Evidence map›Paper›PMID 39008024›Full record

ArticleDrug safety2024

Pregnancy Outcomes in Patients Treated with Upadacitinib: Analysis of Data from Clinical Trials and Postmarketing Reports.

Uma Mahadevan, Gweneth Levy, Lianne Gensler, Mira Ali, Ana P Lacerda, Lani Wegrzyn, Hannah Palac, Tina Bhutani-Jacques, Millie Long, Megan E B Clowse and 3 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Drug safety, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
–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

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
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  4. Update on Pregnancy in Inflammatory Bowel Disease.Gastroenterology & hepatology · 2026
    Article
  5. Observational
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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

13 authors.

Uma MahadevanDivision of Gastroenterology and Hepatology, University of California San Francisco, 1701 Divisadero Street #120, San Francisco, CA, 94010, USA. Uma.mahadevan@ucsf.edu.ORCID http://orcid.org/0000-0002-3067-8061
Gweneth LevyAbbVie, Inc., Chicago, IL, USA.
Lianne GenslerDivision of Rheumatology, University of California San Francisco, San Francisco, CA, USA.
Mira AliAbbVie, Inc., Chicago, IL, USA.
Ana P LacerdaAbbVie, Inc., Chicago, IL, USA.
Lani WegrzynAbbVie, Inc., Chicago, IL, USA.
Hannah PalacAbbVie, Inc., Chicago, IL, USA.
Tina Bhutani-JacquesDivision of Rheumatology, University of California San Francisco, San Francisco, CA, USA.
Millie LongUniversity of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Megan E B ClowseDivision of Rheumatology and Immunology, Duke University, Durham, NC, USA.
Alexa B KimballBeth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Christina ChambersDepartment of Pediatrics, University of California, San Diego, La Jolla, CA, USA.
Anthony R ScialliScialli Consulting LLC, Washington, DC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveUpadacitinib is indicated for diseases affecting persons of childbearing potential including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, Crohn's disease, and ulcerative colitis; however, teratogenicity was observed in animal studies. Given the potential for human fetal risk, pregnancy avoidance measures were required during clinical trials. This analysis describes pregnancy outcomes in patients exposed to upadacitinib during pregnancy.

methodsClinical trial and postmarketing cases of in utero exposure to upadacitinib were identified in AbbVie's safety database through 25 April, 2023. Analysis of clinical trial cases and postmarketing reports are presented separately; prospective and retrospectively reported pregnancy outcomes are integrated for each. Descriptive rates are presented to summarize outcomes.

resultsThere were 128 maternal upadacitinib-exposed pregnancies with known outcomes identified; 80 and 48 pregnancies were reported in clinical trials and the postmarketing setting, respectively. In clinical trials (mean in utero exposure of 5 weeks, 3 days), live births (54%), spontaneous abortions (24%), elective terminations (21%), and ectopic pregnancy (1%) were reported. There was one report of a congenital malformation: a 35-week infant with an atrial septal defect. In postmarketing cases, live births (46%), spontaneous abortions (38%), elective terminations (15%), and ectopic pregnancy (2%) were reported.

conclusionsAs the data are limited for in utero exposure to upadacitinib, definitive conclusions cannot be drawn regarding the effect of upadacitinib on pregnancy outcomes. Rates of adverse pregnancy outcomes with upadacitinib exposure were comparable to rates observed in the general population or patients with autoimmune inflammatory diseases. To date, no apparent evidence of teratogenicity exists in the analyses of human pregnancies exposed to upadacitinib during the first trimester.

Indexed as

Heterocyclic Compounds, 3-RingPregnancy OutcomeProduct Surveillance, PostmarketingAbnormalities, Drug-InducedAdultClinical Trials as TopicFemaleHumansPregnancyPregnancy ComplicationsRetrospective StudiesYoung AdultHeterocyclic Compounds, 3-Ringupadacitinib

Identifiers

PMID39008024
PMCPMC11399166

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.