Immunogenicity of Therapeutic Antibodies: Monitoring Antidrug Antibodies in a Clinical Context

Karien Bloem, Borja Hernández-Breijo, Ana Martínez-Feito, Theo Rispens

Research output: Contribution to journalArticleAcademicpeer-review

52 Citations (Scopus)

Abstract

One of the factors that may impact drug levels of therapeutic antibodies in patients is immunogenicity, with potential loss of efficacy. Nowadays, many immunogenicity assays are available for testing antidrug antibodies (ADA). In this article, we discuss different types of immunogenicity assays and their clinical relevance in terms of drug tolerance, relation with pharmacokinetics (PK), neutralizing antibodies, potential adverse events associated with ADA, and prediction of ADA production. Drug-tolerant assays can provide insight into the process of immunogenicity, but for clinical management, these assays do not necessarily outperform drug-sensitive assays. The usefulness of any ADA assay for clinical decision making will be larger when drug concentrations are also measured, and this is true, in particular, for drug-tolerant assays
Original languageEnglish
Pages (from-to)327-332
JournalTherapeutic drug monitoring
Volume39
Issue number4
Early online date2017
DOIs
Publication statusPublished - 2017

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