Subcutaneous infliximab for maintenance therapy in children and adolescents with inflammatory bowel disease: a systematic review and meta-analysis.

Subcutaneous infliximab is licensed for maintenance only in adults with inflammatory bowel disease, and pediatric evidence sits in small cohorts never pooled. We estimated the effectiveness, pharmacokinetics, immunogenicity, and safety of subcutaneous infliximab as maintenance therapy in children and adolescents with inflammatory bowel disease. We searched MEDLINE, Embase, Web of Science, CENTRAL, and trial registries from inception to 12 July 2026. Eligible studies were observational cohorts and case series of at least five children under 18 years old treated with subcutaneous infliximab after a switch from intravenous infliximab or de novo. Single-arm proportions were pooled with a random-effects model. Five cohorts (162 children; 113 [70%] Crohn disease, 45 [28%] ulcerative colitis, 4 [2%] unclassified) were included. Over a median follow-up of about 6 months (range 12 weeks to 12 months), treatment persistence was 89.8% (95% CI 72.6-99.0) and clinical remission at the closest timepoint to 6 months was 90.2% (61.3-100). Serum infliximab concentration roughly doubled after the switch (pooled mean 11.4 to 21.9 µg/mL), and new antidrug antibodies were rare (0.7%). Clinical relapse occurred in 4.8%, serious adverse events in 1.5%, and injection site reactions in 11.0%. Certainty of evidence was low to very low.

conclusionIn children with inflammatory bowel disease, subcutaneous infliximab maintained clinical remission and sustained drug exposure after a switch from intravenous therapy, with low discontinuation and an acceptable safety profile. Because almost all children switched while in remission, these data do not establish that de novo initiation can induce remission and need prospective confirmation. PROTOCOL REGISTRATION: PROSPERO CRD420261469356 (registered 4 August 2026). WHAT IS KNOWN: • Subcutaneous infliximab maintains steady drug exposure and is licensed for maintenance treatment only in adults with inflammatory bowel disease; pediatric use is off-label and rests on small single-center cohorts. WHAT IS NEW: • In this first meta-analysis confined to children (five cohorts, 162 patients), treatment persistence and clinical remission rate were both near 90%, serum concentrations roughly doubled after the switch, and serious adverse events were rare.