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Some patients with ulcerative colitis fail standard therapies and are intolerant to others. While biologics work well, they are expensive and carry risk for serious adverse effects. In the search for additional UC therapy options, apremilast — an oral small molecule that inhibits inflammation at the level of the mucosa and is FDA approved for psoriasis but not UC — has been tested in a manufacturer-funded, double-blind, phase II trial.
Participants were 170 patients with UC who had failed standard therapies and were biologic-naive. They were randomized to receive 30 mg or 40 mg of apremilast or placebo twice daily for 12 weeks. In a 40-week extension, placebo recipients were randomized to a treatment group, and treatment groups continued the…