Apremilast Meets Endpoints in Pivotal Psoriasis Trials
Celgene announced results from the ESTEEM 1 & 2 pivotal Phase 3 studies, evaluating apremilast in patients with moderate to severe chronic plaque psoriasis. Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4).
ESTEEM 1 & 2 were two randomized, placebo-controlled study evaluating apremilast in subjects with a diagnosis of moderate to severe chronic plaque psoriasis for at least 12 months prior to the screening, and at baseline, and who are also a candidate for phototherapy and/or systemic therapy. Approximately 1,250 patients were randomized 2:1 to receive either apremilast 30mg BID or placebo for the first 16 weeks, followed by a maintenance phase from Weeks 16–32 in which placebo subjects were switched to apremilast 30mg BID through Week 32, and a randomized withdrawal phase for responders from Week 32–Week 52 based on their initial randomization and PASI response.
Statistical significance was achieved for the primary endpoint of PASI 75 at Week 16. Patients on apremilast also achieved a statistically significant benefit over placebo in the major secondary endpoint, Static Physician Global Assessment.
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