Subcutaneous infliximab in children with IBD: about 90% persistence after switching, low-certainty evidence

Design

Systematic review and meta-analysis of five observational cohorts

Population

162 children with IBD switched to subcutaneous infliximab, median follow-up about 6 months

Primary outcome

Treatment persistence and clinical remission near 6 months

Effect

Persistence 89.8% (95% CI 72.6 to 99.0); remission 90.2% (61.3 to 100); mean level 11.4 to 21.9 micrograms/mL

Subcutaneous infliximab is licensed for maintenance only in adults, and paediatric data sit in small cohorts. This meta-analysis pooled five observational cohorts including 162 children and adolescents (70% Crohn disease, 28% ulcerative colitis), almost all switched from intravenous infliximab while in remission. Median follow-up was about 6 months.

Treatment persistence was 89.8% (95% CI 72.6 to 99.0) and clinical remission near 6 months was 90.2% (61.3 to 100). Serum infliximab concentrations roughly doubled after the switch, from a mean of 11.4 to 21.9 micrograms/mL. 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 was low to very low.

Because nearly all children switched while in remission, the data do not show that starting treatment this way induces remission. The wide confidence intervals reflect small cohorts and heterogeneity.

• This is off-label use in children; the licence covers maintenance in adults.
• Evidence is limited to switching children already in remission, not starting treatment.
• Drug levels rose after switching; consider therapeutic drug monitoring where available.
• Injection site reactions occurred in about one in nine children.

Why it matters

Home injection could reduce infusion visits for children and adolescents.

Don't overread it

Uncontrolled cohorts with short follow-up cannot show that the subcutaneous route is as effective as intravenous dosing.

The statistics, in plain English

A remission rate of 90.2% with an interval of 61.3 to 100 means the true rate could plausibly be anywhere from about 60% to nearly all. With five small uncontrolled cohorts, selection of good responders is likely.

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