Long-Term Health-Related Quality of Life in Patients with Plaque Psoriasis Treated with Certolizumab Pegol: Three-Year Results from Two Randomised Phase 3 Studies (CIMPASI-1 and CIMPASI-2).

Abstract

Certolizumab pegol (CZP) is an Fc-free, PEGylated, anti-tumour necrosis factor biologic. Safety and efficacy data for CZP over 3years have been previously reported. We report 3-year quality of life (QoL) outcomes for patients treated with CZP, pooled from two phase 3 trials. Adults with moderate-to-severe plaque psoriasis for ≥ 6months were initially randomised 1:2:2 to double-blinded placebo every 2weeks (Q2W), CZP 200mg Q2W (loading dose of CZP 400mg at weeks0/2/4) or CZP 400mg Q2W. All patients received open-label CZP (200mg or 400mg Q2W) from week48. Dermatology Life Quality Index(DLQI), 36-Item ShortForm Survey (SF-36), EuroQol 5-Dimensions 3-Level(EQ-5D-3L) and Work Productivity and Activity Impairment (WPAI) scores are reported as observed. At week0, 100 patients were randomised to placebo, 186 to CZP 200mg Q2W and 175 to CZP 400mg Q2W. For CZP-randomised patients, 60.9% had a DLQI score of 0 or 1 by week48. Both the physical and mental component scores of SF-36 also improved from baseline to week48 (mean change from baseline: 4.4 and 5.4, respectively). The proportion of patients with a score of 1 in the EQ-5D-3L Pain/Discomfort dimension increased (week0, 21.1%; week48, 66.2%), and WPAI Presenteeism, Work Impairment, and Activity Impairment improved from baseline to week48, with the strongest gains observed for Activity Impairment (week0, 33.3% of time impaired; week48, 6.7%). Across patient-reported outcomes, gains were sustained through week144, with durable improvements observed regardless of sex, psoriatic arthritis status or prior exposure to biologics. CZP treatment was associated with sustained and tangible improvements in health-related QoL (DLQI and SF-36), health status (EQ-5D-3L) and functional impairment at work and in other daily activities (WPAI). ClinicalTrials.gov NCT02326298 (CIMPASI-1) and NCT02326272 (CIMPASI-2).