Celgene International Sàrl, a wholly-owned subsidiary of Celgene, announced results from PALACE 3, the company’s third phase III study in psoriatic arthritis, or PsA, at EULAR, the European Congress of Rheumatology annual meeting in Madrid, Spain. The PALACE 3 study, which evaluated 495 patients, demonstrated statistical significance in achieving the primary endpoint of American College of Rheumatology 20 score at week 16 for patients receiving apremilast compared to placebo. PALACE 3 is the third pivotal phase III, randomized, placebo-controlled study evaluating Celgene’s novel, oral small-molecule inhibitor of phophodiesterase 4 in patients with active psoriatic arthritis who had previously received and/or failed an oral disease-modifying anti-rheumatic drug, or DMARD, and/or biologic therapy. In this study, apremilast treatment was used alone or in combination with oral DMARDs. By design, PALACE 3 includes a subset of 270 patients with significant active psoriatic skin involvement. Patients in the 30 mg BID active treatment arm also demonstrated significant and sustained improvements in psoriasis-related endpoints, including Psoriasis Area Severity Index, or PASI, 50 and PASI-75 at week 24. Similar improvements in 30 mg BID-treated patients were also observed in key secondary endpoints, including various measures of physical function, signs and symptoms and quality of life. The safety and tolerability profile of apremilast in PALACE 3 was consistent with other previously reported phase III studies of the therapy in psoriatic arthritis.
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