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

Authors

  • D. Gladman,

    Corresponding author
    1. Toronto Western Research Institute and Toronto Western Hospital, Toronto, Ontario, Canada
    • Division of Health Care and Outcomes Research, Toronto Western Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada. E-mail: dafna.gladman@utoronto.ca

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    • Dr. Gladman has received consultant fees and/or research grants (less than $10,000 each) from Abbott, Bristol-Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, and UCB Pharma.

  • R. Fleischmann,

    1. Metroplex Clinical Research Center, Dallas, Texas
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    • 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.

  • G. Coteur,

    1. UCB Pharma, Brussels, Belgium
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  • F. Woltering,

    1. UCB Pharma, Monheim, Germany
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    • Dr. Woltering owns stock or stock options in UCB Pharma.

  • P. J. Mease

    1. Swedish Medical Center and University of Washington, Seattle
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    • Dr. Mease has received consultant fees, speaking fees, and/or research grants (less than $10,000 each) from Biogen Idec, Celgene, Crescendo, Genentech, Lilly, Merck, Novartis, and Vertex and (more than $10,000 each) from AbbVie, Amgen, BMS, Janssen, Pfizer, and UCB.


Abstract

Objective

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.

Methods

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.

Results

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.

Conclusion

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.

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