Immunogenicity of Anti-TNF-α Biotherapies: II. Clinical Relevance of Methods Used for Anti-Drug Antibody Detection
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Immunogenicity of biopharmaceuticals is complex and influenced by both structural and pharmacological factors, and by patient-related conditions such as disease being treated, previous and concomitant therapies, and individual immune responsiveness. Essential for tailored therapeutic strategies based on immunopharmacological evidence from individual patients (personalized medicine) is the use of assays for anti-drug antibodies (ADA) that are accurate and relevant in the clinical setting. This paper discusses immunogenicity of genetically engineered immunoglobulins directed against tumor-necrosis factor-α (TNF). Emphasis will be on commonly used methods for detection of ADA in human serum including issues that question the clinical applicability of these methodologies. The use of dubious assays for ADA in a clinical context may not only contribute to confusion as to the importance of drug immunogenicity but may also prevent development of safe and cost-effective ways of using biological TNF-antagonists.
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ADA response may result in the formation of immune complexes with the mAbs; immune complexes are more likely cleared via FcγR-mediated endocytosis at a different rate than mAb alone and accelerate (or less frequently delay) the overall mAb clearance.
“ADA response may result in the formation of immune complexes with the mAbs. Varying in size and structure, immune complexes are more likely cleared via FcγR‐mediated endocytosis at a different rate than mAb alone (faster or sometimes slower) and accelerate (or less frequently delay) the overall mAb clearance.45”
From Tutorial on monoclonal antibody pharmacokinetics and its considerations in early development (2018) · cites this paper as [45]
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- Authors
- Bendtzen, K.
- Affiliations
- Copenhagen University Hospital (DK)
- Corresponding author
- Bendtzen, Klaus
- Venue
- Frontiers in Immunology
- Publisher
- Frontiers Media SA
- Published
- 2015-04-08
- Volume
- 6
- Pages
- 109-109
- ISSN
- 1664-3224 (ISSN-L)
- PMC
- PMC4389574
- OpenAlex
- W2000987573
- Cited by
- 73
- References
- 16
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 3 · 2023: 2 · 2022: 9 · 2021: 5 · 2020: 10 · 2019: 9 · 2018: 10 · 2017: 7 · 2016: 11 · 2015: 1
- FWCI
- 4.77
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Frontiers in Immunology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- 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
- immunogenicity, anti-drug antibodies, TNF antagonists, assay validation, personalized medicine
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