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
Authors: P.J. Mease, R. Fleischmann, J. Wollenhaupt, A. Deodhar, D. Gladman, B. Hoepken, L. Peterson, D. van der Heijde
Journal: Annals of the Rheumatic Diseases (2014)

<h3>Background</h3> 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.<sup>1</sup> <h3>Objectives</h3> To report the clinical efficacy and safety of CZP in PsA from a 96-wk interim data cut of RAPID-PsA. <h3>Methods</h3> RAPID-PsA<sup>1</sup> 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. <h3>Results</h3> 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 <i>in situ</i> 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). <h3>Conclusions</h3> 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. <h3>References</h3> Mease P.J. Arthritis Rheum 2013;65(10):S132-S133; Coates L. Ann Rheum 2010;69(1):48-53 <h3>Acknowledgements</h3> The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma. <h3>Disclosure of Interest</h3> 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 <h3>DOI</h3> 10.1136/annrheumdis-2014-eular.1652