THU0224 Renacer study: efficacy and safety assessment of czp therapy in the treatment of 501 patients with rheumatoid arthritis(RA) among spanish population in clinical practice

Abstract

BackgroundCertolizumab PEGol (CZP) differs from other anti-TNFs in that it is monovalent and it lacks the Fc region found in monoclonal antibodies. CZP is also PEGylated. Its efficacy in patients with rheumatoid arthritis (RA) has been evaluated in previous clinical trials.ObjectivesThe purpose of the current study is to assess effectiveness, safety and survival rate in patients with RA after 12 months of treatment and also within specific subgroups, in clinical practice settings.MethodsObservational longitudinal prospective study of RA patients from 40 sites in Spain. Variables (baseline, 3- and 12 month assessment): socio-demographics, smoking status, previous synthetic DMARD (sDMARD) and biological DMARD (bDMARD) use; TJC, SJC, ESR, CRP, DAS28. Response variables EULAR Moderate/Good Response and DAS28 remission and Safety were assessed. Descriptive, comparative and Logistic regression analyses were performed. Kaplan-Meier survival curve was performed.ResultsA total of 501 patients were included: 78.6% women, mean age 53.6 year (±13.2 SD) and 77% were aged <65 year Mean disease duration 7.5 year (±7.3 SD) and 27.7% having early RA. Baseline features are shown in table 1. Mean number of prior sDMARD 1.5 (±1.1 SD). Mean number of prior bDMARD was 0.8 (±1.2 SD). Mean duration of exposure to CZP was 9.8 months (±3.4 SD); Concomitant steroids intake 12.6%, sDMARD 24.2% and sDMARD plus steroids 54.9%; Smoking status: 69.8% never smoked, 12.9% former smoker and 17.3% current smoker.Baseline predictors of response: lower prior number sDMARD; low number prior bDMARD; higher CRP, ESR, TJC, SJC and DAS28 (p<0.05) scores.Patients<65 year had shown better DAS28 Remission rates as well as those who had previously received <2 sDMARDs, those who were “bionaïve” at CZP initiation and those who used CZP in combination.CZP survival rates are shown in Figures 1 and 2.Adverse effects from treatment were reported in 65 patients (13%), mostly mild.ConclusionsCZP showed benefit in active RA patients, with clear improvement in all clinical parameters, mostly in <65 yo patients and those who had received low number of previous sDMARD and bDMARD. Survival rate at 12 month assessment was high, demonstrating a reasonable safety profile.Reference[1] Torrente-Segarra V, et al; (RENACER StudyGroup). RENACER study:Assessment of 12-month efficacy and safety of 168 certolizumab PEGol rheumatoidarthritis-treated patients from a Spanish multicenter national database. ModRheumatol2015Nov 7:1–6.Disclosure of InterestNone declared