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  • Review Article
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Safety of biologic therapy in rheumatoid arthritis

Nature Reviews Rheumatology volume 7, pages 639–652 (2011)Cite this article

Subjects

Abstract

Biologic therapies have revolutionized the treatment of rheumatic diseases in the past decade. As with any drugs, however, a variety of important safety concerns affect the choice and use of these agents. Several issues, such as the risk of infection, malignancy, or administration reactions, apply to all of these compounds, although some conditions that affect patient selection and management within these categories seem to be specific to particular biologic treatments. Other safety concerns with biologic agents, such as congestive heart failure, demyelinating disease, and hyperlipidemia, are associated with individual agents. Despite all these concerns, the therapeutic indices for biologic agents remain fairly high in relation to non-biologic DMARDs. Available safety data for all biologic agents approved for the treatment of rheumatoid arthritis are reviewed in this manuscript. With careful patient selection and appropriate vigilance on the part of treating physicians and other care providers, these compounds can be safely integrated into the therapeutic plan.

Key Points

  • Although randomized, controlled trials provide important initial information about the safety of new therapeutic agents, post-marketing data are often necessary to understand the true risk of specific adverse events

  • Infections remain the greatest safety concern with biologic therapies; no single agent carries a clearly reduced overall risk of infection in comparison with the others

  • The risk of specific infections, such as tuberculosis, seems to be higher with some biologic agents than with others

  • Screening for latent tuberculosis in all patients can reduce the risk of reactivation of this infection with TNF inhibitor therapy

  • Whereas the overall risk of solid malignancies does not seem to increase with biologic therapy, the risk of non-melanoma skin cancer is increased with TNF inhibitor therapy

  • TNF inhibitors may be used during pregnancy if clinically indicated; insufficient data guide the potential use of other biologic agents during pregnancy

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Figure 1: Summary of biologic therapies used in the treatment of rheumatoid arthritis.

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Acknowledgements

C. P. Vega, University of California, Irvine, CA, is the author of and is solely responsible for the content of the learning objectives, questions and answers of the Medscape, LLC-accredited continuing medical education activity associated with this article.

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  1. Division of Rheumatology, Department of Medicine, Northwestern University Feinberg School of Medicine, 240 East Huron Street, McGaw M300, Chicago, 60611, IL, USA

    Robert S. Woodrick & Eric M. Ruderman

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R. S. Woodrick and E. M. Ruderman contributed equally to all aspects of the preparation of this manuscript.

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Correspondence to Eric M. Ruderman.

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E. M. Ruderman is a consultant for Amgen, Abbott, Roche, Wyeth/Pfizer and UCB, and has received research support from Abbott, Centocor and Roche. R. Woodrick declares no competing interests.

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Woodrick, R., Ruderman, E. Safety of biologic therapy in rheumatoid arthritis. Nat Rev Rheumatol 7, 639–652 (2011). https://doi.org/10.1038/nrrheum.2011.145

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