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News Breaks
November 13, 2012
15:35 EDTCELGCelgene reports positive results from PALACE-1 study of psoriatic arthritis
The company previously announced statistical significance for the primary endpoint of ACR20 for patients receiving apremilast in the PALACE-1 study, the first of three pivotal phase III, randomized, placebo-controlled studies evaluating the company's novel, oral small-molecule inhibitor of phosphodiesterase 4 in patients with psoriatic arthritis who had received oral disease-modifying antirheumatic drugs and/or biologic therapy and/or had failed on an anti-tumor necrosis factor agent. Apremilast treatment in this study was used alone or in combination with oral DMARDs. PALACE-1 is the first phase III study demonstrating statistical significance in a psoriatic arthritis patient population that included both prior biologic exposure (23.6%) and biologic failures (9.3%). In the study, apremilast demonstrated statistically significant and higher ACR20 responses at week 16 in patients receiving either apremilast 20 or 30 mg 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-naive subjects receiving apremilast 30 mg BID monotherapy compared with placebo (59% vs. 12%; P<0.005).
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