Background Apremilast (APR), an oral phosphodiesterase 4 inhibitor, works intracellularly to regulate inflammatory mediators. The Work Limitations Questionnaire (WLQ) is a reliable tool for assessing work productivity in patients with chronic health conditions. PALACE 1 compared the efficacy and safety of APR with placebo (PBO) in patients with active psoriatic arthritis (PsA) despite prior conventional disease-modifying antirheumatic drugs (DMARDs) and/or biologics.
Objectives Assess the effect of APR on work productivity and work limitations in the PALACE 1 study.
Methods Patients were randomized 1:1:1 to PBO, APR 20 mg BID (APR20), or APR 30 mg BID (APR30) stratified by baseline DMARD use (yes/no), and treated for 16 weeks to reach the primary end point. Patients completed the WLQ, a 25-item questionnaire that assesses the impact of chronic health conditions on work performance and productivity, at baseline and Week 16. Work limitations were categorized into 4 domains: physical demands (PDS), mental demands (MDS), time management demands (TMS), and output demands (ODS), which were then used to calculate the WLQ index.
Results 504 patients were randomized in PALACE 1. Of the 261 patients who completed the WLQ, baseline work productivity and work limitations were similar across treatment groups. At Week 16, APR20 and APR30, vs. placebo, were associated with a greater mean change from baseline in PDS (-5.58 and -6.24 vs. -2.14), MDS (-2.22 and
-5.18 vs. 1.15), TMS (-4.03 and -8.76 vs. -4.25), and ODS (-5.92 and -10.3 vs. -1.34), resulting in a greater mean improvement in the WLQ index (-0.01 and -0.03 vs. 0.00), which corresponds to a higher median percent improvement of productivity loss (18.9% and 24.7% vs. -3.7%). Higher productivity improvements were also observed among APR20 and APR30 ACR20 responders at Week 16 – PDS (-11.8 and -7.61), MDS
(-8.56 and -11.0), TMS (-7.88 and -15.8), and ODS (-10.6 and -20.1) – resulting in a higher mean improvement in the WLQ index (-0.03 and -0.05), which corresponds to a higher median percent improvement in work productivity (57.9% and 46.8%).
Conclusions APR20 and APR30 increased work productivity and improved work limitations compared with PBO in patients with active PsA despite prior conventional disease-modifying antirheumatic drugs (DMARDs) and/or biologics.
Disclosure of Interest F. Zhang Employee of: Celgene Corporation, T. Tencer Employee of: Celgene Corporation, S. Li Employee of: Celgene Corporation