Background The RAPID-PsA trial (NCT01087788) has investigated the efficacy and safety of certolizumab pegol (CZP) for the treatment of patients (pts) with psoriatic arthritis (PsA). Previous reports have demonstrated CZP to be safe and efficacious over 96 weeks (wks) of treatment.1
Objectives To report 4-year efficacy and safety data from the RAPID-PsA trial of CZP in PsA pts.
Methods RAPID-PsA was double-blind and placebo-controlled to Wk24, dose-blind to Wk48 and open-label (OL) 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 at Wks 0, 2, 4) continued on their assigned dose in the OL period. Outcomes assessed included: ACR20/50/70 and PASI75/90 responses, minimal disease activity (MDA), HAQ-DI, pain and patient's global assessment of disease activity (PGADA). Efficacy data are presented for all pts originally randomized to CZP. Data are shown as observed case and with imputation: NRI for categorical and LOCF for continuous measures. The safety set consisted of all pts treated with ≥1 dose of CZP to Wk216.
Results 409 pts were randomized, of whom 273 received CZP from Wk0. Of CZP-randomized pts, 91% completed to Wk24, 87% to Wk48 and 67% to Wk216. In the OL period, 17 pts (6.2%) withdrew due to an adverse event (AE) and 5 pts (1.8%) due to loss of efficacy.
ACR responses were sustained in both dose regimens from Wk24 to Wk216 (Table A). In those 166 CZP pts (60.8%) with ≥3% body surface area skin involvement at baseline (BL), PASI75/90/100 responses were maintained to Wk216 (Table A). Improvements in patient-reported outcomes were also maintained through Wk216 (Table B). Pts had further improvements from Wk24 to Wk216 in high-threshold outcomes (ACR70, MDA and PASI100) when either observed case or conservative imputation methods (NRI) were used (Table A).
Pts in the safety set (N=393) had total CZP exposure of 1321 patient-years (PY) with an AE rate (ER) per 100 PY of 258.0. No new safety signals were identified from Wk96 to Wk204, and no additional deaths were reported.
Conclusions CZP efficacy was maintained in PsA pts over 4 years of treatment, with no new safety signals identified. Additional improvements in high-threshold outcomes were seen from Wk24 to Wk216.
Mease P. RMD Open 2015;1:e000119
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.