Evidence map›Paper›PMID 42283234›Full record

Observational studyJournal of pediatric gastroenterology and nutrition2026

Multiple switches between infliximab originator and biosimilars in pediatric inflammatory bowel disease.

Sofie De Groote, Karen van Hoeve, Erwin Dreesen, Ilse Hoffman

Abstract readObservational Study
In one paragraph

Observational study in Journal of pediatric gastroenterology and nutrition, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Sofie De GrooteDepartment of Pediatric, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
Karen van HoeveDepartment of Pediatric Gastroenterology & Hepatology & Nutrition, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
Erwin DreesenClinical Pharmacology and Pharmacotherapy Unit, Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium.
Ilse HoffmanDepartment of Pediatric Gastroenterology & Hepatology & Nutrition, University Hospitals Leuven, KU Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0002-2541-4117

Funding

None
6 · The paper itself

Abstract

objectivesInfliximab (IFX) is highly effective but costly, driving the adoption of biosimilars. Data on switching from originator IFX to biosimilars in pediatric inflammatory bowel disease (IBD) patients remain limited. This study evaluated the safety and efficacy of switching from originator IFX to IFX biosimilar CT-P13 in IBD.

methodsIn this single-center observational study, we investigated all pediatric patients with IBD on maintenance IFX therapy who were switched from originator (Remicade®) to CT-P13 (Inflectra®, switch A in cohort A) in 2018 and to CT-P13 (Remsima®, switch B in cohort B) in 2022. Cohort C includes patients who underwent both switches. Demographics, disease activity, remission rates and IFX trough levels were collected from 6 months before to 6 months after each switch.

resultsA total of 42 children (cohort A) and 44 children (cohort B) had a single switch to CT-P13; 14 (cohort C) had multiple switches. Median IFX trough concentration was 5.7 ([3.8-9.3) and 9.0 (6.2-11.7) µg/mL versus 6.5 (3.9-8.6) and 9.22 (7.9-10.5) µg/mL 6 months after switch in cohort A and B and 4.3 (3.4-10.9) versus 7.9 (6.9-9.7) and 9.3 (8.3-10.3) versus 9.4 (7.9-10.6) for respectively both switches in cohort C (all p > 0.05). Antibodies to IFX developed in one patient post-switch. Clinical/biological remission rates remained stable. No clinically significant changes in inflammatory biomarkers and safety profile were noted before and after switch.

conclusionsSwitching to CT-P13 biosimilars appears to maintain remission without relevant changes in pharmacokinetics, disease activity, or adverse events in pediatric patients with IBD. Further studies are required.

Indexed as

Antibodies, MonoclonalBiosimilar PharmaceuticalsDrug SubstitutionGastrointestinal AgentsInflammatory Bowel DiseasesInfliximabAdolescentChildFemaleHumansMaleRemission InductionTreatment OutcomeAntibodies, MonoclonalBiosimilar PharmaceuticalsCT-P13Gastrointestinal AgentsInfliximabanti‐TNF therapychildpharmacokineticssafety

Identifiers

PMID42283234
PMCPMC13539654

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.