Background Registries are becoming an increasingly important source of data, providing additional information on the use of biologics in clinical practice. The real-world clinical data currently available regarding the use of SC anti-TNFs is still limited. Therefore, it is of utmost importance to increase the knowledge of Golimumab (GLM) effectiveness in the clinical practice.
Objectives This study was designed to access the effectiveness of SC GLM 50 mg/monthly + MTX through 52 weeks of treatment in biologic-naïve RA patients. The primary objective was to investigate the proportion of patients achieving clinical remission (DAS28ESR<2.6). The secondary objectives were the evaluation of: the treatment persistence rates; the proportion of patients achieving functional response (ΔHAQ>0.22); and the effect of treatment on DAS28 individual components.
Methods This was a retrospective non-interventional study based on the Rheumatic Diseases Portuguese Register (Reuma.pt). It was conducted in a cohort of patients aged >18 years with active RA despite previous treatment with conventional DMARDs, biologic-naïve, who started SC GLM+MTX, from March 2011 to August 2015. The cumulative incidence of achieving clinical remission, treatment persistence and functional response/remission were estimated using survival analysis. Cox regression was used to calculate the hazard ratios.
Results A total of 109 patients (86.3% female, mean age 55.5±13.2 years; mean age of diagnosis 45.5±13.5 years, rheumatoid factor 78% positive) met the study criteria. Ninety-three had a follow up of at least 52 weeks (i.e. all patients who started treatment before August 2014). At week 52, 38.3% of patients were on clinical remission, 91.9% achieved functional response and 35.2% were on functional remission (HAQ<0.5). The treatment persistence rate was 75.3% for the individuals who were in the study for ≥52 weeks (Figure 1). For functional remission, high CRP levels at baseline seem to be a determining factor (HR=0.54, p=0.026).
Conclusions This is the first Golimumab data analysis generated from the Portuguese registry Reuma.pt. Our results are in agreement with data from other national registries and demonstrate the long-term effectiveness and the high treatment persistence rates of GLM through 52 weeks.
Disclosure of Interest A. F. Mourão Consultant for: Merck Sharp & Dohme, C. Ribeiro: None declared, J. Borges: None declared, M. J. Gonçalves: None declared, M. Bernardes: None declared, S. Fernandes: None declared, R. Dezerto Employee of: Merck Sharp & Dohme, P. A. Laires Employee of: Merck Sharp & Dohme, P. Machado Employee of: Merck Sharp & Dohme, M. Eusébio: None declared, M. J. Santos: None declared, H. Canhão: None declared