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Subcutaneous infliximab maintains clinical remission and doubles serum concentrations in pediatric inflammatory bowel diseaseSubcutaneous infliximab maintains remission for children with inflammatory bowel disease

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Key Takeaway
Note that subcutaneous infliximab maintains remission and increases serum levels after switching from intravenous therapy.

This meta-analysis evaluates the efficacy and safety of subcutaneous infliximab for maintenance therapy in children and adolescents with Crohn's disease and ulcerative colitis. The analysis included 162 patients and focused on treatment persistence, clinical remission, pharmacokinetics, and immunogenicity.

Key findings indicate that patients receiving subcutaneous infliximab achieved a treatment persistence of 89.8% (95% CI 72.6-99.0) and a clinical remission rate of 90.2% at approximately 6 months (61.3-100). Pharmacokinetic data showed that serum infliximab concentrations roughly doubled after switching from intravenous therapy, increasing from 11.4 to 21.9 µg/mL. The incidence of new antidrug antibodies was 0.7%. The safety profile was noted as acceptable, with injection site reactions occurring in 11.0% of cases and serious adverse events in 1.5% of cases.

The authors note that the evidence for these findings is of low to very low certainty. Additionally, the data do not establish that de novo initiation of subcutaneous infliximab can induce remission. Clinically, the findings suggest that subcutaneous infliximab is a viable option for maintaining remission and sustaining drug exposure following a switch from intravenous therapy.

How this fits prior evidence

This meta-analysis addresses a gap in the management of pediatric inflammatory bowel disease by evaluating subcutaneous infliximab. While other evidence explores preclinical targets like the palmitoylation cycle or experimental treatments like extracellular vesicle-based therapies, this study provides data on a currently used therapeutic switch. It specifically addresses the maintenance of clinical remission and serum concentration levels in children and adolescents with Crohn's disease and ulcerative colitis.

Managing inflammatory bowel disease in children and adolescents is a constant balancing act. Families and doctors look for ways to keep kids in remission while ensuring the medication stays effective in their systems. Recent data looks at what happens when these young patients switch from intravenous (IV) infusions to subcutaneous (under the skin) injections of the drug infliximab.

In a review of 162 patients, the results showed that the switch to subcutaneous injections helped maintain treatment persistence at nearly 90 percent. Additionally, about 90 percent of the children reached clinical remission at the six-month mark. The study also found that the amount of medicine in the blood roughly doubled after the switch, which helps keep the drug working effectively.

While the results are promising for maintaining treatment, the evidence is currently of low to very low certainty. It is important to note that this data only looks at patients already on the drug; it does not prove that starting the medication for the first time via injection will work the same way. Most children tolerated the switch well, with only a small number reporting minor issues like reactions at the injection site.

What this means for you:
Switching to subcutaneous infliximab can help children with inflammatory bowel disease stay in remission and maintain drug levels.

Common questions

Is subcutaneous infliximab safe for children with Crohn's disease?

The study reported an acceptable safety profile for children and adolescents. While some children experienced injection site reactions (11.0 percent), only 1.5 percent experienced serious adverse events. You should discuss these specific safety results and your child's needs with their doctor.

How does the drug level change when switching to injections?

When patients switched from intravenous to subcutaneous infliximab, the concentration of the medicine in their blood roughly doubled. This helps ensure the drug remains effective for maintaining clinical remission in children with inflammatory bowel disease.

Does this mean the injection works for new patients?

The current data does not establish that starting the medication for the first time (de novo initiation) using an injection will induce remission. The study specifically looked at patients who were already on the treatment and switched methods.

Study Details

Study typeMeta analysis
Sample sizen = 162
EvidenceLevel 1
PublishedSep 2026
View Original Abstract ↓
UNLABELLED: 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. CONCLUSION: In 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.
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