Pharmacokinetics‐Based Dosing Strategies for Therapeutic Proteins in Inflammatory Bowel Disease

This chapter explains the rational behind the concept of pharmacokinetics-guided dosing and dashboards, and the expected benefit of dashboards in improving therapy with monoclonal antibodies in inflammatory disease. It outlines a brief description of the various dosing strategies (both the induction and maintenance phases). In four dosing strategies, induction phase doses were administered as a two-hour intravenous infusion fixed at 5 mg kg-1 at Weeks 0, 2, and 6 as per label recommendations. Maintenance phase doses varied depending on the strategy: label dosing, stepwise adaptive dosing, proportional adaptive dosing, and Bayesian adaptive dosing. The goal of adaptive dosing strategies using Bayesian systems is to identify a dose/dosing frequency that maximizes the likelihood of an individual patient achieving a target exposure associated with an improved clinical outcome. The development of Bayes dosing systems in inflammatory bowel diseases currently presents challenges in defining how the development and implementation of such devices are funded, reimbursed, and implemented clinically.