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Celgene Corp's Celgene International Sarl Demonstrates Long-Term Clinical Benefits for Patients with Psoriatic Arthritis


Monday, 28 Oct 2013 07:31am EDT 

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation announced results of three long-term (52-week) phase III studies of apremilast, the Company's first-in-class, oral, targeted inhibitor of phosphodiesterase 4 (PDE4), in psoriatic arthritis at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego. The studies included 52-week efficacy results from PALACE 2 and 3 and 52-week pooled safety data analyses from PALACE 1, 2 and 3, including effects on laboratory measurements. Three pivotal studies (PALACE 1, 2 and 3) were conducted in patients with active psoriatic arthritis who had prior experience with conventional DMARDs and/or biologics. Sustained improvements in the percentage of patients achieving a modified ACR 20 response at week 52 were observed in both PALACE 2 (apremilast 20 mg BID, 52.9%; apremilast 30 mg BID, 52.6%) and PALACE 3 (apremilast 20 mg BID, 56.0%; apremilast 30 mg BID, 63.0%) for those patients randomized to apremilast and completing 52 weeks of treatment. The New Drug Application (NDA) and the New Drug Submission (NDS), based on the combined data from PALACE 1, 2 and 3 for psoriatic arthritis, were submitted to health authorities in the U.S. and Canada in Q1 2013 and Q2 2013, respectively. 

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