Background: The GO-MORE study was an open-label, multinational, prospective study that investigated the efficacy and safety of adding golimumab to synthetic disease-modifying antirheumatic drugs (sDMARDs) in patients with active rheumatoid arthritis (RA).
Objectives: The aim of this study was to assess the efficacy and safety of golimumab add-on therapy in the Polish subpopulation of the GO-MORE study.
Material and methods: Patients were administered 50 mg subcutaneous doses of golimumab once a month for 6 months, while continuing therapy with sDMARDs and/or glucocorticoids (GCS). The primary clinical endpoint was the proportion of patients with moderate or good European League Against Rheumatism (EULAR) response based on the 28-joint disease activity score (DAS28) erythrocyte sedimentation rate (ESR) after 6 months.
Results: The Polish subpopulation (129 patients) was similar to the overall study population (3,280 patients) with regard to age, sex, mean baseline DAS28, inflammatory markers, average methotrexate dose, and GCS use; however, they had a longer disease duration (median: 6.04 vs 4.9 years) and more Polish patients (85.9% vs 78.7%) had high disease activity (DAS28-ESR ≥3.2). At 6 months, 84.5% of Polish patients showed good or moderate EULAR response, 26.4% had low disease activity and 17.1% were in clinical remission, compared with 82.9%, 37.4% and 23.9%, respectively, in the overall study population. Golimumab safety profile was consistent with previous studies and comparable to the overall study population.
Conclusions: The addition of golimumab to sDMARD therapy in Polish RA patients showed good or moderate EULAR DAS28-ESR response in 84.5% of patients, mirroring the overall study population.
Keywords: disease-modifying antirheumatic drugs; golimumab; methotrexate; rheumatoid arthritis.