Evidence map›Paper›PMID 39487320›Full record

Observational studyPediatric research2025

Reduction of tumor necrosis factor (TNF) in milk of women receiving anti-TNF antibody.

Lusia Sepiashvili, Avery Brydon, Christine Koroshegyi, Anna Gold, Pooja Dalvi, Sholeh Ghayoori, Mehzabin Rahman, Vivian Huang, Cynthia Maxwell, Geoffrey C Nguyen and 1 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Pediatric research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03397108 (Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease), which is not on this 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.

NCT03397108 completednot on this map

Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease

TypeobservationalSponsorThe Hospital for Sick ChildrenRan2017 to 2024Enrolled79ConditionsCrohn's Disease, Ulcerative Colitis, Healthy ControlsArmsThe IBD group was divided into 2 subgroups: with or without anti-TNF antibody use
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

11 authors.

Lusia SepiashviliDepartment of Paediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON, Canada.
Avery BrydonDepartment of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada.
Christine KoroshegyiDepartment of Psychology, The Hospital for Sick Children, Toronto, ON, Canada.
Anna GoldDepartment of Psychology, The Hospital for Sick Children, Toronto, ON, Canada.ORCID 0000-0002-7719-5673
Pooja DalviDivision of Clinical Pharmacology and Toxicology, Department of Paediatrics, The Hospital for Sick Children, Toronto, ON, Canada.
Sholeh GhayooriDivision of Clinical Pharmacology and Toxicology, Department of Paediatrics, The Hospital for Sick Children, Toronto, ON, Canada.
Mehzabin RahmanDivision of Clinical Pharmacology and Toxicology, Department of Paediatrics, The Hospital for Sick Children, Toronto, ON, Canada.
Vivian HuangDivision of Gastroenterology, Mount Sinai Hospital, Toronto, ON, Canada.ORCID 0000-0002-4524-9403
Cynthia MaxwellDepartment of Gynecology, Women's College Hospital, Toronto, ON, Canada.ORCID 0000-0003-4734-1251
Geoffrey C NguyenDivision of Gastroenterology, Mount Sinai Hospital, Toronto, ON, Canada.
Shinya ItoDepartment of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada. shinya.ito@sickkids.ca.ORCID 0000-0002-4498-3075

Funding

CIHRSenior Investigator Award from the Crohn’s and Colitis Foundation of America
6 · The paper itself

Abstract

backgroundTumor Necrosis Factor (TNF) are expressed in milk. Experimental data indicate enhanced brain growth and cognitive development in the mouse offspring given milk deficient in TNF and TNF-dependent chemokines. Although monoclonal antibodies against TNF (TNFmAb) are used during breastfeeding due to minimal milk excretion, whether it affects endogenous TNF levels in human milk is unclear.

methodsA prospective cohort study was conducted in 26 breastfeeding women with inflammatory bowel disease (IBD) and 31 non-IBD women. Milk TNF and related chemokines were measured at 5-6 weeks postpartum (early-lactation point) as a primary endpoint and further determined at 13-14 weeks postpartum. In a subset of their infants, neurocognitive development was assessed at 12 and 18 months of age using Bayley-III tool.

resultsWhile milk TNF levels were not significantly different between the control and those with IBD, women with IBD receiving TNFmAb showed 70% lower median milk TNF than those without TNFmAb (P = 0.019) at early lactation period. TNF-dependent chemokines (MIP-1β and IP-10) also showed similar patterns. Neurocognitive development of the infants was not significantly different among the groups.

conclusionsWomen with IBD receiving TNFmAb show significantly lower milk TNF/chemokines at 5-6 weeks postpartum than those without TNFmAb. CLINICALTRIALS: gov NCT03397108. IMPACT: We found that milk concentrations of Tumor Necrosis Factor (TNF) and TNF-dependent chemokines (MIP-1β and IP-10) are low in women with inflammatory bowel disease who are receiving anti-TNF monoclonal antibody (TNFmAb), compared to those without concurrent anti TNF therapy. While maternal use of TNFmAb during breastfeeding is considered inconsequential to infant health due to their low levels of milk excretion, it affects profiles of endogenous cytokines in milk. Our findings provide a rationale to investigate human implications of the animal data in the literature that suggest enhancement of neurocognitive development of the offspring fed with milk deficient in TNF-dependent chemokines.

Indexed as

Antibodies, MonoclonalInflammatory Bowel DiseasesMilk, HumanTumor Necrosis Factor-alphaAdultBreast FeedingChemokinesChild DevelopmentCognitionFemaleHumansInfantLactationProspective StudiesAntibodies, MonoclonalChemokinesTumor Necrosis Factor-alpha

Identifiers

PMID39487320

What OpenQuestion holds

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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.