Post by Basic & Clinical Pharmacology & Toxicology

Can anti-drug antibodies be detected before they cross the manufacturer's positivity threshold? Therapeutic drug monitoring (TDM) is widely used to optimise treatment with infliximab and adalimumab. However, manufacturer-defined thresholds for anti-drug antibodies (ADA) may not always capture low-level immunogenicity in real-world clinical samples. In a new short communication, Lise Pedersen explores the use of the signal-to-noise (S/N) ratio as a supplementary measure for detecting low-titre ADA in a large TDM cohort. 📊 Key findings: • S/N ratios enabled detection of ADA signals below the manufacturers' positivity thresholds. • Several samples previously classified as ADA negative, indeterminate, or double negative could be re-classified as ADA positive based on S/N values. • Elevated S/N ratios in some double-negative samples suggest early or low-titre immunogenicity close to the detection limits of the assays. • S/N may provide a valuable complement to fixed ADA positivity thresholds in clinical TDM. These findings highlight the importance of assay validation and suggest that S/N ratios may improve the detection of clinically relevant immunogenicity in patients receiving infliximab or adalimumab. Congratulations to Lise Pedersen on this contribution to the field. Read the article 👇 https://lnkd.in/ezVgr3kt #TherapeuticDrugMonitoring #Immunogenicity #Infliximab #Adalimumab