Signal-to-noise ratio to assess magnitude,kinetics and impact on pharmacokinetics ofthe immune response to an adalimumabbiosimilar: supplementary material

Background: The antidrug antibody (ADA) signal-to-noise (S/N) ratio was explored as a novelimmunogenicity measure to evaluate the immune response of healthy subjects to a single dose of GP2017,an adalimumab biosimilar. Methodology/results: Bioanalytical methods used for the analysis of ADA S/Nratios and ADA titers were validated for sensitivity, precision and drug interference. ADA S/N ratiosstrongly correlated with ADA titers. Correlations between ADA area under the curve and ADAmax andpharmacokinetics (PK) were stronger for ADA S/N ratio than for ADA titers. Conclusion: ADA S/N ratioallowed for a more sensitive evaluation of themagnitude and kinetics of the immune response, was bettercorrelated with adalimumab PK and was superior to ADA titers in assessing the impact of the immuneresponse on PK.