Evidence map›Paper›PMID 28870657›Full record

ArticleClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2018

Use of Biologic Therapy by Pregnant Women With Inflammatory Bowel Disease Does Not Affect Infant Response to Vaccines.

Dawn B Beaulieu, Ashwin N Ananthakrishnan, Christopher Martin, Russell D Cohen, Sunanda V Kane, Uma Mahadevan

Registry-linked trialOpen access · greenAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03894228 (Safety of IBD Drugs During Pregnancy and Breastfeeding), which is not on this map. Cited by 49 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 3 pooled it
11.7field-weighted citation impact, top 1% 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.

NCT03894228 recruitingnot on this mapstarted 2019, after this paper: background citation

Safety of IBD Drugs During Pregnancy and Breastfeeding: Mothers and Babies' Outcomes (DUMBO Registry)

Typeobservational_patient_registrySponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis UlcerosaRan2019 to 2028Enrolled1,750ConditionsInflammatory Bowel Diseases, Pregnancy
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 3 syntheses or guidelines pooled it, 131 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Pooled it
  4. Update on Pregnancy in Inflammatory Bowel Disease.Gastroenterology & hepatology · 2026
    Article
  5. Article
  6. Review
  7. Review
  8. Family Planning and Rheumatoid Arthritis.Current rheumatology reports · 2025
    Review
  9. Review
  10. Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Inflammatory bowel disease in pregnancy and breastfeeding.Nature reviews. Gastroenterology & hepatology · 2023
    Review
  16. Article
  17. Review
  18. Article
  19. Review
  20. Article
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

6 authors at 6 institutions in 1 country.

Dawn B BeaulieuDivision of Gastroenterology, Hepatology, and Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee.
Ashwin N AnanthakrishnanDivision of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address: aananthakrishnan@mgh.harvard.edu.
Christopher MartinDivision of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina.
Russell D CohenSection of Gastroenterology, Hepatology and Nutrition, University of Chicago Medicine, Chicago, Illinois.
Sunanda V KaneDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Uma MahadevanDivision of Gastroenterology, University of California-San Francisco, San Francisco, California.
Harvard University · USMayo Clinic · USUniversity of California, San Francisco · USUniversity of Chicago · USUniversity of North Carolina at Chapel Hill · USVanderbilt University Medical Center · US

Funding

Pilot & Feasibility ProgramP30DK043351 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI Ramnik J Xavier · 1991 to 2026
$35.3M
Genetic predictors of anti-TNF treatment response and infections in IBDK23DK097142 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI ANANTHAKRISHNAN, ASHWIN N · 2012 to 2016
$846k
NIDDK NIH HHS K23 DK097142NIDDK NIH HHS P30 DK043351
6 · The paper itself

Abstract

BACKGROUND &

aimsIn women with inflammatory bowel diseases (IBDs), exposure to immunomodulator or biologic therapy has not been associated with adverse events during pregnancy or outcomes of newborns. We investigated whether exposure of patients to these agents during pregnancy affects serologic responses to vaccines in newborns.

methodsWe collected data from the Pregnancy in IBD and Neonatal Outcomes registry, which records outcomes of pregnant women with diagnosis of IBD receiving care at multiple centers in the United States, from 2007 through 2016. Serum samples collected from infants at least 7 months old were analyzed for titers of antibodies to Haemophilus influenzae B (HiB) or tetanus toxin; mothers completed a survey of vaccine practices and outcomes from July 2013 through October 2016. Umbilical cord blood samples from 33 infants were assayed for concentration of biologic agents. Vaccination response was compared between infants born to mothers exposed to biologic therapy (infliximab, adalimumab, certolizumab pegol, golimumab, natalizumab, vedolizumab, or ustekinumab-either as a single agent or in combination with an immunomodulator, at any time between conception and delivery) and infants born to unexposed mothers.

resultsA total of 179 women completed the vaccine survey (26 biologic unexposed, 153 exposed to a biologic agent). We found no significant difference in proportions of infants with protective antibody titers against HiB born to exposed mothers (n = 42, 71%) vs unexposed mothers (n = 8, 50%) (P = .41). We also found no difference in the proportion of infants with protective antibody titers to tetanus toxoid born to exposed mothers (80%) vs unexposed mothers (75%) (P = .66). The median concentration of infliximab in cord blood did not differ significantly between infants with vs without protective antibody titers to HiB (P = .30) or tetanus toxoid (P = .93). Mild reactions were observed in 7/40 infants who received rotavirus vaccine and whose mothers had been exposed to biologic therapies.

conclusionsVaccination of infants against HiB and tetanus toxin, based on antibody titers measured when infants were at least 7 months old, does not appear to be affected by in utero exposure to biologic therapy.

Indexed as

Immunity, HumoralAdultAntibodies, BacterialBiological TherapyChild, PreschoolFemaleHaemophilus influenzaeHumansImmunologic FactorsInfantInfant, NewbornInflammatory Bowel DiseasesMalePregnancyPregnancy ComplicationsProspective StudiesAntibodies, BacterialImmunologic FactorsTetanus ToxinVaccinesImmunizationInfliximabNeonateRotavirus

Identifiers

PMID28870657
PMCPMC5735029
OpenAlexW2750588568

What OpenQuestion holds

Textmetadata
LicenceTDM
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.