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FRI0472 Improvements in Joint Outcomes of Psoriatic Arthritis over 4 Years of Treatment with Certolizumab Pegol in Patients with and without Prior Anti-TNF Exposure
  1. P.J. Mease1,
  2. R. Fleischmann2,
  3. J. Wollenhaupt3,
  4. A. Deodhar4,
  5. D. Gladman5,
  6. B. Hoepken6,
  7. L. Peterson7,
  8. D. van der Heijde8
  1. 1Swedish Medical Center and University of Washington, Seattle
  2. 2University of Texas SW Medical Center, Dallas, United States
  3. 3Schön Klinik, Hamburg, Germany
  4. 4Oregon Health & Science University, Portland, United States
  5. 5Toronto Western Research Institute, Toronto, Canada
  6. 6UCB Pharma, Monheim, Germany
  7. 7UCB Pharma, Raleigh, United States
  8. 8Leiden University Medical Centre, Leiden, Netherlands

Abstract

Background Previous reports of the RAPID-PsA trial (NCT01087788) have demonstrated the efficacy of certolizumab pegol (CZP) in improving joint outcomes of psoriatic arthritis (PsA) over 96 weeks (wks) of treatment in patients (pts) with and without prior anti-TNF exposure.1,2

Objectives To report the efficacy of CZP over 4 years for the treatment of joint outcomes in PsA pts with and without prior anti-TNF exposure.

Methods The RAPID-PsA trial was double-blind and placebo-controlled to Wk24, dose-blind to Wk48 and open-label (OL) to Wk216. Pts had active PsA, had failed ≥1 DMARD, and ≤40% pts could have received 1 prior anti-TNF. Pts originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks 0, 2, 4) continued on their assigned dose in the OL period. Joint disease activity was assessed in all pts using tender joint count (TJC), swollen joint count (SJC) and DAS28(CRP), as well as the composite disease activity measures ACR20/50/70. Data are shown as observed case (OC) and with imputation: NRI for categorical and LOCF for continuous measures. Data are presented for all pts originally randomized to CZP with and without prior anti-TNF exposure.

Results 409 pts were randomized and 273 received CZP from Wk0 (54/273 pts had prior anti-TNF exposure). Of pts randomized to CZP at baseline, 91% completed to Wk24, 87% to Wk48 and 67% to Wk216.

CZP treatment was associated with improvements in all measures of joint disease activity to Wk24. Improvements in outcomes including TJC, SJC and DAS28(CRP), as well as the composite measures ACR20/50/70, were sustained through to Wk216 of the trial and were similar in pts with and without prior anti-TNF exposure (Figure). Greater improvements were observed in those pts completing to Wk216, as expected (Figure, OC data). Pts experienced further improvements from Wk24 to Wk216 in the high-threshold outcome ACR70 when either OC or NRI was used (Table).

At Wk216, ACR20 responses were similar regardless of dose regimen in pts with and without prior anti-TNF exposure (pts with anti-TNF exposure [OC]: 200mg Q2W: 81.8%; 400mg Q4W: 83.3%; pts without prior anti-TNF exposure [OC]: 200mg Q2W: 75.0%; 400mg Q4W: 85.3%).

Conclusions Improvements in measures of joint disease activity were observed in PsA pts to Wk24 and efficacy was sustained over 4 years. Efficacy remained similar in pts with and without prior anti-TNF exposure in all joint outcomes assessed.

  1. Mease P. RMD Open 2015;1:e000119;

  2. Gladman D. Arthritis Rheum 2015;67(S10)

Acknowledgement The authors acknowledge Costello Medical Consulting, funded by UCB Pharma, for writing and editorial assistance.

Disclosure of Interest P. Mease Grant/research support from: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant for: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Covagen, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Pfizer and UCB Pharma, R. Fleischmann Grant/research support from: Genetech Inc, Roche, Abbott, Amgen, UCB Pharma, Pfizer, BMS, Lilly, Sanofi-Aventis, MSD, Novartis, AstraZeneca and Janssen, Consultant for: Roche, Abbott, Amgen, UCB Pharma, Pfizer, BMS, Lilly, Sanofi-Aventis, Novartis, AstraZeneca and Janssen, J. Wollenhaupt Grant/research support from: UCB Pharma, Consultant for: UCB Pharma, A. Deodhar Grant/research support from: AbbVie, Amgen, Eli Lilly, GSK, Janssen, Novartis, Pfizer and UCB Pharma, Consultant for: AbbVie, Amgen, Boehringer Ingelheim, Janssen, Novartis, Pfizer and UCB Pharma, D. Gladman Grant/research support from: Abbott, Bristol Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, and UCB Pharma, Consultant for: Abbott, Bristol Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, and UCB Pharma, B. Hoepken Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Celgene, Daiichi, Eli-Lilly, Galapagos, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis and UCB Pharma, Employee of: Director of Imaging Rheumatology B.V.

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