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Safety of biologics in rheumatoid arthritis: data from randomized controlled trials and registries

Authors Codreanu C, Damjanov N

Received 6 June 2014

Accepted for publication 21 October 2014

Published 27 January 2015 Volume 2015:9 Pages 1—6


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Editor who approved publication: Dr Doris Benbrook

Catalin O Codreanu,1 Nemanja Damjanov2

1Rheumatology Department, Center of Rheumatic Diseases, Bucharest, Romania; 2Institute of Rheumatology, School of Medicine, University of Belgrade, Belgrade, Serbia

Abstract: Over the past decade, the use of biologics has significantly changed the management of rheumatoid arthritis (RA). Biologics selectively target components of the immune system, resulting in better disease control. However, the growing use of biologics in RA has increased safety concerns among rheumatologists. Randomized controlled trials (RCTs) and registries are the most reliable sources of clinical safety data. Although safety data from RCTs provide certain insights into the clinical safety profile of an agent, strict constraints in study design (eg, exclusion criteria and restrictive treatment protocols) often do not accurately reflect possible safety issues in the use of the agent, either in the clinical setting or over long-term treatment. Registries, on the other hand, are not restrictive regarding patient enrollment, making them more reliable in evaluating long-term safety. A number of registries have been established globally: in Europe, the United States, and Asia. However, the availability of registry data from Eastern Europe is lacking. The notable exceptions so far are registries from the Czech Republic (ATTRA, a registry of patients treated with anti-tumor necrosis factor-alpha drugs) and Serbia (National registry of patients with rheumatoid arthritis in Serbia [NARRAS]). The current report provides an overview of safety data with biologics in RA from RCTs and registries. Availability of regional safety data from Eastern Europe is of great importance to its clinicians for making evidence-based treatment decisions in RA.

Keywords: biologic therapy, biologic drugs, adverse events, infections, pregnancy, malignancies

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