PMS4 - Impact Of Apremilast On Physical Function In Patients With Psoriatic Arthritis

Abstract

The PALACE 1 study compared the efficacy and safety of apremilast (APR) with placebo in patients with active psoriatic arthritis despite prior conventional disease-modifying antirheumatic drugs (DMARDs) and/or biologics. The objective of the study was to assess the impact of APR therapy on physical functioning in patients enrolled in the PALACE 1 study. Patients were randomized 1:1:1 to placebo, APR 20 mg BID (APR20), or APR 30 mg BID (APR30) stratified by baseline DMARD use (yes/no). Treatment efficacy was assessed at Week 16 based on the full analysis set population. Physical function, a pre-specified secondary end point, was measured in patients using the 36-item Short-Form Health Survey version 2 (SF-36v2) Physical Function (PF) domain, SF-36v2 physical component summary (PCS), and Health Assessment Questionnaire-Disability Index (HAQ-DI) scores. 504 patients were randomized (49.4%: male; mean age: 50.4 years). At Week 16, the physical function change from baseline was significantly improved with APR30 vs. placebo, as measured by the SF-36v2 PF (4.23 vs. 1.81; P=0.006), SF-36v2 PCS (4.59 vs. 2.39; P=0.0097), and HAQ-DI (-0.244 vs. -0.086; P=0.0017) scores. APR20 was associated with a significant improvement in the HAQ-DI score (-0.198 vs. -0.086; P=0.025), but not in the SF-36v2 PF (3.5 vs. 1.81; P=0.050) and SF-36v2 PCS (3.53 vs. 2.39; P=0.175) scores at Week 16. While both APR30 and APR20 showed a benefit in disability over 16 weeks, APR30 is consistently effective as measured by the improvement compared with placebo in the SF-36v2 PF, SF-36v2 PCS, and HAQ-DI scores in patients with active psoriatic arthritis.