Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced results of three long-term (52-week) phase III studies of apremilast, the Company’s first-in-class, oral, targeted inhibitor of phosphodiesterase 4 (PDE4), in psoriatic arthritis at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego. The studies included 52-week efficacy results from PALACE 2 and 3 and 52-week pooled safety data analyses from PALACE 1, 2 and 3, including effects on laboratory measurements.
“Psoriatic arthritis is a debilitating chronic disease requiring long-term treatment,” stated Maurizio Cutolo, M.D., Research Laboratories and Clinical Academic Division of Rheumatology at the University Medical School of Genova, Italy. “The one-year data from the PALACE trials suggest that, with continued treatment, early responses to apremilast are durable over time. Based on the efficacy and safety data to date from phase III studies, apremilast has the potential to offer an additional treatment option for the long-term management of psoriatic arthritis.”
PALACE 2 and PALACE 3: 52-week efficacy data
Three pivotal studies (PALACE 1, 2 and 3) were conducted in patients with active psoriatic arthritis who had prior experience with conventional DMARDs and/or biologics. The long-term (52 weeks) results from PALACE 1 have been previously reported. Today, the long-term results from the two additional pivotal phase III studies (PALACE 2 and PALACE 3) were reported. Consistent with the results from PALACE 1, significantly more patients receiving apremilast 20 mg or 30 mg twice daily (BID) achieved a modified American College of Rheumatology (ACR) 20 response at week 16 (primary endpoint) than did patients taking placebo in both PALACE 2 (placebo, 20%; apremilast 20 mg BID, 38%,
=0.0002; apremilast 30 mg BID, 34%,
=0.0024) and PALACE 3 (placebo, 19%; apremilast 20 mg BID, 29%,
<0.05; apremilast 30 mg BID, 43%,
<0.0001). Clinically meaningful improvements were also demonstrated in signs and symptoms, physical function and other manifestations chartacteristic of psoriatic arthritis, including swollen and tender joints, skin and quality of life.
Sustained improvements in the percentage of patients achieving a modified ACR 20 response at week 52 were observed in both PALACE 2 (apremilast 20 mg BID, 52.9%; apremilast 30 mg BID, 52.6%) and PALACE 3 (apremilast 20 mg BID, 56.0%; apremilast 30 mg BID, 63.0%) for those patients randomized to apremilast and completing 52 weeks of treatment.