Otezla success in ESTEEM 2 trial for Psoriasis - Celgene

Celgene Corporation released new research findings on Otezla (apremilast), the Company's 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 72nd Annual Meeting of the American Academy of Dermatology (AAD) Annual Meeting in Denver, CO.

In ESTEEM 2, a significantly higher percentage of patients receiving Otezla 30 mg BID achieved a PASI-75 response at week 16 (primary endpoint) compared with patients who received placebo (28.8 percent vs. 5.8 percent; p < 0.0001). Statistical significance at week 16 was also demonstrated for the major secondary endpoint, static Physician Global Assessment (sPGA) score of clear or almost clear (p < 0.0001). The beneficial effects of Otezla on psoriasis in difficult-to-treat areas of scalp, nails, palms and soles were also demonstrated in ESTEEM 2. After 16 weeks of treatment, Otezla 30 mg BID demonstrated significantly higher response rates versus placebo for Psoriasis affecting the scalp (ScPGA 0-1: 40.9 percent vs. 17.2 percent; p < 0.0001), nails (NAPSI-50: 44.6 percent vs. 18.7 percent; p < 0.0001), and palm and soles (Palmoplantar Physician Global Assessment (PPPGA) 0-1: 65.4 percent vs. 31.3 percent; nominal p=0.0315).