Model‐Based Meta‐Analysis Use in the Development of Therapeutic Proteins

Model‐based meta‐analysis (MBMA) is a method for combining summary or aggregate qualitative and quantitative study data from multiple studies to develop a single conclusion that has greater statistical power than one study alone, thus facilitating decisions during drug development. This chapter focuses on the use of MBMA in the development of therapeutic proteins for immune‐mediated inflammatory disease where pharmacometric models are used to model the responses of interest. It presents the results from the development of models for the kinetics of drug action (K‐PD) using a meta‐analysis of published literature on CD and its therapies. The chapter also includes an example of MBMA results using published literature on inflammatory bowel disease studies (meta‐analysis) and the development of a K‐PD model of the time course of drug action of the biologic therapies on Crohn's Disease Activity Index (CDAI), 100‐point decrease from baseline CDAI, C‐reactive protein concentrations, and immunogenicity.