Background Previous reports of RAPID-PsA (NCT01087788) have demonstrated the efficacy of certolizumab pegol (CZP) in patients (pts) with psoriatic arthritis (PsA) to Week (Wk) 96 of treatment.1
Objectives Here we report the efficacy of CZP for the treatment of psoriatic skin manifestations in PsA pts over 96 wks, including pts with and without prior anti-TNF exposure and pts with severe skin involvement at baseline (BL).
Methods RAPID-PsA1 was double-blind and placebo-controlled to Wk24, dose-blind to Wk48 and open-label to Wk216. Pts had active PsA, had failed ≥1 DMARD and ≤40% of pts could have received 1 prior anti-TNF. Pts were randomized at BL to either placebo or CZP (200mg Q2W/400mg Q4W, following 400mg loading dose at Wks 0, 2, 4). Primary clinical endpoint was Wk12 ACR20 response.2 Here we present skin data for pts originally randomized to CZP and with BL skin involvement ≥3% body surface area (BSA). Outcomes presented are psoriasis area and severity index (PASI) responses, physician's global assessment of psoriasis (PGA) and dermatology life quality index (DLQI). Data are shown as both observed and imputed values. Non-responder imputation (NRI) was used for categorical outcomes; last observation carried forward (LOCF) for continuous outcomes. Outcomes are presented for pts with or without prior anti-TNF exposure, or for pts with severe BL skin involvement (BL PASI ≥10).
Results 409 pts were randomized and 273 received CZP from Wk0. CZP pts with ≥3% skin involvement at BL (166 pts, 60.8%) had a mean of 24.2% BSA affected by psoriasis and a mean PASI of 12.0 at BL. The primary endpoint of RAPID-PsA was met (ACR20[NRI]: 58.0%, 51.9% vs 24.3%; for CZP 200mg Q2W, 400mg Q4W vs placebo) and ACR responses were maintained to Wk96 (ACR20[NRI]: 60.1% at Wk24 and 64.1% at Wk96, combined CZP doses). Improvements in skin outcomes were observed to Wk96 of CZP treatment (Table A), with similar efficacy seen with both dose regimens (PASI90[NRI]: Wk24: 46.7% and 35.5%; Wk96: 48.9% and 38.2%, for 200mg Q2W and 400mg Q4W, respectively). Efficacy was also maintained in pts with severe skin involvement at BL (PASI ≥10) (PASI90[NRI]: Wk24: 59.5% and 47.1%; Wk96: 45.9% and 47.1%, for 200mg Q2W and 400mg Q4W, respectively). In these pts, greater improvements were observed in PASI responses, as well as the patient-reported measure DLQI, when compared to all pts analyzed (Table A). Similar improvements in skin outcomes were observed in patients with and without prior anti-TNF exposure (Table B).
Conclusions Improvements in skin outcomes, observed in PsA patients treated with CZP to Wk24, were maintained to Wk96 of treatment in patients with and without prior anti-TNF exposure. Patients with severe skin involvement at BL showed greater improvements in skin outcomes. Similar efficacy was observed with both CZP dosing regimen.
Mease P. J. Ann Rheum Dis 2014;73(S2):90.
Mease P. J. Arthritis Rheum 2013;65(10):S132–133
Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma.
Disclosure of Interest M. Khraishi Grant/research support from: Abbott, Amgen and Pfizer, B. Hoepken Employee of: UCB Pharma, O. Davies Shareholder of: UCB Pharma, Employee of: UCB Pharma, T. Arledge Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, P. Mease Grant/research support from: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB Pharma, Consultant for: Abbott) AbbVie, Amgen, BiogenIdec, BMS, Celgene, Covagen, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB Pharma, Speakers bureau: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Pfizer, UCB Pharma.