Celgene Corporation announced the preliminary results from their Phase 2 study of apremilast for the treatment of adult patients with psoriatic arthritis. This study is a multi-center, randomized, double-blind, placebo-controlled, three-arm study that met its primary objective of assessment of ACR20 at 12 weeks. ACR20 is defined as the percentage of patients achieving a 20% or better improvement according to the American College of Rheumatology (ACR) criteria. ACR20 is the primary assessment utilized by the FDA for assessment of efficacy in psoriatic and rheumatoid arthritis. In the study, both apremilast treatment arms had a significant improvement in their ACR20 outcome versus placebo: 43.5% of patients in the 20 mg twice daily arm and 35.8% of patients in the 40 mg once daily arm achieved an ACR20 compared to 11.8% of patients in the placebo arm.
In addition, the study measured secondary 12-week endpoints including ACR50 and ACR70, defined as the percentage of patients achieving 50% and 70% improvements respectively according to ACR criteria. These measures are utilized to demonstrate clinical benefit for patients in addition to the primary regulatory measure of ACR20. The 12-week ACR50 was 17.4% in the 20mg twice daily arm, 13.4% in the 40 mg once daily arm, and 2.9% in the placebo arm. The 12-week ACR70 was 5.8% in the 20 mg twice daily arm, 7.5% in the 40 mg once daily arm, and 1.5% in the placebo arm.
Apremilast is a novel, orally available small molecule compound that exhibits anti-inflammatory activities through the suppression of multiple pro-inflammatory mediators including, TNF-alpha, interleukins 6, 17 & 23, and interferon-gamma among others.
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