Clinically meaningful improvements in enthesitis, dactylitis and physical function with OTEZLA seen at week 16 and were sustained for up to 52 weeks of treatment
PALACE 4 is the first and only large randomized, placebo-controlled study to examine the efficacy and safety of a single agent in patients na?ve to previous DMARD therapy
Long-term safety and tolerability profile with OTEZLA consistent with previous PALACE studies
BOUDRY, Switzerland--(BUSINESS WIRE)-- 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."