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Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced results of its long-term phase III study on apremilast, the Company’s first-in-class oral, targeted inhibitor of phosphodiesterase 4 (PDE4), in systemic or biologic DMARD-naïve psoriatic arthritis patients at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego.
PALACE 4 is the first large, randomized, controlled study to examine the efficacy and safety of a novel agent exclusively in systemic or biologic DMARD-naïve psoriatic arthritis patients. Apremilast monotherapy demonstrated clinical benefits over 52 weeks in this treatment-naïve patient population, including clinically meaningful improvements in signs and symptoms of psoriatic arthritis, as well as manifestations of psoriatic arthritis such as physical function (HAQ-DI), skin (PASI-75/50), swollen and tender joints, enthesitis and dactylitis.
At week 16, a statistically significantly greater proportion of patients treated with apremilast monotherapy achieved a modified ACR20 (the study’s primary endpoint) versus placebo: 29.2% (apremilast 20 mg;
P=0.0076) and 32.3% (apremilast 30 mg;
P=0.0011) versus 16.9% (placebo). For those patients randomized to apremilast and completing 52 weeks of the study, an ACR20 response of 53.4% (apremilast 20 mg) and 58.7% (apremilast 30 mg) at week 52 was observed. ACR 50 and 70 was reached by 31.9% and 18.1% of patients, respectively, for apremilast 30 mg.
“In addition to maintaining its long-term safety and tolerability profile consistent with the previously reported data, apremilast monotherapy showed significant clinical benefit in systemic or biologic DMARD-naïve psoriatic arthritis patients,” said Alvin Wells, M.D., Ph.D., Director, Rheumatology and Immunotherapy Center, Franklin, WI, US. “These encouraging results suggest that apremilast may have the potential to be used alone and as a first-line therapy.”
Durable improvements in multiple endpoints—including enthesitis (inflammation at sites where tendons, ligaments or joint capsule fibers insert into bone), dactylitis (swelling of a finger or toe), impaired physical function as assessed by HAQ-DI, swollen and tender joint counts and associated skin psoriasis—were maintained or increased in patients completing 52 weeks of treatment.