Celgene International Sàrl, a subsidiary of Celgene Corporation announced that statistical significance for the primary endpoint of ACR20 at week 16 was achieved for patients receiving apremilast 20 mg and 30 mg BID in both the PALACE-2 & 3 phase III studies. Positive PALACE-1 data was previously reported.
PALACE-2 & 3 are the second and third of three pivotal phase III, randomized, placebo-controlled studies evaluating the Company's novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with Psoriatic Arthritis who had received or failed oral disease-modifying antirheumatic drugs (DMARDs), and/or an anti-tumor necrosis factor (TNF) agent. In each of these studies, apremilast was used alone or in combination with oral DMARDs. Patients in the active treatment arms also maintained statistically significant improvements in ACR20 through week 24. Consistent with PALACE-1, statistically significant and clinically meaningful responses in various measures of signs and symptoms and physical function were also observed in both studies in apremilast-treated patients through week 24.