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Extended report
Effect of certolizumab pegol over 96 weeks in patients with psoriatic arthritis with and without prior antitumour necrosis factor exposure
  1. P Mease1,
  2. A Deodhar2,
  3. R Fleischmann3,
  4. J Wollenhaupt4,
  5. D Gladman5,
  6. P Leszczyński6,7,
  7. P Vitek8,
  8. A Turkiewicz9,
  9. M Khraishi10,
  10. O FitzGerald11,
  11. R Landewé12,
  12. M de Longueville13,
  13. B Hoepken14,
  14. L Peterson15 and
  15. D van der Heijde16
  1. 1Swedish Medical Center and University of Washington, Seattle, Washington, USA
  2. 2Oregon Health & Science University, Portland, Oregon, USA
  3. 3University of Texas SW Medical Center, Dallas, Texas, USA
  4. 4Schoen Klinik, Hamburg, Germany
  5. 5Toronto Western Research Institute, Toronto, Canada
  6. 6Poznan Medical University, Poznan, Poland
  7. 7Division of Rheumatology and Osteoporosis, Jozef Strus Hospital, Poznan, Poland
  8. 8PV-MEDICAL, Revmavita Centre, Zlin, Czech Republic
  9. 9Rheumatology Associates Clinical Research Unit, Birmingham, Alabama, USA
  10. 10Department of Medicine, Memorial University of Newfoundland, St. John's, Canada
  11. 11Department of Rheumatology, St. Vincent's University Hospital and Conway Institute for Biomolecular Research, University College, Dublin, Ireland
  12. 12Academic Medical Center, Amsterdam and Atrium Medical Center, Heerlen, The Netherlands
  13. 13UCB Pharma, Brussels, Belgium
  14. 14UCB Pharma, Monheim, Germany
  15. 15UCB Pharma, Raleigh, North Carolina, USA
  16. 16Leiden University Medical Centre, Leiden, The Netherlands
  1. Correspondence to Professor Philip J Mease; pmease{at}philipmease.com

Abstract

Objective Previous reports of RAPID-PsA (NCT01087788) demonstrated efficacy and safety of certolizumab pegol (CZP) over 24 weeks in patients with psoriatic arthritis (PsA), including patients with prior antitumour necrosis factor (TNF) therapy. We report efficacy and safety data from a 96-week data cut of RAPID-PsA.

Methods RAPID-PsA was placebo-controlled to week 24, dose-blind to week 48 and open-label to week 216. We present efficacy data including American College of Rheumatology (ACR)/Psoriasis Area and Severity Index (PASI) responses, HAQ-DI, pain, minimal disease activity (MDA), modified total Sharp score (mTSS) and ACR responses in patients with/without prior anti-TNF exposure, in addition to safety data.

Results Of 409 patients randomised, 273 received CZP from week 0. 54 (19.8%) CZP patients had prior anti-TNF exposure. Of patients randomised to CZP, 91% completed week 24, 87% week 48 and 80% week 96. ACR responses were maintained to week 96: 60% of patients achieved ACR20 at week 24, and 64% at week 96. Improvements were observed with both CZP dose regimens. ACR20 responses were similar in patients with (week 24: 59%; week 96: 63%) and without (week 24: 60%; week 96: 64%) prior anti-TNF exposure. Placebo patients switching to CZP displayed rapid clinical improvements, maintained to week 96. In patients with ≥3% baseline skin involvement (60.8% week 0 CZP patients), PASI responses were maintained to week 96. No progression of structural damage was observed over the 96-week period. In the Safety Set (n=393), adverse events occurred in 345 patients (87.8%) and serious adverse events in 67 (17.0%), including 6 fatal events.

Conclusions CZP efficacy was maintained to week 96 with both dose regimens and in patients with/without prior anti-TNF exposure. The safety profile was in line with that previously reported from RAPID-PsA, with no new safety signals observed with increased exposure.

Trial registration number NCT01087788.

  • Anti-TNF
  • TNF-alpha
  • DMARDs (biologic)
  • Psoriatic Arthritis
  • Spondyloarthritis

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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