Apremilast is an oral small-molecule inhibitor of phosphodiesterase-4 which modulates a wide array of pro- and anti-inflammatory mediators in UC. Application showed clinically meaningful improvement in symptoms, endoscopy, biomarkers, and mucosal healing compared with placebo.
A phase-2 study enrolled 170 patients who failed at least one conventional UC therapy and who were naïve to biologic therapy. These patients had active UC, defined as a total Mayo score (TMS) of 6 to 11, with a Mayo endoscopic score (MES) ≥2). They were randomised 1:1:1 to receive apremilast 30 mg twice daily (BID; n=57), apremilast 40 mg BID (n=55), or placebo (n=58) for up to 12 weeks. Mean baseline TMS and MES were 8.3 and 2.6, respectively.
At week 12, significantly more patients treated with apremilast 30 mg than placebo achieved TMS clinical remission as well as modified Mayo score clinical remission. A higher proportion of patients treated with apremilast 30 mg and ap...
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