Dr. Fleischmann has received consultant fees and/or research grants (less than $10,000 each) from Abbott, Amgen, Astellas, AstraZeneca, Biogen Idec, BMS, Genentech, HGS, Janssen, Lexicon, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB Pharma.
Effect of Certolizumab Pegol on Multiple Facets of Psoriatic Arthritis as Reported by Patients: 24-Week Patient-Reported Outcome Results of a Phase III, Multicenter Study†
Version of Record online: 26 JUN 2014
© 2014 The Authors. Arthritis Care & Research is published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
Arthritis Care & Research
Volume 66, Issue 7, pages 1085–1092, July 2014
How to Cite
Gladman, D., Fleischmann, R., Coteur, G., Woltering, F. and Mease, P. J. (2014), Effect of Certolizumab Pegol on Multiple Facets of Psoriatic Arthritis as Reported by Patients: 24-Week Patient-Reported Outcome Results of a Phase III, Multicenter Study. Arthritis Care Res, 66: 1085–1092. doi: 10.1002/acr.22256
ClinicalTrials.gov identifier: NCT01087788.
- Issue online: 26 JUN 2014
- Version of Record online: 26 JUN 2014
- Accepted manuscript online: 10 DEC 2013 02:33PM EST
- Manuscript Accepted: 3 DEC 2013
- Manuscript Received: 12 JUL 2013
- UCB Pharma
To examine the effect of certolizumab pegol (CZP) on patient-reported outcomes (PROs) in psoriatic arthritis (PsA) patients with and without prior tumor necrosis factor (TNF) inhibitor exposure.
The ongoing phase III RAPID-PsA trial was double blind and placebo controlled to week 24. Patients were randomized 1:1:1 to placebo every 2 weeks or CZP 400 mg at weeks 0, 2, and 4, followed by either CZP 200 mg every 2 weeks or CZP 400 mg every 4 weeks. PRO measures evaluated were the Health Assessment Questionnaire (HAQ) disability index (DI), health status (measured by the Short Form 36 [SF-36] health survey), Psoriatic Arthritis Quality of Life (PsAQOL), Fatigue Assessment Scale, patient assessment of pain (visual analog scale), and Dermatology Life Quality Index (DLQI). Post hoc analyses of PROs in patients with and without prior TNF inhibitor exposure were conducted. Change from baseline for all PROs was analyzed for the randomized population using analysis of covariance with last observation carried forward imputation.
A total of 409 patients were randomized. Twenty percent had received a prior TNF inhibitor. Baseline demographics were similar between the treatment groups. At week 24, clinically meaningful differences in HAQ DI, SF-36, PsAQOL, fatigue, pain, and DLQI were observed in both CZP arms versus placebo (P < 0.001), irrespective of prior TNF inhibitor exposure. More CZP-treated patients reached SF-36 general population norms than placebo-treated patients.
Both CZP dosing schedules provided rapid improvements in PROs across multiple disease aspects in patients with PsA. The benefits of CZP treatment for health-related quality of life were seen across generic, PsA-specific, and dermatology-specific measures and were observed in patients regardless of prior TNF inhibitor exposure.