Switching from Intravenous to Subcutaneous Infliximab in Children with Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis.

PURPOSE OF REVIEW: Subcutaneous infliximab (IFX-SC; CT-P13 SC/infliximab-dyyb/Remsima-SC/Zymfentra) is an approved maintenance option after intravenous (IV) induction in adults with inflammatory bowel disease (IBD), but it is not approved for patients < 18 years, and the pediatric evidence remains dispersed across small, largely observational cohorts. This review synthesizes the published pediatric experience of transitioning from IV to SC infliximab, examining maintenance of remission, drug concentrations, safety, and acceptability, and situates it within the adult evidence base and the distinctly pediatric concerns of access and dosing.

RECENT FINDINGS: A systematic search (PROSPERO: CRD420261465026) identified six independent, non-overlapping pediatric switch cohorts (n = 173). Random-effects proportional meta-analysis yielded pooled treatment persistence of 92% (95%CI 84-98), maintained clinical remission of 93% (95%CI 84-99), and any-cause discontinuation of 8% (95%CI 2-16), most often for injection-site intolerance, disease relapse, or paradoxical dermatitis. New anti-drug antibody formation was rare among the 129 children in cohorts measuring immunogenicity (four children, none sustained) while previously positive antibodies frequently resolved after switching. Steady-state SC concentrations ran roughly 2-fold above prior IV troughs, an expected step-up reflecting sustained subcutaneous exposure. Patient and caregiver satisfaction was high due to decreased school absence and travel, and cost analyses signaled net savings from avoided infusion-center use. The principal barrier was administrative: age-based denial. In appropriately selected children, transition to IFX-SC sustains remission with predictable pharmacokinetics, a reassuring immunogenicity profile, and excellent tolerability, mirroring the adult experience. These observations constitute a well-supported real-world signal and warrant prospective validation and pursuit of pediatric labeling.