TY - JOUR
T1 - Immunogenicity of Therapeutic Antibodies: Monitoring Antidrug Antibodies in a Clinical Context
AU - Bloem, Karien
AU - Hernández-Breijo, Borja
AU - Martínez-Feito, Ana
AU - Rispens, Theo
PY - 2017
Y1 - 2017
N2 - 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
AB - 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
U2 - https://doi.org/10.1097/FTD.0000000000000404
DO - https://doi.org/10.1097/FTD.0000000000000404
M3 - Article
C2 - 28463887
SN - 0163-4356
VL - 39
SP - 327
EP - 332
JO - Therapeutic drug monitoring
JF - Therapeutic drug monitoring
IS - 4
ER -