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Etrolizumab is a humanized monoclonal antibody that interferes with immune-cell trafficking into the intestine. To assess its efficacy in treating moderate-to-severe ulcerative colitis, researchers conducted an industry-sponsored, multicenter, phase II study. They randomized 124 patients to receive subcutaneous etrolizumab (100 mg) at weeks 0, 4, and 8 and placebo at week 2; a 420-mg loading dose of etrolizumab followed by 300 mg at weeks 2, 4, and 8; or placebo. Results were as follows:
Clinical remission rates were similar between arms at week 6, but at week 10 (the primary endpoint), the remission rate in the 100-mg arm (21%) was higher versus the placebo arm (0%; P<0.01) but similar compared with the 300-mg arm (10%).
Clinical response ra…