Immunogenicity of biological therapeutics: from assay to patient

To give an overview of the current knowledge on assay techniques and clinical implications of immunogenicity of biological therapeutics.

Assay techniques for the measurement of immunogenicity have improved, expanding the understanding of the immune response against biological therapeutics. Knowledge on the clinical effect of immunogenicity enables the treatment of patients in a targeted fashion, as a step towards personalized medicine.

Biological medications are able to induce an antidrug immune response. Immunogenicity impairs clinical response and is associated with adverse events. Several confounding factors influence the measurement of immunogenicity, including drug interference and background problems. Concomitant administration of methotrexate lowers the frequency and amount of antibodies formed, whereby the efficacy of biologicals is improved. Algorithms for therapeutic drug monitoring could aid in adapting treatment strategies in a controlled setting.