Advances in Clinical and Experimental Medicine

Title abbreviation: Adv Clin Exp Med
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Advances in Clinical and Experimental Medicine

2018, vol. 27, nr 4, April, p. 493–499

doi: 10.17219/acem/68737

Publication type: original article

Language: English

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Efficacy and safety of golimumab as add-on therapy to standard disease-modifying antirheumatic drugs: Results of the GO-MORE study in the Polish population

Sławomir Jeka1,A,B,D,E,F, Bogdan Batko2,B,C,D,E,F, Mariusz Korkosz3,B,C,D,E,F, Maria Majdan4,B,C,D,E,F, Brygida Kwiatkowska5,B,C,D,E,F, Iwona Dankiewicz-Fares1,B,C,D,E,F, Jerzy M. Sobiecki6,C,D,E,F, Włodzimierz Samborski7,B,C,D,E,F

1 Department of Rheumatology and Connective Tissue Diseases, The Jan Biziel University Hospital No. 2, Nicolaus Copernicus University in Torun, Collegium Medicum in Bydgoszcz, Poland

2 Department of Rheumatology, The Józef Dietl Specialist Hospital, Kraków, Poland

3 Division of Rheumatology, Department of Internal Medicine and Gerontology, Jagiellonian University Medical College, Kraków, Poland

4 Department of Rheumatology and Connective Tissue Diseases, Medical University of Lublin, Poland

5 Department of Early Arthritis, National Institute of Geriatrics, Rheumatology and Rehabilitation, Warszawa, Poland

6 Department of Medical Affairs, Merck Sharp & Dohme, Warszawa, Poland

7 The Wiktor Dega Orthopedic-Rehabilitative Clinical Hospital, Poznań, Poland

Abstract

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.
Conclusion. 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.

Key words

methotrexate, rheumatoid arthritis, golimumab, disease-modifying antirheumatic drugs

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