Celgene announced clinical data from its Phase 2b study of apremilast (CC-10004) in patients with moderate-to-severe plaque-type psoriasis (PSOR-005). This was a double-blind, placebo-controlled, 352-patient, multi-center study in which patients received either 10mg, 20mg or 30mg of apremilast twice per day (BID), or placebo. Forty-one percent of patients treated with 30mg of oral apremilast BID achieved a 75% reduction in the Psoriasis Area and Severity Index (PASI-75) after 16 weeks (p<0.001), compared to 6% of patients receiving placebo. In addition, a dose-dependent effect was observed between the active therapy arms of the study. Specifically, 29% of patients receiving 20mg BID of apremilast achieved a PASI-75 (p<0.001), while 11% of patients receiving 10mg BID of apremilast achieved a PASI-75.
Apremilast is a novel, orally available small molecule compound that exhibits anti-inflammatory activities through the suppression of multiple pro-inflammatory mediators including, TNF-alpha, interleukins 6, 17 & 23, and interferon-gamma among others.
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