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Immunogenicity of biologic agents in rheumatology

Lookup NU author(s): Professor John IsaacsORCiD


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© 2020, Springer Nature Limited.Biologic agents have become a core component of therapeutic strategies for many inflammatory rheumatic diseases. However, perhaps reflecting the specificity and generally high affinity of biologic agents, these therapeutics have been used by rheumatologists with less consideration of their pharmacokinetics than that of conventional synthetic DMARDs. Immunogenicity was recognized as a potential limitation to the use of biologic agents at an early stage in their development, although regulatory guidance was relatively limited and assays to measure immunogenicity were less sophisticated than today. The advent of biosimilars has sparked a renewed interest in immunogenicity that has resulted in the development of increasingly sensitive assays, an enhanced appreciation of the pharmacokinetic consequences of immunogenicity and the development of comprehensive and specific guidance from regulatory authorities. As a result, rheumatologists have a greatly improved understanding of the field in general, including the factors responsible for immunogenicity, its potential clinical consequences and the implications for everyday treatment. In some specialties, immunogenicity testing is becoming a part of routine clinical management, but definitive evidence of its cost-effectiveness in rheumatology is awaited.

Publication metadata

Author(s): Strand V, Goncalves J, Isaacs JD

Publication type: Review

Publication status: Published

Journal: Nature Reviews Rheumatology

Year: 2021

Volume: 17

Issue: 2

Pages: 81-97

Print publication date: 01/02/2021

Online publication date: 14/11/2020

Acceptance date: 03/11/2020

ISSN (print): 1759-4790

ISSN (electronic): 1759-4804

Publisher: Nature Research


DOI: 10.1038/s41584-020-00540-8

PubMed id: 33318665