162 Efficacyand safety of certolizumab pegol over four years in psoriatic arthritis patientswith and without concomitant use of DMARDs

Abstract

Background: Previous analyses from RAPID-PsA (NCT01087788) found that patients with psoriatic arthritis (PsA) treated with certolizumab pegol (CZP) exhibited similar improvements in symptoms, over four years, with and without concomitant DMARD use at baseline. We report long-term efficacy and safety of CZP with and without concomitant DMARD use. Methods: RAPID-PsA was double-blind and placebo-controlled to Week (Wk) 24, dose-blind to Wk48 and open-label to Wk216. Patients had active PsA with ≤1 failed DMARD. Patients were randomised to CZP 200mg Q2W or 400mg Q4W at baseline or, for a third of patients, after 16 or 24-week (wk) placebo treatment. All CZP-treated patients received loading doses of 400mg at Wks 0, 2, 4, and continued their assigned dose to open-label. We report efficacy for patients randomised to CZP at baseline and safety data for all patients who received ≤1 dose of CZP throughout the study, in patients with and without DMARD use at baseline (DMARD+ and DMARD). The primary clinical endpoint of ACR20 response at Wk12 is reported as % of responders among observed cases through Wk216. Treatmentemergent adverse events (TEAEs) were classified by severity; serious infections, and deaths were reported. Results: 393 patients received ≤1 dose of CZP, of whom 279 were DMARD+ and 114 were DMARD patients at baseline. 273 patients received CZP from Wk0, of whom 26/199 (13.1%) DMARD+ patients discontinued DMARDs, and 5/74 (6.8%) DMARD patients initiated DMARDs during the study, and continued their use concomitantly with CZP to Wk216. 141/199 (70.9%) DMARD+ and 42/74 (56.8%) DMARD patients completed Wk216. Efficacy of CZP in DMARD+ and DMARD patients was maintained over four years (DMARD+: ACR20 at Wk12=61.7%; n=183, Wk216=79.7%; n=143; DMARD: ACR20 at Wk12=52.1%; n=71, Wk216=83.3%; n=42). Total CZP exposure during the study was 1,321 patient-years. TEAE incidence rates were 163.2/100 patient-years (DMARD+) and 160.2/100 patient-years (DMARD). Investigators classified 62.2% of TEAEs mild and 34.9% of TEAEs moderate in severity. Severe TEAE incidence rates were 5.4/ 100 patient-years for DMARD+ and 7.2/100 patient-years for DMARD patients. 26.2% DMARD+ and 23.7% DMARD patients reported serious TEAEs. The most common serious TEAEs, grouped within MedDRA system organ class infections and infestations, were reported by 16 (5.7%) DMARD+(incidence rate: 1.7/100 patientyears) and 7 (6.1%) DMARD patients (incidence rate: 2.0/100 patientyears). Malignant neoplasms were reported by four DMARD+ patients (breast [two cases], one metastatic gastrointestinal cancer, and one lymphoma) and 2 DMARD patients (one breast, one ovarian). Six deaths were reported during the RAPID-PsA study (myocardial infarction, cardiac arrest, sudden death, pneumonia and sepsis [same patient], breast cancer, and lymphoma), five of which were DMARD+ patients. Conclusion: Patients enrolled in RAPID-PsA and treated with CZP, with and without concomitant DMARD use, had similar efficacy and safety profiles. No new safety signals were identified.