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SAT0298 Effect of Certolizumab Pegol on Signs and Symptoms in Patients with Psoriatic Arthritis from the Rapid-PSA Study: Impact of Baseline Skin Involvement and Prior Anti-TNF Therapy
  1. P. J. Mease1,
  2. R. Fleischmann2,
  3. J. Wollenhaupt3,
  4. A. Deodar4,
  5. D. Kielar5,
  6. F. Woltering6,
  7. C. Stach6,
  8. B. Hoepken6,
  9. T. Arledge7,
  10. D. van der Heijde8
  1. 1Swedish Medical Center and University of Washington, Seattle
  2. 2University of Texas SW Medical Center, Dallas, United States
  3. 3Schoen Klinik, Hamburg, Germany
  4. 4Oregon Health and Science University, Portland, United States
  5. 5UCB Pharma, Brussels, Belgium
  6. 6UCB Pharma, Monheim, Germany
  7. 7UCB Pharma, Raleigh, United States
  8. 8Department of Rheumatology, Leiden University Medical Centre, Leiden, Netherlands

Abstract

Background Certolizumab pegol (CZP), a PEGylated Fc-free anti-TNF, has shown efficacy in reducing signs and symptoms of psoriatic arthritis (PsA) in RAPID-PsA (NCT01087788).1

Objectives To report the efficacy of CZP in PsA patients (pts) with and without prior anti-TNF exposure and to assess the impact of level of baseline skin involvement on PASI response.

Methods The ongoing 158-week (wk) Phase 3 RAPID-PsA trial is double-blind and placebo (PBO)-controlled to Wk24.1 Recruited pts had active PsA, had failed ≥1 DMARD and could have experienced secondary failure to 1 prior anti-TNF. Pts were randomized 1:1:1 to PBO every 2 wks (Q2W), or 400mg CZP at Wk0, 2 and 4 (loading dose) followed by either 200mg CZP Q2W or 400mg CZP every 4 wks (Q4W). Clinical primary endpoint was ACR20 at Wk12. ACR20 was also investigated for pts with and without prior anti-TNF exposure. PASI responses were measured in pts with ≥3% body surface area skin involvement at baseline (BL). Post-hoc analyses of PASI response by BL PASI score (BL PASI <10 vs ≥10) were conducted. NRI was used for ACR and PASI responses. Analyses were performed on the Randomized Set (RS).

Results 409 pts were randomized. BL demographics were similar between groups. 19.1% and 19.8% of PBO and CZP (combined arms) pts received prior anti-TNF. ACR20 at Wk12 was significantly higher in the CZP 200mg Q2W and CZP 400mg Q4W arms vs PBO (58.0% and 51.9% vs 24.3% [p<0.001 for both]) and was observed as early as Wk1.1 At Wk24, PASI75 response in pts with skin involvement (61.6% of RS) was 62.2% with CZP 200mg Q2W and 60.5% with CZP 400mg Q4W vs 15.1% PBO (p<0.001 for both). PASI75 and PASI90 at Wk12 and 24 was higher in pts with PASI ≥10 at BL vs <10 (Figure). ACR20 at Wk24 was similar between CZP 200mg Q2W and CZP 400mg Q4W arms, and greater vs PBO both in pts with (61.3% and 56.5% vs 11.5%) and without (64.5% and 56.3% vs 26.4%) prior anti-TNF exposure. Adverse events (AEs) occurred in 62% vs 68%, and serious AEs in 7% vs 4%, in CZP (combined arms) vs PBO pts, respectively. Two deaths occurred up to Wk24, one sudden death of unknown cause (CZP 400mg Q4W) and one myocardial infarct (CZP 200mg Q2W). No new safety signals were observed.

Conclusions Rapid improvements in the signs and symptoms of PsA and skin manifestations of psoriasis were observed across both CZP dosing regimens. Pts with higher BL PASI were more likely to achieve a PASI75 and PASI90 response. Similar ACR response rates with CZP were observed in pts with and without prior anti-TNF exposure.

References

  1. Mease P. Arthritis Rheum 2012;64(10):1107

Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma.

Disclosure of Interest P. Mease Grant/research support from: Abbott, Amgen, BiogenIdec, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Consultant for: Abbott, Amgen, BiogenIdec, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Speakers bureau: Abbott, Amgen, BiogenIdec, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, R. Fleischmann Grant/research support from: Genetech Inc, Roche, Abbott, Amgen, UCB Pharma, Pfizer, Bristol Myers Squibb, Lilly, Sanofi Aventis, Lexicon, MSD, Novartis, BiogenIdec, Astellas, Astra-Zeneca, Jansen, Consultant for: Roche, Abbott, Amgen, UCB Pharma, Pfizer, BMS, Lilly, Sanofi Aventis, Lexicon, Novartis, Astellas, Astra-Zeneca, Jansen, HGS, J. Wollenhaupt Consultant for: UCB Pharma, A. Deodar Grant/research support from: UCB Pharma, Abbott, Amgen, Janssen, Novartis, Consultant for: UCB Pharma, Abbott, Speakers bureau: Abbott, Novartis, D. Kielar Shareholder of: UCB Pharma, Employee of: UCB Pharma, F. Woltering Shareholder of: UCB Pharma, Employee of: UCB Pharma, C. Stach Shareholder of: UCB Pharma, Employee of: UCB Pharma, B. Hoepken: None Declared, T. Arledge Shareholder of: UCB Pharma, Employee of: UCB Pharma, D. van der Heijde Grant/research support from: AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Daiichi, Eli-Lilly, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, Vertex., Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Daiichi, Eli-Lilly, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, Vertex., Employee of: Imaging Rheumatology bv

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