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Original article
4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis
  1. Désirée van der Heijde1,
  2. Atul Deodhar2,
  3. Oliver FitzGerald3,
  4. Roy Fleischmann4,
  5. Dafna Gladman5,
  6. Alice B Gottlieb6,
  7. Bengt Hoepken7,
  8. Lars Bauer7,
  9. Oscar Irvin-Sellers8,
  10. Majed Khraishi9,
  11. Luke Peterson10,
  12. Anthony Turkiewicz11,
  13. Jürgen Wollenhaupt12 and
  14. Philip J Mease13
  1. 1Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
  2. 2Oregon Health and Science University, Portland, Oregon, USA
  3. 3Department of Rheumatology, St Vincent’s University Hospital and Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland
  4. 4Metroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA
  5. 5Centre for Prognosis Studies in the Rheumatic Diseases and Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada
  6. 6Department of Dermatology, New York Medical College, Metropolitan Hospital, New York City, New York, USA
  7. 7UCB Pharma, Monheim, Germany
  8. 8UCB Pharma, Slough, UK
  9. 9Department of Medicine, Memorial University of Newfoundland, St John’s, Canada
  10. 10UCB Pharma, Raleigh, North Carolina, USA
  11. 11Rheumatology Associates Clinical Research Unit, Birmingham, Alabama, USA
  12. 12Schoen Klinik, Hamburg, Germany
  13. 13Swedish Medical Center and University of Washington, Seattle, Washington, USA
  1. Correspondence to Professor Désirée van der Heijde; mail{at}dvanderheijde.nl

Abstract

Objective To report the efficacy, patient-reported, radiographic and safety outcomes of 4 years’ certolizumab pegol (CZP) treatment in patients with psoriatic arthritis (PsA).

Methods RAPID-PsA (NCT01087788) was double-blind and placebo-controlled to Week 24, dose-blind to Week 48 and open-label (OL) to Week 216. Patients were randomised 1:1:1 to either placebo or CZP 200 mg every 2 weeks (Q2W) or 400 mg every 4 weeks (Q4W) (following 400 mg at Weeks 0/2/4). Patients randomised to CZP continued their assigned dose in the OL period. Patients randomised to placebo were re-randomised to CZP 200 mg Q2W or 400 mg Q4W (post-loading dose) at Week 16 (early escape) or after the double-blind phase. We present observed and imputed data; missing values were imputed using non-responder imputation (NRI) for categorical and last observation carried forward (LOCF) for continuous measures.

Results 409 patients were randomised; 20% (54/273) of Week 0 patients randomised to CZP had prior anti-tumour necrosis factor (TNF) exposure; 67% (183/273) completed 216 weeks. By Week 48, 60.4% of patients achieved Disease Activity Index for Psoriatic Arthritis low disease activity or remission, which was maintained; 66.3% achieved these outcomes at Week 216 (NRI). At Weeks 48 and 216, 39.2% of patients achieved minimal disease activity (NRI). 75% reduction in Psoriasis Area and Severity Index responses were 65% and 52% at Weeks 48 and 216 (NRI). Total resolution rates for enthesitis, dactylitis and nail psoriasis, at 4 years, were 71%, 81% and 65%, respectively (LOCF). Structural damage progression was low over 4 years’ treatment. No new safety signals were identified after Week 96.

Conclusions CZP efficacy in treating PsA was maintained over 4 years, in patients both with and without prior anti-TNF exposure, with no new safety signals identified.

  • anti-tnf
  • tnf-alpha
  • dmards (biologic)
  • psoriatic arthritis

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Footnotes

  • Contributors Substantial contributions to study conception/design or acquisition/analysis/interpretation of data; drafting of the publication or revising it critically for important intellectual content and final approval of the publication: all authors.

  • Funding All costs associated with the development of this manuscript were funded by UCB Pharma.

  • Competing interests DvdH has received consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi and UCB Pharma and is the director of Imaging Rheumatology bv. AD has received grants or research support from AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer and UCB Pharma and consulting fees from Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma. OFG has received grants or research support from AbbVie, Bristol-Myers Squibb, Janssen and Pfizer and consulting fees from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Pfizer and UCB Pharma and speaker fees from AbbVie, Celgene Janssen, Novartis, Pfizer and UCB Pharma. RF has received grants or research support from AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, Eli Lilly, Genentech, Janssen, MSD Pharmaceuticals, Novartis, Pfizer, Roche, Sanofi-Aventis and UCB Pharma and consulting fees from AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer and Sanofi-Aventis. DG has received grants or research support and consulting fees from Abbott, Amgen, Bristol-Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer and UCB Pharma. ABG has received consulting fees from Abbott (AbbVie), Aclaris, Actelion, Akros, Allergan, Amgen, Amicus, Astellas, Baxalta, Beiersdorf, Bristol-Myers Squibb, Canfite, Catabasis, Celgene, Centocor (Janssen), Coronado, Crescendo Bioscience, CSL Behring Biotherapies for Life, Dermipsor, Dermira, Eli Lilly, Genentech, GlaxoSmithKline, Incyte, Karyopharm, Kineta One, KPI Therapeutics, Meiji Seika Pharma, Mitsubishi, Novartis, Novo Nordisk, Pfizer, Reddy Labs, Takeda, Tanabe Pharma Development America, TEVA, UCB Pharma, Valeant, Vertex and Xenoport and received grants or research support from Incyte and Janssen. BH, LB, OI-S and LP are employees of UCB Pharma. AT has received grants or research support, consulting fees and speaker fees from Abbvie, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma. JW has received grants or research support and consulting fees from UCB Pharma. PJM has received consulting fees from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Novartis, Pfizer, Sun and UCB Pharma; grants or research support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Sun, UCB Pharma and Zynerba and speaker fees from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Novartis, Pfizer and UCB Pharma.

  • Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.

  • Ethics approval The study protocol, amendments and subject informed consent were reviewed by a national, regional or Independent Ethics Committee (IEC) or Institutional Review Board (IRB) prior to implementation.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Correction notice This article has been corrected since it first published.

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