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Biologics registers in RA: methodological aspects, current role and future applications

Nature Reviews Rheumatology volume 13, pages 503–510 (2017)Cite this article

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Abstract

The beginning of the 21st century saw a biopharmaceutical revolution in the treatment of inflammatory rheumatic diseases, particularly rheumatoid arthritis. The fast-evolving use of biologic therapies highlighted the need to develop registers at national and international levels with the aim of collecting long-term data on patient outcomes. Over the past 15 years, many biologics registers have contributed a wealth of data and provided robust and reliable evidence on the use, effectiveness and safety of these therapies. The unavoidable challenges posed by the continuous introduction of new therapies, particularly with regard to understanding their long-term safety, highlights the importance of learning from experience with established biologic therapies. In this Perspectives article, the role of biologics registers in bridging the evidence gap between efficacy in clinical trials and real-world effectiveness is discussed, with a focus on methodological aspects of registers, their unique features and challenges and their role going forward.

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Figure 1: Timeline showing the founding of European biologics registers for rheumatoid arthritis.
Figure 2: Strengths and challenges of biologics registers.

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Authors and Affiliations

  1. Department of Academic Rheumatology, UK; and at the Department of Rheumatology, Weston Education Centre, Denmark Hill Campus, King's College London, London SE5 9RJ, Whittington Hospital, Magdala Avenue, London N19 5NF, UK.,

    Elena Nikiphorou

  2. and at the Department of Rheumatology, Whittington Hospital, Magdala Avenue, London N19 5NF, UK.,

    Elena Nikiphorou

  3. Leeds Institute of Rheumatic and Musculoskeletal Medicine, Chapel Allerton Hospital; and at the National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK.,

    Maya H. Buch

  4. and at the National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK.,

    Maya H. Buch

  5. Division of Musculoskeletal and Dermatological Sciences, National Institute for Health Research (NIHR) Manchester Musculoskeletal Biomedical Research Unit, Manchester Academic Health Science Centre, Central Manchester University Hospitals NHS Foundation Trust; and at the Arthritis Research UK Centre for Epidemiology, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, Stopford Building, University of Manchester, Oxford Road, Manchester M13 9PT, UK.,

    Kimme L. Hyrich

  6. Division of Musculoskeletal and Dermatological Sciences, and at the Arthritis Research UK Centre for Epidemiology, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, Stopford Building, University of Manchester, Oxford Road, Manchester M13 9PT, UK.,

    Kimme L. Hyrich

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All authors researched the data for the article, provided substantial contributions to discussions of its content, wrote the article and undertook review and/or editing of the manuscript before submission.

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Correspondence to Kimme L. Hyrich.

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Competing interests

K.L.H. declares that she has received honoraria from Abbvie and Pfizer. M.H.B. declares that she has received grants from Pfizer and Roche and has been on the advisory board and/or provided lectures for Abbvie, Bristol-Myers Squibb, Pfizer, Roche and UCB. E.N. declares no competing interests.

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Key findings on overall and solid organ cancer risk in biologic-exposed patients with rheumatoid arthritis (RA) (PDF 210 kb)

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Key findings on haematological cancer* risk in biologic-exposed patients with rheumatoid arthritis (RA) (PDF 154 kb)

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Key findings on skin cancer risk in biologic-exposed patients with rheumatoid arthritis (RA) (PDF 85 kb)

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Nikiphorou, E., Buch, M. & Hyrich, K. Biologics registers in RA: methodological aspects, current role and future applications. Nat Rev Rheumatol 13, 503–510 (2017). https://doi.org/10.1038/nrrheum.2017.81

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