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BIOLOGIC THERAPY IN RHEUMATOID ARTHRITIS: RESULTS FROM THE ROMANIAN REGISTRY OF RHEUMATIC DISEASES ONE YEAR AFTER INITIATION

CĂTĂLIN CODREANU^1*, CORINA MOGOȘAN¹, RUXANDRA IONESCU², IOAN ANCUȚA³, DANIELA OPRIȘ²

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The extensive use of biologics in the treatment of rheumatoid arthritis (RA) has called for a long-term evaluation of the efficacy and safety of this therapy. Patient registries are currently used to provide real-life information on long-term efficacy and safety of biologics, thus overcoming limitations imposed by methodologies of clinical studies. Limited data are available from registries in Central and Eastern Europe. "The Romanian Registry of Rheumatic Diseases" (RRBR) is an electronic application that includes data of all RA patients treated with biologics in Romania. This observational, prospective study initiated in February 2013, collected multiple variables: demographics, RA therapies, disease activity, adverse events, in order to provide data for RA patients in our country. This is the first published report presenting data for 4499 RA patients treated with biologics included in the RRBR. The average age of participants is 57.70 years, 85.3% are women, with a mean disease duration of 12.62 years. 58.45% of the patients are treated with a tumour necrosis factor (TNF) alpha inhibitors and 41.55% with Rituximab. Six months after initiating a biologic therapy, delta DAS28 dropped by 3.29; 41.1% of the patients who continued therapy maintained remission (mean DAS28 = 2.58). Only 473 adverse events were recorded, mostly infections. Nevertheless, safety data are insufficient due to poor reporting of adverse effects.