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Arthritis Drug Apremilast Appears Safe, Effective in 1-Year Trials

Up to 63% of patients achieve ACR 20 at week 52 (October 28)

Positive results have been reported from long-term (52-week) phase III studies of apremilast (Celgene), a first-in-class, oral, targeted phosphodiesterase 4 (PDE4) inhibitor, in subjects with psoriatic arthritis. The findings included 52-week efficacy results from the PALACE 2 and 3 trials and 52-week pooled safety data from the PALACE 1, 2, and 3 trials.

The study findings were presented Oct. 28 at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting, being held in San Diego, California.

Three pivotal studies (PALACE 1, 2 and 3) were conducted in patients with active psoriatic arthritis who had prior experience with conventional disease-modifying antirheumatic drugs (DMARDs) and/or biologics. The long-term (52 weeks) results from PALACE 1 were reported previously. The long-term results from the two additional pivotal phase III studies (PALACE 2 and PALACE 3) were presented at the ACR/ARHP meeting. Consistent with the results from PALACE 1, significantly more patients treated with apremilast 20 mg or 30 mg twice daily (BID) achieved a modified American College of Rheumatology (ACR) 20 response at week 16 (the primary endpoint) than did those given placebo in both the PALACE 2 trial (placebo, 20%; apremilast 20 mg BID, 38%, P = 0.0002; apremilast 30 mg BID, 34%, P = 0.0024) and the PALACE 3 trial (placebo, 19%; apremilast 20 mg BID, 29%, P < 0.05; apremilast 30 mg BID, 43%, P < 0.0001). Clinically meaningful improvements were also demonstrated in signs and symptoms, physical function, and other manifestations characteristic of psoriatic arthritis, including swollen and tender joints and quality of life.

Sustained improvements in the percentage of patients achieving a modified ACR 20 response at week 52 were observed in both the PALACE 2 trial (apremilast 20 mg BID, 52.9%; apremilast 30 mg BID, 52.6%) and the PALACE 3 trial (apremilast 20 mg BID, 56.0%; apremilast 30 mg BID, 63.0%) in patients randomly assigned to receive apremilast and completing 52 weeks of treatment.

Long-term (52 weeks) safety results from a pooled analysis of the PALACE 1, 2, and 3 trials (including 1,493 patients) identified no new safety findings for patients with psoriatic arthritis who were treated with apremilast for up to 52 weeks, compared with the previously reported 24-week safety results. The most common adverse events were nausea, diarrhea, headache, upper respiratory tract infection, and nasopharyngitis.

Source: Celgene; October 28, 2013.

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