Cited by 58Biosimilars and Bioanalytical MethodsMonoclonal and Polyclonal Antibodies ResearchRheumatoid Arthritis Research and Therapies

Biological anti-TNF drugs: immunogenicity underlying treatment failure and adverse events

Prado, Mônica Simon, Bendtzen, Klaus, Andrade, Luis Eduardo Coelho·2017·Expert Opinion on Drug Metabolism & Toxicology

Abstract

INTRODUCTION: Genetically engineered monoclonal antibodies and fusion proteins directed against cytokines or their receptors represent a breakthrough in the treatment of various chronic immune-inflammatory diseases. Areas covered: Studies show high remission rates in several diseases, but clinical practice shows a significant percentage of individuals who do not exhibit the desired response. Loss of therapeutic benefit after initial successful response is designated secondary failure. Immune-biological agents are not self-antigens and are therefore potentially immunogenic. Secondary failure is frequently caused by antibodies against immune-biologicals, known as anti-drug antibodies (ADA). ADA that neutralize circulating immune-biologicals and/or promote their clearance can reduce treatment efficacy. Furthermore, ADA can induce adverse events by diverse immunological mechanisms. This review provides a comprehensive overview of ADA in rheumatoid arthritis patients treated with anti-TNF immune-biologicals, and explores the concept of therapeutic drug monitoring (TDM) as an effective strategy to improve therapeutic management. Expert opinion: Monitoring circulating ADA and therapeutic immune-biological drugs is helpful when evaluating patients with secondary failure. However, immunological tests for ADA vary considerably regarding their ability to detect different types of ADA. Several assays are not designed to determine ADA-induced drug neutralizing capacity, and they may report clinically non-relevant data, especially if drug is present in test samples.

Integrity signals

Registry

Crossref · 10.1080/17425255.2017.1360280

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61 of 61 references verified0 citation errors · 0 not checkable

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  • Studies have shown that ADA response in rheumatoid arthritis patients treated with anti-TNF immunobiologicals leads to loss of therapeutic benefit after an initial positive response.

    “For example, studies have shown that ADA response in rheumatoid arthritis patients treated with anti‐TNF immunobiologicals leads to loss of therapeutic benefit after an initial positive response.46”

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Authors
Prado, M. S., Bendtzen, K., & Andrade, L. E. C.
Affiliations
  • Universidade Federal de São Paulo (BR)
  • Rigshospitalet (DK)
  • Rheumatology Division, Escola Paulista de Medicina, Universidade Federal de São Paulo, Sao Paulo, Brazil
Venue
Expert Opinion on Drug Metabolism & Toxicology
Published
2017-08-14
Volume
13
Issue
9
Pages
985-995
ISSN
  • 1742-5255 (ISSN-L)
  • 1744-7607
OpenAlex
W2744702511
Cited by
58
References
61
Citations by year
2026: 3 · 2025: 7 · 2024: 4 · 2023: 10 · 2022: 5 · 2021: 4 · 2020: 10 · 2019: 7 · 2018: 8
FWCI
0.70
Type
journal article
Language
en
Open access
closed
Locations
  • Expert Opinion on Drug Metabolism & Toxicology (publishedVersion)
  • PubMed (publishedVersion)
  • UNIFESP Institutional Repository (Universidade Federal de São Paulo) (submittedVersion)
Topics
  • Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
  • Health Sciences › Medicine › Rheumatology › Rheumatoid Arthritis Research and Therapies
Keywords
anti-TNF drugs, anti-drug antibodies, immunogenicity, secondary treatment failure, rheumatoid arthritis, therapeutic drug monitoring, adverse drug reactions
MeSH terms
Animals, Antibodies, Antibodies, Monoclonal, Arthritis, Rheumatoid, Biological Factors, Humans, Inflammation, Tumor Necrosis Factor-alpha, Drug Monitoring, Treatment Failure, Antirheumatic Agents

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