Evidence map›Paper›PMID 42426711›Full record

ArticleBMC pregnancy and childbirth2026

Use of multiple sclerosis drugs among pregnant individuals with live-birth deliveries in the FDA's Sentinel Distributed Database.

Danijela Stojanovic, Lockwood Taylor, Mayura Shinde, Nicole Haug, Mohamed Mohamoud, Leyla Sahin, Amanda Carruth, Rebecca Hawrusik, Jennifer G Lyons

Abstract read
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In one paragraph

Article in BMC pregnancy and childbirth, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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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

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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

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0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

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5 · Who and what money

Authors and funding

9 authors.

Danijela StojanovicU.S. Food and Drug Administration, Silver Spring, MD, USA.
Lockwood TaylorU.S. Food and Drug Administration, Silver Spring, MD, USA.
Mayura ShindeDepartment of Population Medicine, Harvard Medical School, Harvard Pilgrim Health Care Institute, 401 Park Drive, Boston, MA, USA.
Nicole HaugDepartment of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Mohamed MohamoudU.S. Food and Drug Administration, Silver Spring, MD, USA.
Leyla SahinU.S. Food and Drug Administration, Silver Spring, MD, USA.
Amanda CarruthDepartment of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Rebecca HawrusikDepartment of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Jennifer G LyonsDepartment of Population Medicine, Harvard Medical School, Harvard Pilgrim Health Care Institute, 401 Park Drive, Boston, MA, USA. Jennifer_lyons@populationmedicine.org.

Funding

FDA HHS HHSF223200910006IU.S. Food and Drug Administration HHSF223200910006I, HHSF22301007T
6 · The paper itself

Abstract

backgroundAdministrative claims databases may complement pregnancy registries for post-marketing utilization assessment and safety surveillance.

objectiveTo assess patterns of utilization of disease-modifying therapies (DMT) indicated for treatment of multiple sclerosis among women with live-birth deliveries across pregnancy and over time.

methodsWe conducted a retrospective administrative claims-based utilization analysis from January 1, 2001, to December 31, 2020 in the Sentinel Distributed Database. We described use across the pregnancy period and over time among pregnancies ending in a live-birth delivery and matched non-pregnant episodes.

resultsAmong 2,142,706 pregnancies resulting in live-birth deliveries, 1,362 pregnancies were exposed to DMTs (< 0.1%). Glatiramer acetate was the most prevalent DMT any time in pregnancy (48.9%), followed by interferon beta 1a (22.4%), dimethyl fumarate (10.7%), and natalizumab (8.4%). The highest use was observed six months prior to pregnancy start, while the lowest use was in the second trimester.

conclusionsIn our analysis, exposure to DMT was low and varied across the pregnancy period. Use among pregnant patients was highest in the six months prior to pregnancy start and remained lower than pre-pregnancy levels after delivery.

Indexed as

Multiple SclerosisPregnancy ComplicationsAdultDatabases, FactualDimethyl FumarateFemaleGlatiramer AcetateHumansInterferon beta-1aLive BirthNatalizumabPregnancyRetrospective StudiesUnited StatesUnited States Food and Drug AdministrationDimethyl FumarateGlatiramer AcetateInterferon beta-1aNatalizumabDMTPregnancyRWDUtilization

Identifiers

PMID42426711
PMCPMC13631975

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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.