Dermatology and Therapy (Dec 2022)

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)

  • Paolo Gisondi,
  • Alice B. Gottlieb,
  • Boni Elewski,
  • Matthias Augustin,
  • Sandy McBride,
  • Tsen-Fang Tsai,
  • Christine de la Loge,
  • Frederik Fierens,
  • José M. López Pinto,
  • Nicola Tilt,
  • Mark Lebwohl

DOI
https://doi.org/10.1007/s13555-022-00861-4
Journal volume & issue
Vol. 13, no. 1
pp. 315 – 328

Abstract

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Abstract Introduction Certolizumab pegol (CZP) is an Fc-free, PEGylated, anti-tumour necrosis factor biologic. Safety and efficacy data for CZP over 3 years have been previously reported. We report 3-year quality of life (QoL) outcomes for patients treated with CZP, pooled from two phase 3 trials. Methods Adults with moderate-to-severe plaque psoriasis for ≥ 6 months were initially randomised 1:2:2 to double-blinded placebo every 2 weeks (Q2W), CZP 200 mg Q2W (loading dose of CZP 400 mg at weeks 0/2/4) or CZP 400 mg Q2W. All patients received open-label CZP (200 mg or 400 mg Q2W) from week 48. Dermatology Life Quality Index (DLQI), 36-Item Short Form Survey (SF-36), EuroQol 5-Dimensions 3-Level (EQ-5D-3L) and Work Productivity and Activity Impairment (WPAI) scores are reported as observed. Results At week 0, 100 patients were randomised to placebo, 186 to CZP 200 mg Q2W and 175 to CZP 400 mg Q2W. For CZP-randomised patients, 60.9% had a DLQI score of 0 or 1 by week 48. Both the physical and mental component scores of SF-36 also improved from baseline to week 48 (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 (week 0, 21.1%; week 48, 66.2%), and WPAI Presenteeism, Work Impairment, and Activity Impairment improved from baseline to week 48, with the strongest gains observed for Activity Impairment (week 0, 33.3% of time impaired; week 48, 6.7%). Across patient-reported outcomes, gains were sustained through week 144, with durable improvements observed regardless of sex, psoriatic arthritis status or prior exposure to biologics. Conclusion 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). Trial Registration ClinicalTrials.gov NCT02326298 (CIMPASI-1) and NCT02326272 (CIMPASI-2). Video Abstract (MP4 110310 kb)

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