Evidence map›Paper›PMID 23902720›Full record

SynthesisBMC medicine2013

Safety of TNF-α inhibitors during IBD pregnancy: a systematic review.

Ole Haagen Nielsen, Edward V Loftus, Tine Jess

Open access · goldAbstract readCase ReportsSystematic Review
In one paragraph

Synthesis in BMC medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
17.3field-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.

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

40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 135 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. Saudi consensus guidance for the management of inflammatory bowel disease during pregnancy.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2023
    Article
  7. Article
  8. Article
  9. Article
  10. Medical Treatment Options for Ulcerative Colitis.Clinics in colon and rectal surgery · 2022
    Review
  11. Review
  12. Immune function in newborns withFrontiers in pediatrics · 2022
    Article
  13. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2021
    Review
  14. The use and impact of monoclonal antibody biologics during pregnancy.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2021
    Review
  15. Review
  16. Observational
  17. Review
  18. Article
  19. Review
  20. Use of Biologic Therapy by Pregnant Women With Inflammatory Bowel Disease Does Not Affect Infant Response to Vaccines.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2018
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors at 3 institutions in 2 countries.

Ole Haagen NielsenDepartment of Gastroenterology, Medical Section, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark. ohn@dadlnet.dk
Edward V Loftus
Tine Jess
Herlev Hospital · DKMayo Clinic in Arizona · USStatens Serum Institut · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTumor necrosis factor (TNF)-α inhibitors are increasingly being used in inflammatory bowel disease (IBD). Because this chronic intestinal disorder often affects women of fertile age, it is essential to assess the effect of biologics on pregnancy outcome.

methodsWe performed a systematic review of the English-language literature to investigate if treatment with TNF-α blockers during pregnancy in women with IBD increases the risk of spontaneous abortions, preterm delivery, stillbirth, low birth weight, congenital malformations, or risk of infections in the offspring. Of 552 articles and abstracts reviewed, 58 articles or abstracts with unique content were identified and included in this systematic review. However, most presentations were case reports or case series supplied by a limited number of observational studies. No randomized controlled studies were available.

resultsTNF-α inhibitors do not seem to affect either outcome of pregnancy in mothers with IBD, or the outcome in the offspring (congenital malformations and immunosuppression). Further, recent data have not identified any increased risk of infections in the first year of life in the offspring of mothers who received biologics, even in combination with immunomodulators (thiopurines).

conclusionsFrom the present systematic review, no association was found between administration of TNF inhibitors for IBD during pregnancy and adverse pregnancy outcome or congenital abnormalities. Further, no increased relative risk of infections has been reported in the first year of life in offspring of mothers who received biologics. Biologics should be discontinued during pregnancy solely if the IBD is in remission using the same stopping criteria as for patients with IBD in general, as uncontrolled activity of IBD may expose the mother and child to a risk greater than those only potentially coming from the use of TNF-α inhibitors. In such cases, inoculation of the offspring with live vaccines is contraindicated until the biologic agent is no longer detectable in the child's circulation.

Indexed as

AnimalsAntibodies, Monoclonal, HumanizedFemaleHumansInflammatory Bowel DiseasesPregnancyPregnancy ComplicationsPregnancy OutcomePrenatal Exposure Delayed EffectsRandomized Controlled Trials as TopicTumor Necrosis Factor-alphaAntibodies, Monoclonal, HumanizedTumor Necrosis Factor-alpha

Identifiers

PMID23902720
PMCPMC3734216
OpenAlexW1980639584

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.