INTRODUCTION: Certolizumab pegol (CZP) is an anti-tumor necrosis factor alpha (TNFα) approved for the treatment of moderate to severe plaque psoriasis (PSO). However, data on its real-world use is currently limited. The objective of this study was to describe the 1-year real-world effectiveness of CZP, its impact on health-related quality of life (HRQoL), and safety outcomes in patients with moderate to severe PSO in multi-country settings. METHODS: CIMREAL, a prospective, noninterventional study, was conducted across Europe and Canada from August 2019 to December 2022. Patients were followed for 1-year, receiving CZP 400 mg initial doses at weeks 0, 2, and 4, followed by CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg Q2W maintenance dosing. Effectiveness was assessed using the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Safety was also evaluated. RESULTS: Overall, 399 patients with moderate to severe PSO were included. Of these, 93.7% (374/399) and 77.9% (311/399) completed months 3 and 12, respectively. Mean age (± standard deviation) was 42.9 ± 13.5 years and body mass index was 28.5 ± 6.8 kg/m2, with the majority of patients being female (68.2%). At 12 months, CZP showed substantial effectiveness, achieving PASI 75 and PASI 90 response rates (≥ 75% and ≥ 90% improvement from baseline, respectively) of 77% and 56.5%, respectively. Patients with PASI score of ≤ 3 and ≤ 2 experienced improvement from 3 months (49.8% and 41.1%, respectively) to 12 months (82.0% and 75.3%, respectively). HRQoL considerably improved, with mean DLQI scores decreasing from 12.4 to 2.3 after 12 months of treatment, and the proportion of patients with DLQI 0/1 increased from 28.6% at 3 months to 59.4% at 12 months. The 1-year probability of persistence was approximately 85%. Overall, 30.6% of the patients experienced any adverse events and 9.3% had serious adverse events. CONCLUSION: In routine clinical practice, CZP exhibited consistent effectiveness, positively impacting both skin psoriasis activity and HRQoL. The 1-year persistence of CZP was high, and no new safety signals were identified. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT04053881 https://www. CLINICALTRIALS: gov/study/NCT04053881 .

2nd Department of Dermatology Aristotle University School of Medicine Papageorgiou General Hospital Thessaloniki Greece

Antonio Cardarelli National Hospital Naples Italy

Clinique Sainte Elisabeth Place Louise Godin 15 5000 Namur Belgium

Department of Dermatovenerology University Hospital Motol Prague Czech Republic

Dermatology Centre Northern Care Alliance NHS Foundation Trust Salford Greater Manchester UK

Dermatology Practice Dr Bernhard Korge Oberstraße 75 77 52349 Düren Germany

Division of Dermatology Department of Medicine University of Toronto Toronto Canada

NIHR Manchester Biomedical Research Centre Manchester Academic Health Science Centre Manchester University NHS Foundation Trust Manchester UK

Probity Medical Research Markham ON Canada

The Lynde Institute for Dermatology and Lynderm Research Inc 25 Main Street Markham N Markham ON Canada

UCB Biosciences Monheim am Rhein Germany

UCB Pharma Brussels Belgium

UCB Pharma Madrid Spain

UCB Pharma Morrisville NC USA

University Hospital Igualada Barcelona Spain

University Hospital of Rennes Pontchaillou Rennes France

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ClinicalTrials.gov
NCT04053881