Loading...
Vedolizumab, an anti-integrin antibody, is FDA-approved to treat ulcerative colitis (UC) and Crohn disease. Abrilumab, a similar anti-integrin, was tested in 354 patients with moderate-to-severe UC randomized to placebo or subcutaneous abrilumab (7, 21, or 70 mg) on day 1, weeks 2 and 4, and every 4 weeks, or a single dose of 210 mg on day 1. The primary endpoint in the industry-supported trial was remission at 8 weeks for the two higher doses versus placebo. There was a threefold increased likelihood of remission in the 70-mg and 210-mg dosing arms versus the placebo group (odds ratios, 3.4 and 3.3, respectively; P<0.05 for both). There was no greater number of adverse events in any treatment arm versus placebo.