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Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2).

Authors
  • Gordon, K B1
  • Warren, R B2
  • Gottlieb, A B3
  • Blauvelt, A4
  • Thaçi, D5
  • Leonardi, C6
  • Poulin, Y7
  • Boehnlein, M8
  • Brock, F9
  • Ecoffet, C10
  • Reich, K11
  • 1 Department of Dermatology, Medical College of Wisconsin, Milwaukee, WI, USA.
  • 2 Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK.
  • 3 Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • 4 Oregon Medical Research Center, Portland, OR, USA.
  • 5 Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany. , (Germany)
  • 6 Central Dermatology and Saint Louis University School of Medicine, St Louis, MO, USA.
  • 7 Centre de Recherche Dermatologique du Québec Métropolitain, Québec, QC, Canada. , (Canada)
  • 8 UCB Pharma, Monheim, Germany. , (Germany)
  • 9 UCB Pharma, Slough, UK.
  • 10 UCB Pharma, Brussels, Belgium. , (Belgium)
  • 11 Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation® Center, Hamburg, Germany. , (Germany)
Type
Published Article
Journal
British Journal of Dermatology
Publisher
Wiley (Blackwell Publishing)
Publication Date
Apr 01, 2021
Volume
184
Issue
4
Pages
652–662
Identifiers
DOI: 10.1111/bjd.19393
PMID: 32652544
Source
Medline
Language
English
License
Unknown

Abstract

Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumour necrosis factor biologic. To report the 3-year efficacy of CZP in plaque psoriasis, pooled from the CIMPASI-1 (NCT02326298) and CIMPASI-2 (NCT02326272) phase III trials. Adults with moderate-to-severe psoriasis for ≥ 6 months were randomized 2 : 2 : 1 to CZP 200 mg, CZP 400 mg or placebo, every 2 weeks (Q2W) for up to 48 weeks. Patients entering the open-label period (weeks 48-144) from double-blinded CZP initially received CZP 200 mg Q2W. Patients not achieving ≥ 50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 16 entered an open-label CZP 400 mg Q2W escape arm (weeks 16-144). Dose adjustments based on PASI response were permitted during open-label treatment. Outcomes included PASI 75, PASI 90 and Physician's Global Assessment (PGA) 0/1 responder rates, based on a logistic regression model (missing data imputed using Markov Chain Monte Carlo methodology). In total, 186 patients were randomized to CZP 200 mg Q2W and 175 to CZP 400 mg Q2W. At week 48, PASI 75/90 was achieved by 72·7%/51·3% of patients randomized to CZP 200 mg and 84·4%/62·7% randomized to CZP 400 mg. Patients entering the open-label period at week 48, from blinded treatment, received CZP 200 mg Q2W. At week 144, PASI 75/90 was achieved by 70·6%/48·7% patients randomized to CZP 200 mg and 72·9%/42·7% randomized to CZP 400 mg. At week 16, 72 placebo-randomized patients entered the CZP 400 mg Q2W escape arm; 75.7%/58.5% achieved PASI 75/90 at week 144. Both CZP 200 mg and 400 mg Q2W demonstrated sustained, durable efficacy, with numerically higher responses for some outcomes with 400 mg Q2W. © 2020 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

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