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OP0077 Long-Term Safety and Efficacy of Certolizumab Pegol in Patients with Psoriatic Arthritis with and without Prior Anti-Tumor Necrosis Factor Exposure: 96-Week Outcomes from the Rapid-Psa Trial
  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. 2Southwestern Medical Center at Dallas Metroplex Clinical Research Center, Dallas, United States
  3. 3Schoen Klinik, Hamburg, Germany
  4. 4Oregon Health and Science University, Portland, United States
  5. 5Division of Health Care and Outcomes Research, Toronto Western Research Institute, Toronto Western Hospital, Toronto, Canada
  6. 6UCB Pharma, Monheim, Germany
  7. 7UCB Pharma, Raleigh, United States
  8. 8Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands

Abstract

Background Previous reports of RAPID-PsA (NCT01087788) demonstrated efficacy and safety of certolizumab pegol (CZP) over 48 weeks (wks) in psoriatic arthritis (PsA) patients (pts), including pts with prior anti-TNF therapy.1

Objectives To report the clinical efficacy and safety of CZP in PsA from a 96-wk interim data cut of RAPID-PsA.

Methods RAPID-PsA1 is double-blind and placebo (PBO)-controlled to Wk24, dose-blind to Wk48 and open-label to Wk216. Pts had active PsA and had failed ≥1 DMARD. Pts originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose [LD] at Wks 0, 2, 4) continued on their assigned dose in the OLE; PBO pts entering dose-blind phase were re-randomized to CZP LD followed by CZP 200mg Q2W or CZP 400mg Q4W after Wk24 or, for non-responders, Wk16. We present efficacy data for all pts originally randomized to CZP (combined dose regimens). Primary clinical endpoint was ACR20 response at Wk12 [1]. Other endpoints included ACR20/50/70 and PASI75/90 responses, HAQ-DI, pain and minimal disease activity (MDA) [2] at Wk96, and ACR responses in pts with or without prior anti-TNF exposure. Data are shown as observed case and with imputation. NRI was used for categorical measures, LOCF for continuous measures. Safety set consists of all pts treated with ≥1 dose of CZP to Wk96.

Results 409 pts were randomized, of whom 273 received CZP from Wk0. 54 (19.8%) CZP pts had prior anti-TNF exposure with similar baseline (BL) characteristics to pts without. Of CZP-randomized pts, 91% completed Wk24, 87% Wk48 and 80% Wk96. ACR20/50/70 and MDA responses were maintained in both dosing regimens from Wk24 to Wk96 (Table). ACR responses were similar in pts with or without prior anti-TNF exposure (Figure). Pts originally randomized to PBO who switched to CZP at Wk 16 or 24 displayed rapid clinical improvements which were maintained through Wk96. In pts with ≥3% skin involvement at BL (60.8% CZP pts), PASI75 and PASI90 responses were maintained to Wk96 (Table). Improvements in PROs were maintained through Wk96 (Change from BL at Wk24 and Wk96: HAQ-DI: -0.48 vs -0.52; pain: -28.5 vs -31.3). In the safety set (N=393) total exposure to CZP was 606 pt-yrs. Adverse events (AEs) occurred in 345 pts (87.8%; event rate [ER] per 100 pt-yrs=329.8) and serious AEs (SAEs) in 67 (17.0%; ER=14.5). SAEs included malignancies in 4 pts (1.0%; ER=0.7) (including 2 cases of breast cancer, and 1 each of lymphoma and in situ cervix carcinoma) and serious infections in 16 pts (4.1%; ER=3.3). 6 deaths were reported in the overall 96-wk period (1.5%) (2 cardiac disorders, 1 sudden death, 1 infection and 1 case each of breast cancer and lymphoma).

Figure 1.

Maintenance of CZP efficacy in clinical and patient-reported outcomes to Wk96 of the RAPID-PsA trial.

Conclusions The clinical efficacy of CZP was maintained through both the dose-blind and open-label phases of RAPID-PsA. Efficacy was maintained in both dosing regimens and in both TNF-naïve and TNF-experienced pts. The safety profile was in line with that previously reported from the RAPID-PsA trial, with no new safety signals observed with increased exposure.

References

  1. Mease P.J. Arthritis Rheum 2013;65(10):S132-S133;

  2. Coates L. Ann Rheum 2010;69(1):48-53

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: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB Pharma, Vertex, Consultant for: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB Pharma, Vertex, Speakers bureau: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Crescendo, Genentech, Janssen, Lilly, Pfizer, UCB Pharma, R. Fleischmann Grant/research support: Genetech Inc, Roche, Abbott, Amgen, UCB Pharma, Pfizer, BMS, Lilly, Sanofi-Aventis, MSD, Novartis, BiogenIdec, Astellas, AstraZeneca, Janssen, Consultant for: Roche, Abbott, Amgen, UCB Pharma, Pfizer, BMS, Lilly, Sanofi-Aventis, Novartis, Astellas, AstraZeneca, Janssen, J. Wollenhaupt Grant/research support: UCB Pharma, Consultant for: UCB Pharma, A. Deodhar Grant/research support: UCB Pharma, Abbott, Amgen, Janssen, Novartis, Consultant for: UCB Pharma, Abbott, D. Gladman Grant/research support: Abbvie, Amgen, Celgene, Janssen, Pfizer, UCB Pharma, Consultant for: Abbvie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Pfizer, Novartis, UCB Pharma, B. Hoepken Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, D. van der Heijde Consultant for: AbbVie, Amgen, AstraZeneca, Augurex, BMS, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB Pharma, Vertex

DOI 10.1136/annrheumdis-2014-eular.1652

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