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Oral Apremilast Demonstrated Clinically Meaningful And Statistically Significant Improvements In Enthesitis And Dactylitis

Stocks in this article: CELG

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced research findings on apremilast, the Company’s first-in-class, oral, targeted inhibitor of phosphodiesterase 4 (PDE4), based on pooled data analyses from three randomized, controlled, phase III trials in psoriatic arthritis—PALACE 1, 2 and 3—at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego.

Pre-specified analyses from PALACE 1, 2 and 3 pooled data demonstrated that treatment with apremilast in patients with pre-existing enthesitis or dactylitis, two key manifestations of psoriatic disease, resulted in statistically significant and clinically meaningful improvements in enthesitis and dactylitis scores. At week 24, mean change from baseline in the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) reached statistical significance for apremilast 30 mg twice daily (BID; -1.4 vs. -0.8 for placebo; p=0.0159), but not for apremilast 20 mg BID (-1.2; P=NS). At week 24, mean changes from baseline in dactylitis count (a count of fingers and toes with dactylitis) were -1.5 ( P=NS) for apremilast 20 mg BID and -1.8 ( P=0.0121) for apremilast 30 mg BID, versus -1.2 for placebo.

For those patients randomized to apremilast and completing 52 weeks of the study, the median percent change from baseline in MASES and dactylitis count were -66.7% and -100% for both apremilast treatment arms, respectively.

“Psoriatic arthritis is a serious, painful arthritic condition with signs and symptoms that can make day-to-day activities difficult and impede quality of life for many patients,” said Dafna Gladman, M.D., FRCPC, Professor of Medicine, University of Toronto. “Data from these pooled phase III trials showed that apremilast treatment significantly controlled multiple manifestations of psoriatic arthritis and suggest apremilast may provide patients who are living with painful, persistent signs and symptoms of the disease with a new long-term treatment option.”

Patients treated with apremilast achieved significant reduction in number of swollen and tender joints after 16 weeks, which was maintained over 52 weeks.

A characteristic of psoriatic arthritis is tenderness and swelling in and around the joints and places where tendons and ligaments connect to bone, which can be potentially disabling if untreated. Results from all three of the PALACE studies (PALACE 1, 2 and 3) demonstrated that the number of swollen joints and the number of tender joints were both significantly reduced in patients with psoriatic arthritis who were treated with apremilast for 16 weeks compared with placebo.

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