Evidence map›Paper›PMID 37737962›Full record

ArticleDrugs - real world outcomes2023

Analysis of Pregnancy Outcomes Following Exposure to Intramuscular Interferon Beta-1a: The AVONEX

Bianca Weinstock-Guttman, Amy Perrin Ross, Jonathan Planton, Kurt White, Avni Pandhi, Andres Greco, Achint Kumar, Nicholas Everage, Megan Vignos

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Drugs - real world outcomes, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00168714 (Avonex Pregnancy Exposure Registry), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 39% 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.

NCT00168714 completednot on this map

Avonex Pregnancy Exposure Registry

TypeobservationalSponsorBiogenRan2004 to 2011Enrolled329ConditionsPrenatal Exposure Delayed Effects, Multiple Sclerosis, PregnancyArmsBG9418 (interferon beta-1a)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

9 authors at 3 institutions in 1 country.

Bianca Weinstock-GuttmanJacobs School of Medicine and Biomedical Sciences, University of Buffalo, 1010 Main St, 2nd floor, Buffalo, NY, 14202, USA.
Amy Perrin RossLoyola University Chicago, Chicago, IL, USA.
Jonathan PlantonBiogen, Cambridge, MA, USA.
Kurt WhiteBiogen, Cambridge, MA, USA.
Avni PandhiBiogen, Cambridge, MA, USA.
Andres GrecoBiogen, Cambridge, MA, USA.
Achint KumarBiogen, Cambridge, MA, USA.
Nicholas EverageBiogen, Cambridge, MA, USA.
Megan VignosBiogen, Cambridge, MA, USA. megan.vignos@biogen.com.ORCID http://orcid.org/0000-0002-7755-2781
Biogen (United States) · USLoyola University Chicago · USUniversity at Buffalo, State University of New York · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesThere is a lack of well-controlled US studies of intramuscular (IM) interferon beta (IFNβ)-1a use in pregnant women with multiple sclerosis; however, in the European Medicines Agency region, IFNβ formulations may be considered during pregnancy if clinically needed based on data from European Union cohort registries. The AVONEX Pregnancy Exposure Registry was established to prospectively study the effects of IM IFNβ-1a on the risk of birth defects and spontaneous pregnancy loss in a US population.

methodsPregnant women with multiple sclerosis exposed to IM IFNβ-1a within ~ 1 week of conception or during the first trimester were included. Participants were followed until there was a pregnancy outcome, live-born infants were followed until age 8-12 weeks. Data were collected on IM IFNβ-1a exposure, demographics, patient characteristics, medical history, and pregnancy outcomes, including live births (with or without birth defect), spontaneous abortions/miscarriages and fetal death/stillbirth, elective abortions (with and without birth defect), and ectopic pregnancies. A population-based birth defect surveillance program, the Metropolitan Atlanta Congenital Defects Program (MACDP), served as the primary external control group for evaluating the risk of birth defects.

resultsThree-hundred and two patients with a median (range) age of 31.0 (16-48) years and a median (range) gestational age at the time of enrollment of 10.1 (4-39) weeks were evaluable. Most patients (n = 278/302; 92%) reported IM IFNβ-1a exposure in the week before conception and most (n = 293/302; 97%) discontinued treatment before the end of the first trimester. Of 306 pregnancy outcomes, there were 272 live births, 28 spontaneous abortions of 266 pregnancies enrolled before 22 weeks' gestation (rate 10.5%; 95% confidence interval 7.2-15.0), five elective abortions, and one stillbirth. There were 17 adjudicator-confirmed major birth defects of 272 live births (rate 6.3%; 95% confidence interval 3.8-10.0); the pattern of birth defects observed was not suggestive of a relationship to prenatal IM IFNβ-1a exposure.

conclusionsThis large US registry study suggests IM IFNβ-1a exposure during early pregnancy was not clinically associated with adverse pregnancy outcomes in women with multiple sclerosis. These findings help inform clinicians and patients in weighing the risks and benefits of IM IFNβ-1a use during pregnancy. CLINICAL

trial registrationClinicalTrials.gov: NCT00168714, 15 September, 2005.

Identifiers

PMID37737962
PMCPMC10730480
OpenAlexW4386944835

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.