Objectives: ACTIVE is assessing the efficacy of apremilast (APR) monotherapy in biologic-naïve subjects with active psoriatic arthritis (PsA) who may have had exposure to one prior conventional disease-modifying anti-rheumatic drug. Work productivity and activity impairment were assessed through week 104.
Methods: Subjects were randomized (1:1) to APR 30 mg b.i.d. or placebo (PBO). Subjects without ≥ 10% improvement in swollen/tender joint counts at week 16 were eligible for early escape. At week 24, all remaining PBO subjects switched to APR. Work productivity and activity impairment were assessed at baseline (BL) and week 16 using the self-administered Work Productivity and Activity Impairment Questionnaire: PsA (WPAI: PsA), which includes four subscale scores (Absenteeism, Presenteeism, Work Productivity Loss, and Activity Impairment; higher scores = greater impairment). Work-related subscales were assessed for employed subjects; activity impairment was assessed for all subjects regardless of job status. Correlations were made at week 16 between WPAI:PsA and 36-item Short FOrm Survey (SF36v2) Physical Functioning (PF), Bodily Pain (Pain), and Vitality (VIT) scores, as well as associations with American College of Rheumatology 20% (ACR20) response. Work productivity was assessed through week 104.
Results: BL parameters were similar for APR and PBO subjects with WPAI:PsA scores. At week 16, APR significantly improved work productivity and activity impairment vs PBO, with significantly greater improvements in overall Work Productivity Loss (p = 0.001) and Activity Impairment (p < 0.001) scores (Table PP36). Estimated change in Absenteeism was similar with APR vs PBO (p = 0.679). Presenteeism showed significant improvement with APR vs PBO (−10.8% vs 4.1%; p = 0.002). At week 16, statistically significant correlations were seen between WPAI:PsA (except Absenteeism) and SF-36v2 PF, Pain, and VIT scores, as were associations with ACR20 response. In subjects randomized to APR at BL, week 16 WPAI:PsA score improvements were generally maintained through week 104 in those continuing APR.
Conclusions: Biologic-naïve subjects receiving APR alone showed an overall improvement in work productivity at week 16, correlating with SF-36v2 PF, Pain, and VIT scores, and associated with the ACR20 response.
