EFFICACY AND SAFETY OF GOLIMUMAB AS ADD-ON THERAPY TO DISEASE-MODIFYING ANTIRHEUMATIC DRUGS IN RHEUMATOID ARTHRITIS: RESULTS OF THE GO-MORE STUDY IN ROMANIA

Autor:	Cluj-Napoca Pharmacy, Catalin Codreanu, Craiova Pharmacy, Simona Rednic, Anca Rosu, M. Suta, Iasi Pharmacy, Lorena Petcu, Rodica Chireac, I. Ancuta, Bucharest Pharmacy, M. Parvu, Ruxandra Ionescu, Merck Sharpe Dohme Romania, Bucharest, Romania
Rok vydání:	2015
Předmět:	musculoskeletal diseases medicine.medical_specialty business.industry Disease medicine.disease Golimumab Add on therapy Internal medicine Rheumatoid arthritis Medicine General Materials Science skin and connective tissue diseases Antirheumatic drugs business medicine.drug
Zdroj:	Romanian Journal of Rheumatology. 24:207-213
ISSN:	2069-6086 1843-0791
DOI:	10.37897/rjr.2015.4.4
Popis:	Objectives. GO-MORE was an open-label, multinational, prospective observational study in patients with active rheumatoid arthritis (RA) in typical clinical practice settings in 40 countries. The trial involved patients with active rheumatoid arthritis despite treatment with disease modifying antirheumatic drugs (DMARDs) and naïve to biological agents. Considering the different countries demographic or disease characteristics, we analysed the efficacy and safety data of the Romanian subpopulation in this paper. Method. The patients received subcutaneous GOL 50 mg once a month for a period of 6 months. The primary endpoint was the percentage of patients with a good and moderate EULAR DAS28-ESR response after 6 months of treatment. Results. A total of 51 patients with active RA with an average disease duration of 3.53 years and an average DAS28 of 6.15 at baseline were included. All patients were taking DMARDs (66% patients were taking methotrexate (MTX) and 23.5% leflunomide (LEF) in monotherapy; the others were taking other background therapies or combinations of them). All these 51 patients received GOL 50 mg once a month. After 6 months 78.4% of patients showed a good or moderate EULAR response, most of them (68.6%) after the first administration; 27.5% showed low DAS28-ESR and 7.8% were in remission. GOL was well tolerated and the safety profile was consistent with the findings of previous studies. The number of serious side effects (12%) or which lead to discontinuation of therapy (8%) was generally low. Conclusions. The addition of subcutaneous GOL 50 mg once a month to different DMARDs in patients with active RA yielded a moderate or good EULAR DAS28-ESR response after 6 month in a proportion of 78.4% of patients in Romania. The response was observed after the first administration of GOL. The safety profile is consistent with other clinical trials with antiTNFi in RA with no new safety signals detected.
Databáze:	OpenAIRE
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