Celgene announced results from PALACE-1, the Company’s first Phase 3 study of apremilast in psoriatic arthritis. Apremilast, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators.
PALACE-1 was one of three pivotal multi-center, double-blind, placebo-controlled, parallel-group studies with 2 active-treatment groups. Approximately 500 subjects were randomized 1:1:1 to receive either apremilast 20mg BID, 30 mg BID, or identically-appearing placebo for 24 weeks, with a subsequent extension in which all patients were treated with apremilast. Patients had psoriatic arthritis and had received oral disease-modifying antirheumatic drugs (DMARD) and/or biologic therapy and/or had failed on an anti-tumor necrosis factor (TNF) agent. Apremilast treatment in this study was used alone or in combination with oral DMARDs.
Apremilast demonstrated statistically significant and higher American College of Rheumatology criteria for 20% improvement (ACR20) responses at Week 16 in patients receiving either apremilast 20mg or 30mg BID monotherapy (31.5% and 50.8% respectively vs. 10.5% for placebo; P<0.05 and P≤0.0001), with no meaningful advantage to adding oral DMARDs to apremilast. A higher ACR20 response at Week 16 was also demonstrated in biologic-naïve subjects receiving apremilast 30mg BID monotherapy compared with placebo (59% vs. 12%; P<0.005).
Across the entire study population, statistically significant changes in reducing signs and symptoms of psoriatic arthritis, as measured by the primary endpoint of ACR20 at Week 16, were achieved for patients receiving apremilast 30mg BID vs. placebo (41.01% vs. 19.4%; P≤0.0001).
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