Mease PJ, Gladman DD, Davenport EK, Zhou X, Guerette B, Teng L, Kaura S, Nash P. Improvements in work productivity with up to 104 weeks of apremilast monotherapy: results from a phase 3b, randomized, controlled study in biologic-naive subjects with active psoriatic arthritis. Poster presented at the 5th World Psoriasis & Psoriatic Arthritis Conference 2018; June 27, 2018. Stockholm, Sweden. [abstract] Acta Derm Venereol. 2018 Jun; 98(Suppl 219):14. Previously presented at the 2017 ACR/ARHP Annual Meeting. doi: 10.2340/00015555-2978

INTRODUCTION: PsA patients may have impaired functioning in home or work activities. The phase 3b ACTIVE study assessed efficacy of apremilast (APR) monotherapy in biologic-naive subjects with active PsA who may have had exposure to 1 conventional DMARD.

OBJECTIVES: Assess work productivity through Wk104.

METHODS: Subjects were randomized (1:1) to APR 30 mg BID or placebo (PBO). Subjects whose SJC/TJC did not improve ≥10% at Wk16 were eligible for early escape. At Wk24, remaining PBO subjects switched to APR. Work productivity and activity impairment were assessed at baseline (BL) and Wk16 using the WPAI:PsA; WPAI:PsA Absenteeism, Presenteeism, Work Productivity Loss, and Activity Impairment subscale scores range from 0% to 100%; higher scores indicate greater impairment. Work-related subscales were assessed in employed subjects; activity impairment was assessed in all subjects. Correlations were examined at Wk16 between WPAI:PsA subscale and SF-36v2 domain scores (Physical Functioning [PF], Bodily Pain [Pain], and Vitality [VIT]) associations with ACR20 response. Work productivity improvement was assessed to Wk104.

RESULTS: BL characteristics were similar between groups. At Wk16, APR improved work productivity and ability to carry out daily activities vs PBO, with greater mean improvements in overall Work Productivity Loss (p = 0.001) and Activity Impairment (p < 0.001). Estimated mean change in Absenteeism score was similar with APR vs PBO (p = 0.679). The Presenteeism score showed significant improvement with APR vs worsening with PBO (−10.8% vs 4.1%; P = 0.002). At Wk16, statistically significant correlations were observed between WPAI:PsA subscale (except Absenteeism) and SF-36v2 domain scores, as were associations with ACR20 response. In subjects randomized to APR at BL, Wk16 improvements were generally maintained to Wk104 in those continuing APR.

CONCLUSIONS: In biologic-naive subjects with PsA, APR contributed to overall improvement in work productivity at Wk16, which correlated with SF-36v2 PF, Pain, and VIT scores and was associated with ACR20 response; improvements in WPAI:PsA subscale scores were generally maintained to Wk104.