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:10.1007/s13555-022-00861-4

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)

Dermatol Ther (Heidelb). 2023 Jan;13(1):315-328. doi: 10.1007/s13555-022-00861-4. Epub 2022 Dec 13.

Authors

Affiliations

¹ Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy.
² Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
³ Department of Dermatology, University Hospitals of Cleveland, Case Western Reserve University, Cleveland, OH, USA.
⁴ Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
⁵ Royal Free London NHS Foundation Trust, London, UK.
⁶ Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
⁷ PCOM Analytics, Avallon, France.
⁸ UCB Pharma, Brussels, Belgium.
⁹ UCB Pharma, Madrid, Spain.
¹⁰ UCB Pharma, Slough, UK.
¹¹ Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. lebwohl@aol.com.

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).

Keywords: Biologic; Certolizumab pegol; Clinical trial; Patient-reported outcomes; Plaque psoriasis; Quality of life.

Associated data

ClinicalTrials.gov/NCT02326298
ClinicalTrials.gov/NCT02326272