or Crohn’s disease, according to two studies published in the Aug. 22 issue of the New England Journal of Medicine.
Brian G. Feagan, MD, from the University of Western Ontario in London, Canada, and colleagues conducted both an induction and a maintenance trial of vedolizumab for patients with active ulcerative colitis. In the induction trial, 374 patients were randomized to vedolizumab or placebo, and 521 patients received open-label vedolizumab, with evaluation at six weeks. In the maintenance therapy trial, patients with a response at six weeks were randomized to receive vedolizumab every eight or four weeks, or placebo. The researchers found that the response rate in the induction trial was significantly better with vedolizumab (47.1% vs. 25.5%) at six weeks. After maintenance therapy, at Week 52, clinical remission was seen for 41.8% and 44.8% of patients receiving vedolizumab every eight and four weeks, respectively, compared to 15.9% for placebo.
William J. Sandborn, MD, from the University of California in San Diego, and colleagues randomly assigned 368 adult patients with active Crohn’s disease to receive vedolizumab or placebo, while 747 patients received open-label vedolizumab. In the maintenance phase, 461 patients who had an initial response to vedolizumab were then randomized to vedolizumab (every eight or four weeks) or placebo. The researchers found that, at week six in the initial phase of the trial, clinical remission was significantly higher in the vedolizumab group vs. the placebo group (14.5% vs. 6.8%). In the maintenance phase, clinical remission at Week 52 was seen in significantly more patients assigned to vedolizumab (39% and 36.4% of patients receiving vedolizumab every eight and four weeks, respectively) vs. placebo (21.6%).
“Vedolizumab-treated patients with active Crohn’s disease were more likely than patients receiving placebo to have a remission,” Sandborn and colleagues write.
Several authors from the Feagan trial disclosed financial ties to pharmaceutical companies, including Millennium Pharmaceuticals, which manufacturers vedolizumab and funded both studies.