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Background <p>Subcutaneous infliximab (SC-IFX) offers an alternative to intravenous infliximab (IV-IFX) in adults with inflammatory bowel disease (IBD), but evidence in children is scarce. This study reports treatment persistence, tolerability, and pharmacokinetics in a real-world pediatric IBD cohort following transition from IV-IFX.</p> Methods <p>We conducted a single center retrospective study including all pediatric IBD patients transitioned from IV-IFX to SC-IFX (120&#xa0;mg every other week) at our institution between November 2023 and April 2025. Clinical disease activity scores, inflammatory markers, IFX serum concentrations, and anti-IFX antibodies (AIA) were assessed at baseline and during follow-up. The primary outcome was treatment persistence. Secondary outcomes included disease activity, pharmacokinetics, immunogenicity and tolerability.</p> Results <p>Twenty patients (median age 14.5 years; range 5–17), including six children &lt; 12 years and five weighing &lt; 40&#xa0;kg, were included. After a median observation period of 44 weeks (IQR 26–60), 16/20 patients (80%) remained on SC-IFX, with no significant difference between Crohn’s disease and ulcerative colitis. In a subgroup of four patients who received SC-IFX as a third dose following two intravenous induction doses, 3/4 (75%) maintained treatment over a median observation period of 60 weeks (range 16–64 weeks) and remained in clinical remission during follow-up. IFX serum concentrations increased after switching (median 11.8&#xa0;µg/mL pre-switch vs. ≥24&#xa0;µg/mL at follow-up), with most follow-up measurements reaching the assay ceiling. Concentrations were descriptively comparable between weight groups. All patients with detectable AIA prior to switching became antibody-negative during SC-IFX therapy, and no de novo antibodies were observed. Two patients discontinued therapy due to worsening of pre-existing paradoxical psoriasis. No other adverse events were documented.</p> Conclusions <p>SC-IFX showed high persistence, stable inflammatory markers and good tolerability in this pediatric cohort, including younger and lower-weight children. SC-IFX appears to be a feasible maintenance option in selected pediatric patients, including early use after induction. Prospective studies are warranted to define pediatric-specific pharmacokinetic targets and individualized dosing strategies.</p>

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Subcutaneous infliximab as a maintenance option in pediatric IBD: a real-world cohort including younger and lower-weight children

  • 期刊论文

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  • 发表日期：

    2026年7月17日

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  • Neele Ridder,
  • Johanna Overberg,
  • Laura Kalveram,
  • Samipa Pudasaini,
  • Caroline Ruppel,
  • Leonie Schumm,
  • Stephan Henning,
  • Philip Bufler

摘要

Background

Subcutaneous infliximab (SC-IFX) offers an alternative to intravenous infliximab (IV-IFX) in adults with inflammatory bowel disease (IBD), but evidence in children is scarce. This study reports treatment persistence, tolerability, and pharmacokinetics in a real-world pediatric IBD cohort following transition from IV-IFX.

Methods

We conducted a single center retrospective study including all pediatric IBD patients transitioned from IV-IFX to SC-IFX (120 mg every other week) at our institution between November 2023 and April 2025. Clinical disease activity scores, inflammatory markers, IFX serum concentrations, and anti-IFX antibodies (AIA) were assessed at baseline and during follow-up. The primary outcome was treatment persistence. Secondary outcomes included disease activity, pharmacokinetics, immunogenicity and tolerability.

Results

Twenty patients (median age 14.5 years; range 5–17), including six children < 12 years and five weighing < 40 kg, were included. After a median observation period of 44 weeks (IQR 26–60), 16/20 patients (80%) remained on SC-IFX, with no significant difference between Crohn’s disease and ulcerative colitis. In a subgroup of four patients who received SC-IFX as a third dose following two intravenous induction doses, 3/4 (75%) maintained treatment over a median observation period of 60 weeks (range 16–64 weeks) and remained in clinical remission during follow-up. IFX serum concentrations increased after switching (median 11.8 µg/mL pre-switch vs. ≥24 µg/mL at follow-up), with most follow-up measurements reaching the assay ceiling. Concentrations were descriptively comparable between weight groups. All patients with detectable AIA prior to switching became antibody-negative during SC-IFX therapy, and no de novo antibodies were observed. Two patients discontinued therapy due to worsening of pre-existing paradoxical psoriasis. No other adverse events were documented.

Conclusions

SC-IFX showed high persistence, stable inflammatory markers and good tolerability in this pediatric cohort, including younger and lower-weight children. SC-IFX appears to be a feasible maintenance option in selected pediatric patients, including early use after induction. Prospective studies are warranted to define pediatric-specific pharmacokinetic targets and individualized dosing strategies.