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  • Review Article
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Validation of new biomarkers in systemic autoimmune diseases

Nature Reviews Rheumatology volume 7, pages 708–717 (2011)Cite this article

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Abstract

Biomarkers have an important influence on the clinical decision-making processes involved in diagnosis, assessment of disease activity, allocation of treatment, and determining prognosis. The clinical usefulness of a biomarker is dependant on demonstration of its validity. Ideally, biomarkers should provide information not available from currently available tests and should be tested as they would be used in clinical practice; however, potential biomarkers could be affected by many different clinical or patient variables—such as disease activity, therapeutic intervention, or the presence of comorbidities—and validation studies might not include all the design features that are required to ensure that the biomarker is a true measure of the clinical process it is intended to reflect. In this Review, we appraise studies that have been conducted to validate six promising new biomarkers for diagnosis, disease activity assessment, or prognosis in patients with systemic autoimmune diseases. We discuss the validity of these six biomarkers with particular reference to the features of the studies that lend weight to or distract from their findings. The intent of this discussion is to draw attention to elements of validation study design that should be considered when evaluating the robustness of a biomarker, which differ according to the marker's intended use.

Key Points

  • Biomarkers are important for making informed decisions in the clinic, including those concerning diagnosis and allocation of treatment, as well as for assessing disease activity and prognosis

  • The clinical usefulness of any biomarker depends on the demonstration of its validity for a particular purpose

  • In the validation of biomarkers intended to aid diagnosis, greater attention needs to be placed on controlling or adjusting for the demographic and clinical characteristics of the disease being studied

  • Longitudinal studies are essential in the assessment of validity for biomarkers relating to disease activity and prognosis

  • New biomarkers of the greatest value are those that provide information that cannot be gained from existing tests

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Acknowledgements

This work was supported in part by the Intramural Research Program, National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, USA.

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Authors and Affiliations

  1. First Department of Internal Medicine, School of Medicine, National University of Athens, 75 M Asias Street, 11527, Athens, Greece

    Maria G. Tektonidou

  2. Room 4-1339, Building 10 CRC, National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, 10 Center Drive, Bethesda, 20892, MD, USA

    Michael M. Ward

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M. G. Tektonidou and M. M. Ward contributed equally to researching the data for the article, discussing the content, writing the article and reviewing and/or editing of the manuscript before submission.

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Correspondence to Michael M. Ward.

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Tektonidou, M., Ward, M. Validation of new biomarkers in systemic autoimmune diseases. Nat Rev Rheumatol 7, 708–717 (2011). https://doi.org/10.1038/nrrheum.2011.157

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