TY - JOUR T1 - 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis JF - RMD Open JO - RMD Open DO - 10.1136/rmdopen-2017-000582 VL - 4 IS - 1 SP - e000582 AU - Désirée van der Heijde AU - Atul Deodhar AU - Oliver FitzGerald AU - Roy Fleischmann AU - Dafna Gladman AU - Alice B Gottlieb AU - Bengt Hoepken AU - Lars Bauer AU - Oscar Irvin-Sellers AU - Majed Khraishi AU - Luke Peterson AU - Anthony Turkiewicz AU - Jürgen Wollenhaupt AU - Philip J Mease Y1 - 2018/03/01 UR - http://rmdopen.bmj.com/content/4/1/e000582.abstract N2 - Objective To report the efficacy, patient-reported, radiographic and safety outcomes of 4 years’ certolizumab pegol (CZP) treatment in patients with psoriatic arthritis (PsA).Methods RAPID-PsA (NCT01087788) was double-blind and placebo-controlled to Week 24, dose-blind to Week 48 and open-label (OL) to Week 216. Patients were randomised 1:1:1 to either placebo or CZP 200 mg every 2 weeks (Q2W) or 400 mg every 4 weeks (Q4W) (following 400 mg at Weeks 0/2/4). Patients randomised to CZP continued their assigned dose in the OL period. Patients randomised to placebo were re-randomised to CZP 200 mg Q2W or 400 mg Q4W (post-loading dose) at Week 16 (early escape) or after the double-blind phase. We present observed and imputed data; missing values were imputed using non-responder imputation (NRI) for categorical and last observation carried forward (LOCF) for continuous measures.Results 409 patients were randomised; 20% (54/273) of Week 0 patients randomised to CZP had prior anti-tumour necrosis factor (TNF) exposure; 67% (183/273) completed 216 weeks. By Week 48, 60.4% of patients achieved Disease Activity Index for Psoriatic Arthritis low disease activity or remission, which was maintained; 66.3% achieved these outcomes at Week 216 (NRI). At Weeks 48 and 216, 39.2% of patients achieved minimal disease activity (NRI). 75% reduction in Psoriasis Area and Severity Index responses were 65% and 52% at Weeks 48 and 216 (NRI). Total resolution rates for enthesitis, dactylitis and nail psoriasis, at 4 years, were 71%, 81% and 65%, respectively (LOCF). Structural damage progression was low over 4 years’ treatment. No new safety signals were identified after Week 96.Conclusions CZP efficacy in treating PsA was maintained over 4 years, in patients both with and without prior anti-TNF exposure, with no new safety signals identified. ER -