Positive Ph III results with oral Otezla in skin, nail and scalp of patients with plaque psoriasis

US biotech firm Celgene (Nasdaq: CELG) has released positive new research findings on Otezla (apremilast), an oral, selective inhibitor of phosphodiesterase 4 (PDE4), from the ESTEEM 1 and 2 Phase III studies in patients with moderate to severe plaque psoriasis at the Annual Meeting of the American Academy of Dermatology in Denver.

The news follows swiftly on last Friday’s US Food and Drug Administration approval of Otezla for the treatment of adults with active psoriatic arthritis (The Pharma Letter March 24).

In ESTEEM 1 and 2 patients received Otezla 30mg twice daily (BID) or placebo for the first 16 weeks, followed by a maintenance phase through week 32 in which patients on placebo for 16 weeks were switched to Otezla. Patients initially randomized to Otezla 30mg BID and who were PASI 75 (psoriasis area and severity index) responders at week 32 were re-randomized to either Otezla 30mg BID or placebo.