Evidence map›Paper›PMID 35297004›Full record

ArticleDrug safety2022

Pregnancy, Fetal, and Infant Outcomes Following Maternal Exposure to Glatiramer Acetate During Pregnancy and Breastfeeding.

Sigal Kaplan, Mikhail Zeygarnik, Tal Stern

Abstract read
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In one paragraph

Article in Drug safety, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.2field-weighted citation impact, top 12% 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

8 citing papers in PubMed, 16 citations in OpenAlex.

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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

3 authors at 1 institution in 2 countries.

Sigal KaplanTeva Pharmaceutical Industries Ltd., 12 Hatrufa St, Netanya, Israel. Sigal.kaplan@teva.co.il.ORCID http://orcid.org/0000-0002-3352-8480
Mikhail ZeygarnikTeva Pharmaceutical Industries Ltd., Netanya, Israel.ORCID http://orcid.org/0000-0002-6742-943X
Tal SternTeva Pharmaceutical Industries Ltd., Netanya, Israel.
Teva Pharmaceuticals (Israel) · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPublished data support the safety of glatiramer acetate in patients with multiple sclerosis who are pregnant or breastfeeding, but long-term data are limited.

objectiveWe aimed to assess pregnancy, fetal, and infant outcomes following maternal exposure to glatiramer acetate.

methodsIn-utero glatiramer acetate-exposed postmarketing pregnancy reports from 2019 to 2021 were extracted from Teva's pharmacovigilance database. Pregnancy data acquired prior to knowledge of pregnancy outcome or detection of congenital malformation (prospective reports) were used to estimate pregnancy and infant outcome rates for glatiramer acetate 20- and 40-mg/mL exposure. A subgroup of cases completed follow-up questionnaires and were analyzed separately.

resultsProspective cases with 702 fetuses had known outcomes with 647 (92.2%) live births, 47 (6.7%) spontaneous abortions, 4 (0.6%) induced abortions, 2 (0.3%) ectopic pregnancies, and 2 (0.3%) fetal deaths. Rates of major congenital malformation (1.1%), preterm births (7.2%), and low/very low birth weight (4.8%), and parameters of growth were within background rates. No infant developmental delay was reported. Overall, pregnancy and infant outcomes were similar across glatiramer acetate doses.

conclusionsMaternal exposure to glatiramer acetate does not appear to be related to adverse pregnancy, fetal, or infant outcomes. These data further support the safety of both glatiramer acetate 20-mg/mL and 40-mg/mL treatments during pregnancy and breastfeeding.

Indexed as

Breast FeedingMaternal ExposureFemaleFetusGlatiramer AcetateHumansInfantInfant, NewbornPregnancyPregnancy OutcomeGlatiramer Acetate

Identifiers

PMID35297004
OpenAlexW4221110645

What OpenQuestion holds

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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.