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Pivotal Phase III Data Reported for Apremilast in Psoriatic Arthritis

NDA submission expected in early 2013 (Sept. 6)

Celgene Corporation, based in Switzerland, announced on September 6 that statistical significance for the primary endpoint of ACR20 at week 16 was achieved for patients receiving apremilast 20 mg and 30 mg twice daily in both the PALACE-2 and PALACE-3 phase III trials. Positive PALACE-1 data were previously reported.

PALACE-2 and -3 are the second and third of three pivotal phase III, randomized, placebo-controlled studies evaluating apremilast, the company’s 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 (anti-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.

PALACE-1, -2, and -3 are pivotal phase III multicenter, double-blind, placebo-controlled, parallel-group studies with two active-treatment groups. Approximately 1,500 subjects were randomly assigned to receive either apremilast 20 mg twice daily, 30 mg twice daily, or matching placebo for 24 weeks, with a subsequent extension in which all patients were treated with apremilast. The three PALACE studies included patients with active psoriatic arthritis, including those who had been treated with a DMARD or a biologic DMARD, as well as patients who had previously failed on a TNF blocker. PALACE-3 includes a large subset of patients with significant skin involvement with psoriasis.

The primary endpoint of the three studies was the proportion of patients in each treatment group who achieved the American College of Rheumatology criteria for 20% improvement (ACR20) compared with baseline at week 16. Secondary endpoints included other measures of signs and symptoms, physical function, and patient-reported outcomes.

The PALACE-1, -2, and -3 studies are ongoing, and the study extensions remain blinded to investigational sites until all patients complete week 52. Full data from these phase III trials will be submitted for presentation at appropriate medical meetings.

The NDA submission, based on data from the combined PALACE-1, -2, and -3 trials in patients with psoriatic arthritis, is expected in the first quarter of 2013.

For more information, visit the Celgene Web site.

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