Apremilast (Celgene) success in Phase III study of Psoriatic Arthritis

Top-line results are reported by Celgene from the PALACE-1 study, the first of three pivotal Phase III, randomized, placebo-controlled studies evaluating apremilast, the novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with Psoriatic Arthritis who had received an oral disease-modifying antirheumatic drug biologic therapy or had failed on an anti-tumor necrosis factor agent. Apremilast treatment in this study was used alone or in combination with an oral DMARD.

In the study, statistical significance for the primary endpoint of ACR20 was achieved for patients receiving apremilast. Patients in the active treatment arms also maintained significant improvements in arthritis-related endpoints, including ACR50 and ACR70 through week 24. Significant and sustained improvements in various measures of physical function were also observed in apremilast-treated patients.The overall safety profile was consistent with previous experiences in the phase II program and tolerability was improved.The PALACE-1 study is ongoing and the study extension remains blinded until all patients complete week 52. Full data from this phase III study will be submitted for presentation at appropriate medical meetings. Top-line results from two pivotal randomized, placebo-controlled phase III studies of apremilast in PsA (PALACE 2 and PALACE 3) are expected in the third quarter of 2012