North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition position paper on the therapeutic drug monitoring in pediatric inflammatory bowel disease.

Abstract

Inflammatory bowel diseases (IBD) require effective therapies to prevent morbidity and maintain quality of life. The introduction of biologic agents, beginning with monoclonal antibodies targeting tumor necrosis factor (TNF) alpha, has launched a new era of advancements that have markedly improved short- and long-term outcomes of Crohn's disease and ulcerative colitis. Along with these improvements, there have been challenges to address in optimizing use of biologic therapies in children with IBD. Young children may have rapid drug clearance, and growing children have changing medication needs related to changes in body size, metabolism, and development. For these and other reasons, one size (one dose) does not fit all. Therapeutic drug monitoring (TDM), which involves measurement of drug concentration in serum usually, typically at the predose trough, has emerged as a valuable tool for optimizing dosing and preventing pharmacokinetic failure. This society paper reviews the use of TDM, including target ranges during induction and maintenance therapy for anti-TNF agents and for emerging biologics. This report has been compiled by pediatric gastroenterologists on behalf of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition IBD committee after extensive review of the current literature. The purpose of this clinical position statement is to provide guidance to clinicians in the use of TDM to optimize the treatment of children with IBD.