Bioanalytics – Biomolecular
Mechanisms driving anti-drug immunogenicity remain uncertain and reliable biomarkers to predict immunogenicity development are lacking. Here, high-throughput flow cytometry was used to identify a unique phenotypic signature associated with the development of nADA in patients with multiple sclerosis (MS) patients treated with IFN-β and rheumatoid arthritis (RA) treated with TNFα-inhibitors. Baseline predictors of nADA development were identified and validated in two cross sectional cohorts and prospective cohorts followed before and after biopharmaceutics administration. This work has identified novel mechanisms influencing the development of immunogenicity to biopharmaceuticals and a potential biomarker to predict anti-drug responses. Our findings have clear implications for treatment of patients with multiple sclerosis and potentially other patient groups treated with biopharmaceuticals.