Celgene announced top-line results from the PALACE-1 study, the first of three pivotal Phase 3, randomized, placebo-controlled studies evaluating apremilast in patients with psoriatic arthritis who had received an oral disease-modifying antirheumatic drug (DMARD), biologic therapy or had failed on an anti-tumor necrosis factor (TNF) agent. Apremilast treatment in this study was used alone or in combination with an oral DMARD.
PALACE-1 is one of three pivotal Phase 3 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 twice daily, 30 mg twice daily, or identically-appearing placebo for 24 weeks, with a subsequent extension in which all patients are treated with apremilast.
The primary endpoint of the study is the proportion of patients in each treatment group who achieved the American College of Rheumatology criteria for 20% improvement (ACR20) compared to baseline at Week 16. Secondary endpoints include other measures of signs and symptoms, physical function and patient-reported outcomes.
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 PALACE-1 study is ongoing and the study extension remains blinded until all patients complete Week 52.
Apremilast, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, and other inflammatory cytokines. Elevation of cAMP also increases anti-inflammatory cytokines such as IL-10.
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