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Subcutaneous infliximab maintains clinical remission and shows high tolerability in children with inflammatory bowel diseaseSwitching to Subcutaneous Infliximab Maintains Remission in Children with IBD

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Key Takeaway
Consider subcutaneous infliximab as a tolerable, effective alternative to intravenous infliximab for maintaining remission in children.

This meta-analysis evaluates the transition from intravenous to subcutaneous infliximab in children with inflammatory bowel disease. The analysis included a total of 173 patients to assess clinical outcomes, pharmacokinetics, and tolerability following the switch in administration route.

Key findings indicate a 93% rate for maintenance of clinical remission and a 92% rate for treatment persistence. Pharmacokinetic data showed steady-state SC concentrations were roughly 2-fold above prior IV troughs. Immunogenicity was low, with new anti-drug antibody formation reported as rare (4 out of 129). The study also reported an 8% rate for any-cause discontinuation, attributed to injection-site intolerance, disease relapse, or paradoxical dermatitis. Patient and caregiver satisfaction was high, and the treatment was noted for excellent tolerability.

Limitations include the fact that the treatment is not approved for patients under 18 years of age and the evidence is dispersed across small, largely observational cohorts. Despite these limitations, the transition to infliximab-SC appears to sustain remission with predictable pharmacokinetics and a reassuring immunogenicity profile in appropriately selected children.

How this fits prior evidence

This meta-analysis confirms the finding that subcutaneous infliximab maintains clinical remission and doubles serum concentrations in pediatric inflammatory bowel disease. It builds upon the established pharmacokinetic profile of the transition from intravenous to subcutaneous administration while providing specific data on treatment persistence (92%) and low immunogenicity (4 out of 129) in a pediatric cohort.

Researchers analyzed data regarding children with inflammatory bowel disease who switched from intravenous to subcutaneous infliximab. The study looked at how well the medication worked, how well it was tolerated, and whether it stayed in the system effectively. The findings showed a 93% rate for maintaining clinical remission and a 92% rate for treatment persistence.

Safety and tolerability were reported as high, with many patients and caregivers expressing satisfaction with the subcutaneous method. Only 8% of patients stopped treatment for reasons like skin issues or disease relapse. Additionally, the study found that drug levels remained steady and the formation of new antibodies against the drug was rare.

It is important to note that this specific treatment is not yet approved for patients under 18 years old. The evidence also comes from several small and observational groups. While the results are encouraging for the transition to subcutaneous delivery, patients and families should talk to their doctors to determine the best treatment plan.

What this means for you:
Switching to subcutaneous infliximab shows high remission rates and good tolerability in children with IBD.

Common questions

Is subcutaneous infliximab effective for children with IBD?

The study found a 93% rate for maintaining clinical remission in children who switched from intravenous to subcutaneous infliximab. The results also showed a 92% rate for treatment persistence, suggesting the medication remains effective for the majority of patients who make the switch.

How well is the subcutaneous treatment tolerated by patients?

The treatment showed high patient and caregiver satisfaction and excellent tolerability. Only 8% of patients discontinued the treatment due to issues like injection-site intolerance, disease relapse, or paradoxical dermatitis. The formation of new anti-drug antibodies was also reported as rare.

Is this treatment approved for all children?

No, this specific treatment is not currently approved for patients under 18 years old. Additionally, the evidence is based on small, observational cohorts. You should consult with a medical professional to discuss the best options for a specific child's care.

Study Details

Study typeMeta analysis
EvidenceLevel 1
Follow-up216.0 mo
PublishedOct 2026
View Original Abstract ↓
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.
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