Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced results from a long-term (52-week) phase III trial of OTEZLA, the Company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), in psoriatic arthritis patients who have not had prior treatment with systemic or biologic disease-modifying antirheumatic drugs (DMARDs). The data were presented at the European League Against Rheumatism Annual Congress (EULAR 2014) in Paris, France.
“Physicians need a variety of options to treat psoriatic arthritis, as treatment is highly individualized and some patients may not be appropriate candidates for biologics or certain systemic therapies,” said Alvin Wells, M.D., Ph.D., director, Rheumatology and Immunology Center, Franklin, MN. “These efficacy and safety results suggest that OTEZLA monotherapy has the potential to be used for adults with active psoriatic arthritis in the first-line setting, prior to the initiation of DMARD therapy, and possibly as a long-term treatment option.”
PALACE 4: 52-week Enthesitis and Dactylitis
Results demonstrated that treatment with OTEZLA monotherapy in patients with pre-existing enthesitis (inflammation at sites where tendons or ligaments insert into bone) or dactylitis (a count of fingers and toes with inflammation), two key manifestations of psoriatic arthritis, resulted in long-term improvements. Results were sustained over 52 weeks in patients initially randomized to OTEZLA monotherapy and completing 52 weeks of the study. At week 52, median Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) decreased by 75.0 percent and 45.9 percent of patients receiving OTEZLA 30 mg BID achieved a score of 0, indicating no pain at any of the enthesitis sites assessed. OTEZLA 30 mg BID also resulted in a median 100 percent decrease in dactylitis count. A dactylitis count of 0, indicating no signs of dactylitis, was achieved in 68.8 percent of patients.PALACE 4: 52-week Physical Function The results of a physical function analysis from PALACE 4 demonstrated that 52 weeks of treatment with OTEZLA monotherapy resulted in sustained improvements for up to 52 weeks, as measured by validated assessment tools.