IMPACT OF APREMILAST ON PHYSICAL FUNCTION OVER 52 WEEKS IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
Author(s)
Mughal F1, Tencer T2, Clancy Z2, Zhang F2
1Celgene Corporation, Uxbridge, UK, 2Celgene Corporation, Warren, NJ, USA
Presentation Documents
OBJECTIVES The PALACE studies compared the efficacy and safety of apremilast (APR) with placebo in patients with active psoriatic arthritis (PsA) despite prior conventional disease-modifying antirheumatic drugs and/or biologics. The objective was to assess the impact of APR on physical functioning in patients enrolled in the PALACE trials. METHODS The pooled analysis included data from PALACE 1-3, three 52-week, randomized, placebo-controlled studies evaluating APR in subjects with active PsA. Patients were randomized (1:1:1) to placebo, APR 20 mg BID (APR20), or APR 30 mg BID (APR30). Patients with <20% reduction from baseline in swollen and tender joint counts at Week 16 were required to be re-randomized (1:1) to APR20 or APR30 if initially randomized to placebo, or continued their initial APR dose. At Week 24, all remaining placebo patients were re-randomized to APR20 or APR30. The analysis reports data from the APR-exposure period (Weeks 0 to 52). Physical function, a pre-specified secondary end point, was measured using the Health Assessment Questionnaire-Disability Index (HAQ-DI) and the 36-item Short-Form Health Survey version 2 Physical Functioning (PF) domain and physical component summary (PCS) scores. RESULTS At Week 16, the observed physical function change from baseline was improved with APR20 and APR30 vs. placebo, as measured by the HAQ-DI (-0.17 [P<0.001] and -0.23 [P<0.001] vs. -0.07), PF (2.73 [P<0.007] and 4.08 [P<0.001] vs. 1.52), and PCS (3.44 [P<0.002] and 4.46 [P<0.001] vs. 2.03). At Week 52, among patients who were treated with APR continuously, the physical function change from baseline for APR20 and APR30 was improved, as measured by the HAQ-DI (-0.30 and -0.33), PF (5.55 and 5.53), and PCS (6.37 and 6.23). CONCLUSIONS Patients treated with APR30 reported improvement in physical function compared with placebo, as measured by the HAQ-DI, PF, and PCS. This response was maintained over 52 weeks.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PMS1
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Musculoskeletal Disorders