Gastroenterology & Hepatology (G&H)When Should Pediatric Inflammatory Bowel Disease Patients Be Allowed to Take Approved Therapies for Adults?

🎓 Expert Commentary / Peer Perspective
In a Gastroenterology & Hepatology Q&A, Michael Kappelman, MD, MPH (UNC Chapel Hill) addresses extrapolation of adult IBD therapies to pediatric patients, noting that only infliximab and adalimumab carry FDA pediatric IBD approval, with ustekinumab recently approved by the EMA for pediatric Crohn’s disease.

Clinical Considerations

• Extrapolation from adult efficacy data is generally reasonable for older children and adolescents, given shared genetics, pathophysiology, and historical response patterns.
• Caution applies to very early-onset IBD (under 6 years) and infantile-onset IBD, where monogenic defects and altered drug clearance may shift the calculus.
• Pediatric-specific safety data remain limited, with concerns including hepatosplenic T-cell lymphoma risk in thiopurine plus anti-TNF combinations and higher infection exposure from school-age social contact.
• Shared decision-making should involve clinician, parents, and child at a developmentally appropriate level, with payor authorization processes recognized as a barrier rather than a participant.

Practice Applications

• Consider a second anti-TNF agent for secondary loss of response driven by immunogenicity before moving out of class.
• Recognize that diminishing returns of sequential medical therapy may make surgical evaluation more appropriate than continued switching in some pediatric patients.
• Monitor growth, pubertal development, nutritional status, mental health, and adherence alongside disease activity in adolescents on advanced therapies.
• Integrate mucosal healing goals with clinical and biochemical remission status when weighing whether to switch therapy in a clinically well child.