SAT0382 Palace 4, A Phase 3, Randomized, Controlled TRIAL of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, for Treatment of Psoriatic Arthritis: Long-Term (52-WEEK) Improvements in Physical Function

Background Apremilast (APR), an oral phosphodiesterase 4 inhibitor, works intracellularly to regulate inflammatory mediators. PALACE 4 compared APR efficacy/safety with placebo (PBO) in patients (pts) with active PsA who were DMARD-naive. Objectives Evaluate the impact of APR over 52 wks on physical function among PALACE 4 pts. Methods Pts were randomized 1:1:1 to PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30). Pts with Results At Wk 16, a significantly greater proportion of pts treated with APR achieved a modified ACR20 response vs PBO (primary endpoint). Mean changes in HAQ-DI at Wk 16 (key secondary endpoint) were 0.03 (PBO), -0.17 (APR20; P=0.0008), and -0.21 (APR30; P Conclusions Over 52 wks, APR continued to demonstrate clinically meaningful improvements in physical function in active PsA pts who were DMARD-naive. APR demonstrated an acceptable safety profile and was generally well tolerated for up to 52 wks. References Kwok T. J Rheumatol. 2010;37:1024. Mease PJ. J Rheumatol. 2011;38:2461. Revicki DA. Health Qual Life Outcomes. 2008;6:75. Disclosure of Interest A. Wells Grant/research support: Celgene Corporation, C. Edwards Grant/research support: Celgene Corporation, Pfizer Inc, Roche, and Samsung, Consultant for: Celgene Corporation, Pfizer Inc, Roche, and Samsung, Speakers bureau: Abbott, Glaxo-SmithKline, Pfizer Inc, and Roche, A. Adebajo: None declared, A. Kivitz Grant/research support: Amgen, Janssen, Eli Lilly, Novartis, Pfizer Inc, and UCB, Consultant for: Amgen, Janssen, Eli Lilly, Novartis, Pfizer Inc, and UCB, Speakers bureau: Pfizer Inc, P. Bird Grant/research support: Celgene Corporation, K. Shah Employee of: Celgene Corporation, C. Hu Employee of: Celgene Corporation, R. Stevens Employee of: Celgene Corporation, J. Aelion Grant/research support: Ardea, Astra Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor, Galapagos, Genentech, GlaxoSmithKline, Human Genome Sciences, Janssen, Eli Lilly, Merck, Mesoblast, Novartis, Novo Nordisk, Pfizer Inc, Roche, UCB Biosciences, Sanofi-Aventis, Takeda, and Vertex, Consultant for: Ardea, Astra Zeneca, Bristol-Myers Squibb, Celgene Corporation, Centocor, Galapagos, Genentech, GlaxoSmithKline, Human Genome Sciences, Janssen, Eli Lilly, Merck, Mesoblast, Novartis, Novo Nordisk, Pfizer Inc, Roche, UCB Biosciences, Sanofi-Aventis, Takeda, and Vertex, Speakers bureau: AbbVie, Amgen, and UCB DOI 10.1136/annrheumdis-2014-eular.1096