Unknown

Dataset Information

0

Cross-reactive and pre-existing antibodies to therapeutic antibodies--Effects on treatment and immunogenicity.


ABSTRACT: The potential for immunogenicity is an ever-present concern during the development of biopharmaceuticals. Therapeutic antibodies occasionally elicit an antibody response in patients, which can result in loss of response or adverse effects. However, antibodies that bind a drug are sometimes found in pre-treatment serum samples, with the amount depending on drug, assay, and patient population. This review summarizes published data on pre-existing antibodies to therapeutic antibodies, including rheumatoid factors, anti-allotype antibodies, anti-hinge antibodies, and anti-glycan antibodies. Unlike anti-idiotype antibodies elicited by the drug, pre-formed antibodies in general appear to have little consequences during treatment. In the few cases where (potential) clinical consequences were encountered, antibodies were characterized and found to bind a distinct, unusual epitope of the therapeutic. Immunogenicity testing strategies should therefore always include a proper level of antibody characterization, especially when pre-formed antibodies are present. This minimizes false-positives, particularly due to rheumatoid factors, and helps to judge the potential threat in case a genuine pre-dose antibody reactivity is identified.

SUBMITTER: van Schie KA 

PROVIDER: S-EPMC4623040 | biostudies-other | 2015

REPOSITORIES: biostudies-other

Similar Datasets

2017-09-05 | E-MTAB-4669 | biostudies-arrayexpress
2023-01-16 | GSE222872 | GEO
| S-EPMC7097525 | biostudies-literature
2021-10-13 | E-MTAB-11084 | biostudies-arrayexpress
2021-10-29 | E-MTAB-11117 | biostudies-arrayexpress
| S-EPMC7290594 | biostudies-literature
| S-EPMC7860591 | biostudies-literature
2019-07-18 | GSE117146 | GEO