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March 23, 2014
15:44 EDTCELGCelgene releases new research findings on OTEZLA
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. ESTEEM 1 demonstrated a stable mean PASI improvement of 81 to 88% between weeks 32 and 52 for those patients who were treated for 52 weeks with OTEZLA 30 mg BID and who achieved a PASI-75 score at week 32 . These data are consistent with the mean PASI-75 improvement observed between weeks 16 and 32. In the same group of patients, OTEZLA 30 mg BID continued to demonstrate improvements in difficult-to-treat areas affected by plaque psoriasis...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. Statistical significance at week 16 was also demonstrated for the major secondary endpoint, static Physician Global Assessment, sPGA, score of clear or almost clear. 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...“Psoriasis of the nails, scalp and palmoplantar regions is very difficult to treat and can be debilitating for individuals dealing with this chronic disease," said Jennifer Cather, MD, Modern Research Associates, Dallas, Texas. “Results from the 52-week analysis of the ESTEEM program suggest that early responses seen with OTEZLA treatment in multiple efficacy endpoints of plaque psoriasis, including difficult to treat areas, are durable over time. Together with the observed long-term consistent safety and tolerability profile, these findings are encouraging.” A separate analysis of long-term safety and tolerability data from ESTEEM 1 identified no new or unexpected adverse events (AEs) for patients treated with OTEZLA compared with results at week 16...No new or unexpected AEs were identified for patients treated with OTEZLA in ESTEEM 2.
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