Effect of certolizumab pegol over 48 weeks on signs and symptoms in patients with psoriatic arthritis with and without prior tumor necrosis factor inhibitor exposure

Background: Previous reports of RAPID-PsA demonstrated efficacy and safety of certolizumab pegol (CZP), a PEGylated Fc-free anti-TNF, over 24 weeks in PsA patients, including patients with prior anti-TNF therapy. We report efficacy and safety of CZP in PsA patients to Wk48. Methods: The RAPID-PsA trial (NCT01087788) is double-blind, placebo (PBO)-controlled to Wk24 and dose-blind to Wk48. Patients had active PsA and had failed ≥1 DMARD. Patients randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks 0, 2, 4) continued their assigned dose in dose-blind phase; PBOpatients entering dose-blind phase were re-randomized to loading dose followed by CZP 200mg Q2W or 400mg Q4W. We report efficacy for patients originally randomized to CZP. Primary endpoints were Wk12 ACR20 response and Wk24 change from baseline (CFB) in modified Total Sharp Score (mTSS). Other endpoints included PASI75/ 90 and ACR20/50/70 response, CFB in HAQ-DI, PsAQoL, pain (VAS) and fatigue (NRS) at Wks24 and 48, and mTSS at Wk48. Post-hoc analyses evaluated minimal disease activity (MDA; Wks 24 and 48), and compared ACR response±prior anti-TNF exposure. Safety set includes all patients receiving CZP. Results: Of 273 patients randomized to CZP, 91% completed to Wk24 and 87% to Wk48. 54/273 (19.8%) had prior anti-TNF exposure. ACR20/50/70 and MDA response rates were maintained from Wk24 to Wk48 (Table 1), and were similar in patients with/without prior anti- TNFs (Wk48 ACR20: prior anti-TNF vs no prior anti-TNF=61.1% vs 67.6%). Improvements in HAQ-DI, PsAQoL, pain and fatigue were maintained to Wk48. In patients with ≥3% skin involvement at baseline (60.8% CZP-patients), PASI75/90 responses were maintained from Wk24 to Wk48. Radiographic progression remained low (CFB-mTSS: Wk24=0.00, Wk48=0.13). In the safety set (N=393), adverse events (AEs) occurred in 304 patients (77.4%) and serious AEs in 39 (9.9%), including 8 serious infections (2.0%; 1 case of tuberculosis [0.3%]), and 3 deaths (0.8%). Conclusion: Clinical efficacy of CZP was maintained over 48 weeks in PsA patients with and without prior anti-TNF exposure. Low radiographic progression and improvements in PASI were maintained to Wk48. Safety profile was in line with that observed for CZP in RA.