Evidence map›Paper›PMID 38167922›Full record

ArticleInflammatory bowel diseases2024

Infliximab Monotherapy vs Combination Therapy for Pediatric Crohn's Disease Exhibit Similar Pharmacokinetics.

Ruben J Colman, Stephanie A Vuijk, Ron A A Mathôt, Johan Van Limbergen, Maria M E Jongsma, Marco W J Schreurs, Phillip Minar, Lissy de Ridder, Geert R A M D'Haens

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Inflammatory bowel diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Article
  2. Observational
  3. Article
  4. Article
  5. Observational
  6. Article
  7. Review
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

9 authors.

Ruben J ColmanDivision of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.ORCID 0000-0001-9891-8570
Stephanie A VuijkDepartment of Pediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.
Ron A A MathôtDepartment of Hospital Pharmacy & Clinical Pharmacology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands.
Johan Van LimbergenDepartment of Pediatric Gastroenterology and Nutrition, Amsterdam University Medical Centers, University of Amsterdam, Emma Children's Hospital, Amsterdam, the Netherlands.
Maria M E JongsmaDepartment of Pediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.
Marco W J SchreursDepartment of Immunology, Erasmus MC, Rotterdam, the Netherlands.
Phillip MinarDivision of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.ORCID 0000-0003-4223-4211
Lissy de RidderDepartment of Pediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.
Geert R A M D'HaensDepartment of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism, Meibergdreef 9, Amsterdam, the Netherlands.

Funding

Stem Cell/Organoid and Genome Editing CoreP30DK078392 · NIDDK · CINCINNATI CHILDRENS HOSP MED CTR · PI James M Wells · 2007 to 2026
$24.4M
PEDIATRIC GASTROENTEROLOGY AND NUTRITION TRAINING GRANTT32DK007727 · NIDDK · CINCINNATI CHILDRENS HOSP MED CTR · PI Phillip P Minar · 1995 to 2026
$11.3M
Precise Infliximab Exposure and Pharmacodynamic Control to Achieve Deep Remission in Pediatric Crohn's DiseaseR01DK132408 · NIDDK · CINCINNATI CHILDRENS HOSP MED CTR · PI Phillip P Minar · 2022 to 2026
$3.5M
Therapeutic Monitoring and Targeting of Neutrophil Activation in Pediatric IBDK23DK105229 · NIDDK · CINCINNATI CHILDRENS HOSP MED CTR · PI MINAR, PHILLIP P · 2015 to 2018
$734k
Pharmacokinetic Evaluation to Optimize Infliximab Monotherapy with Personalized Pharmacodynamic BiomarkersR03DK118314 · NIDDK · CINCINNATI CHILDRENS HOSP MED CTR · PI MINAR, PHILLIP P · 2018 to 2019
$239k
Netherlands Organisation for Health Research and Development 113202001NIDDK NIH HHS K23 DK105229NIDDK NIH HHS P30 DK078392NIDDK NIH HHS R01 DK132408NIDDK NIH HHS R03 DK118314NIDDK NIH HHS T32 DK007727
6 · The paper itself

Abstract

backgroundThe use of concomitant azathioprine may improve efficacy and pharmacokinetic (PK) properties of infliximab (IFX) but is also associated with an increased risk of adverse events. Proactive therapeutic drug monitoring (pTDM) of IFX monotherapy is an alternative strategy to improve PK. The aim of this study was to evaluate whether IFX with an immunomodulator (combo) has PK benefits over IFX-pTDM (mono) in pediatric Crohn's disease (CD).

methodsThis PK analysis included pediatric CD patients who started either IFX combo (TISKids study) or IFX mono with pTDM (REFINE cohort). Combo and mono IFX trough levels (TLs) and antibodies-to-infliximab were assessed at infusion 3, 4, and 5. A population PK model was built to compare IFX PK outcomes (clearance [CL], TLs and cumulative exposure) between combo and mono groups at infusion 4 and 5. Clinical response and steroid-free clinical remission (SFCR) was assessed at infusion 4 and 5.

resultsThis study included 128 pediatric CD patients (66 mono and 62 combo). At infusion 5, there was no significant difference between mono and combo median TLs 4.1 µg/mL (2.1, 7.8) vs 5.9 µg/mL (3.2, 9.4; P = .14) or median CL 0.26 L/d (0.21, 0.32) vs 0.26 L/d (0.21, 0.33; P = .81). Mono patients had a lower SFCR rate at infusion 5 (53% [31 of 59] vs 80% [32 of 40]; P = .01). Clinical response rates were significantly higher among combo than mono patients at both infusion 4 and 5.

conclusionsThis study suggests that there are no PK differences (TLs and CL) between combo and mono therapy in pediatric CD patients who started IFX.

Indexed as

Crohn DiseaseDrug Therapy, CombinationGastrointestinal AgentsInfliximabAdolescentAzathioprineChildDrug MonitoringFemaleHumansImmunosuppressive AgentsMaleTreatment OutcomeAzathioprineGastrointestinal AgentsImmunosuppressive AgentsInfliximabanti-TNF therapychildrenimmunomodulatorinflammatory bowel diseasepharmacokinetics

Identifiers

PMID38167922
PMCPMC12102478

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.