Immunogenicity Publication Bias and Its Consequences for Predictive Models: A Call for Transparent Reporting

Understanding immunogenicity is crucial to improving therapeutic protein development. By comparing Phase I to III antidrug antibody (ADA) incidence data of Roche-internal and approved monoclonal antibodies, we demonstrate a bias toward lower ADA incidence in published data, partly because ADA data from early trials-often discontinued for reasons related to high immunogenicity-are rarely published. Through an empirical model, we show how this bias affects ADA incidence time-course predictions, underscoring the need for cross-industry transparent data reporting.