Evidence map›Paper›PMID 36934327›Full record

Trial reportJournal of Crohn's & colitis2023

Serum Immune Profiling in Paediatric Crohn's Disease Demonstrates Stronger Immune Modulation With First-Line Infliximab Than Conventional Therapy and Pre-Treatment Profiles Predict Clinical Response to Both Treatments.

Maria M E Jongsma, Lea M M Costes, Irma Tindemans, Martinus A Cozijnsen, Rolien H C Raatgreep, Merel van Pieterson, Yunlei Li, Johanna C Escher, Lissy de Ridder, Janneke N Samsom

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of Crohn's & colitis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02517684 (Top-down Infliximab Study in Kids With Crohn's Disease), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
5.6field-weighted citation impact, top 4% of its field
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.

NCT02517684 phase4completednot on this map

Top-down Infliximab Study in Kids With Crohn's Disease

TypeinterventionalSponsorErasmus Medical CenterRan2015 to 2024Enrolled100ConditionsCrohn's DiseaseArmsInfliximab, Prednisolone, Exclusive enteral nutrition, Azathioprine
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 18 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Observational
  10. Precision medicine in inflammatory bowel disease.Precision clinical medicine · 2023
    Review
  11. 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

10 authors at 2 institutions in 1 country.

Maria M E JongsmaDepartment of Pediatric Gastroenterology, Erasmus University Medical Center/Sophia Children's Hospital, Rotterdam, the Netherlands.
Lea M M CostesLaboratory of Pediatrics, Division of Gastroenterology and Nutrition, Erasmus University Medical Center/Sophia Children's Hospital, Rotterdam, the Netherlands.
Irma TindemansLaboratory of Pediatrics, Division of Gastroenterology and Nutrition, Erasmus University Medical Center/Sophia Children's Hospital, Rotterdam, the Netherlands.
Martinus A CozijnsenDepartment of Pediatric Gastroenterology, Erasmus University Medical Center/Sophia Children's Hospital, Rotterdam, the Netherlands.
Rolien H C RaatgreepLaboratory of Pediatrics, Division of Gastroenterology and Nutrition, Erasmus University Medical Center/Sophia Children's Hospital, Rotterdam, the Netherlands.
Merel van PietersonDepartment of Pediatric Gastroenterology, Erasmus University Medical Center/Sophia Children's Hospital, Rotterdam, the Netherlands.
Yunlei LiDepartment of Pathology & Clinical Bioinformatics, Erasmus University Medical Center/Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
Johanna C EscherDepartment of Pediatric Gastroenterology, Erasmus University Medical Center/Sophia Children's Hospital, Rotterdam, the Netherlands.
Lissy de RidderDepartment of Pediatric Gastroenterology, Erasmus University Medical Center/Sophia Children's Hospital, Rotterdam, the Netherlands.
Janneke N SamsomLaboratory of Pediatrics, Division of Gastroenterology and Nutrition, Erasmus University Medical Center/Sophia Children's Hospital, Rotterdam, the Netherlands.
Erasmus MC · NLErasmus MC Cancer Institute · NL

Funding

ZonMw
6 · The paper itself

Abstract

backgroundDespite its efficacy, rational guidance for starting/stopping first-line biologic treatment in individual paediatric Crohn's disease [CD] patients is needed. We assessed how serum immune profiles before and after first-line infliximab [FL-IFX] or conventional [CONV] induction therapy associate with disease remission at week 52.

methodsPre- [n = 86], and 10-14-week post-treatment [n = 84] sera were collected from patients with moderate-to-severe paediatric CD in the TISKids trial, randomized to FL-IFX [n = 48; five 5-mg/kg infusions over 22 weeks] or CONV [n = 43; exclusive enteral nutrition or oral prednisolone]; both groups received azathioprine maintenance. The relative concentrations of 92 inflammatory proteins were determined with Olink Proteomics; fold changes [FC] with |log2FC| > 0.5 after false discovery rate adjustment were considered significant.

resultsFL-IFX modulated a larger number of inflammatory proteins and induced stronger suppression than CONV; 18/30 proteins modulated by FL-IFX were not regulated by CONV. Hierarchical clustering based on IFX-modulated proteins at baseline revealed two clusters of patients: CD-hi patients had significantly higher concentrations of 23/30 IFX-modulated proteins [including oncostatin-M, TNFSF14, HGF and TGF-α], and higher clinical disease activity, C-reactive protein and blood neutrophils at baseline than CD-lo patients. Only 24% of CD-hi FL-IFX-treated patients maintained remission without escalation at week 52 vs 58% of CD-lo FL-IFX-treated patients. Similarly, 6% of CD-hi CONV-treated patients achieved remission vs 20% of CONV-treated CD-lo patients. Clustering based on immune profiles post-induction therapy did not relate to remission at week 52.

conclusionFL-IFX leads to stronger reductions and modulates more immune proteins than CONV. Stratification on pre-treatment profiles of IFX-modulated proteins directly relates to maintenance of remission without treatment escalation. TRIAL REGISTRATION NUMBER: NCT02517684.

Indexed as

Crohn DiseaseAzathioprineChildC-Reactive ProteinGastrointestinal AgentsHumansInfliximabRemission InductionTreatment OutcomeAzathioprineC-Reactive ProteinGastrointestinal AgentsInfliximabanti-TNFinflammatory bowel diseaseProteomics

Identifiers

PMID36934327
PMCPMC10441564
OpenAlexW4327843895

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.