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 limitations on work productivity in patients with chronic health conditions. The PALACE 1, 2, and 3 trials compared the efficacy and safety of APR with placebo 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 over 52 weeks in a pooled analysis.
Methods Patients were randomized (1:1:1) to receive placebo, APR 20 mg BID (APR20), or APR 30 mg BID (APR30). Patients whose swollen and tender joint counts had not improved ≥20% at Week 16 were considered non-responders and were required to be re-randomized (1:1) to APR20 or APR30 if initially randomized to placebo, or continued on their initial APR dose. At Week 24, all patients remaining on placebo were re-randomized to APR20 or APR30. Treatment efficacy at Week 16 was analyzed based on the intent-to-treat population, and analyses at Week 52 and Week 104 were based on data as observed. The WLQ, a 25-item questionnaire that assesses the impact of chronic health conditions on work performance and productivity, was administered at baseline, Week 16, and Week 52. 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 For the 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, MDS, TMS, and ODS, resulting in a greater mean improvement in the WLQ index (Table), which corresponds to a higher mean percent improvement of productivity loss. Productivity improvements in PDS, MDS, TMS, and ODS were also maintained among patients receiving APR20 and APR30 at Week 52 (Table).
Conclusions APR20 and APR30 treatment increased work productivity and improved work limitations among patients with active PsA who were not adequately controlled with prior or concurrent conventional DMARDs and/or prior biologics. Improvements in productivity loss were maintained at Week 52 of treatment.
Disclosure of Interest F. Zhang Employee of: Celgene Corporation, Z. Clancy Employee of: Celgene Corporation, S. Li Employee of: Celgene Corporation