Evidence map›Paper›PMID 39811788›Full record

ArticleThe Lancet regional health. Europe2025

Impact of disease-modifying therapies on pregnancy outcomes in multiple sclerosis: a prospective cohort study from the German multiple sclerosis and pregnancy registry.

Nadine Bast, Karen Dost-Kovalsky, Sabrina Haben, Natalia Friedmann, Laura Witt, Theresa Oganowski, Ralf Gold, Sandra Thiel, Kerstin Hellwig

Abstract read
In one paragraph

Article in The Lancet regional health. Europe, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–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

15 citing papers in PubMed.

  1. Article
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  3. Review
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  5. Article
  6. Review
  7. Article
  8. Review
  9. Observational
  10. Article
  11. Article
  12. Article
  13. Article
  14. Family planning and multiple sclerosis - Part 1: Patient perspectives on treatment choices in Sweden.Multiple sclerosis journal - experimental, translational and clinical
    Article
  15. 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.

Nadine BastDepartment of Neurology, St. Josef-Hospital - Katholisches Klinikum Bochum, Ruhr University Bochum, Gudrunstr. 56, 44791, Bochum, Germany.
Karen Dost-KovalskyDepartment of Neurology, St. Josef-Hospital - Katholisches Klinikum Bochum, Ruhr University Bochum, Gudrunstr. 56, 44791, Bochum, Germany.
Sabrina HabenDepartment of Neurology, St. Josef-Hospital - Katholisches Klinikum Bochum, Ruhr University Bochum, Gudrunstr. 56, 44791, Bochum, Germany.
Natalia FriedmannDepartment of Neurology, St. Josef-Hospital - Katholisches Klinikum Bochum, Ruhr University Bochum, Gudrunstr. 56, 44791, Bochum, Germany.
Laura WittDepartment of Neurology, St. Josef-Hospital - Katholisches Klinikum Bochum, Ruhr University Bochum, Gudrunstr. 56, 44791, Bochum, Germany.
Theresa OganowskiDepartment of Neurology, St. Josef-Hospital - Katholisches Klinikum Bochum, Ruhr University Bochum, Gudrunstr. 56, 44791, Bochum, Germany.
Ralf GoldDepartment of Neurology, St. Josef-Hospital - Katholisches Klinikum Bochum, Ruhr University Bochum, Gudrunstr. 56, 44791, Bochum, Germany.
Sandra ThielDepartment of Neurology, St. Josef-Hospital - Katholisches Klinikum Bochum, Ruhr University Bochum, Gudrunstr. 56, 44791, Bochum, Germany.
Kerstin HellwigDepartment of Neurology, St. Josef-Hospital - Katholisches Klinikum Bochum, Ruhr University Bochum, Gudrunstr. 56, 44791, Bochum, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: In recent decades, relapsing remitting multiple sclerosis (MS) became more treatable through new disease-modifying therapies (DMTs). Identifying safe treatments with minimal fetal risks for family planning is needed. Methods: In this prospective cohort from the German MS and Pregnancy Registry (DMSKW), we analyzed pregnancy and neonatal outcomes in MS-patients using descriptive statistics and logistic/linear regression models to compare DMT-exposed pregnancies to DMT-unexposed pregnancies. Findings: In 2885 DMT-exposed and 837 DMT-unexposed pregnancies, exposure was not associated with spontaneous abortions, preterm births or major congenital anomalies (MCAs). Severe infections were rare, but more frequent in the Fumarates-group (11/395: 2.8% vs. 8/837 unexposed-group: 1.0%, p-value: 0.03). Antibiotic-use was associated with 2nd-trimester (OR: 2.47, CI: 1.47, 4.05, p-value: <0.001), 3rd-trimester Natalizumab-exposure (OR: 1.75, CI: 1.15, 2.63, p-value: 0.01), and anti-CD20-exposure (OR: 2.16, CI: 1.41, 3.29, p-value: <0.001). Birthweight was significantly reduced in the Sphingosine-1-phosphate-group (β: -132 g, CI: -205, -60, p-value: <0.001), and 3rd-trimester Natalizumab-subgroup (β: -74 g, CI: -138, -9.4, p-value: 0.02). Small for gestational age (SGA) neonates were common in the Sphingosine-1-phospate- (OR: 1.65, CI: 1.07, 2.50, p-value: 0.02) and anti-CD20-group (OR: 1.54, CI: 1.01, 2.32, p-value: 0.04), and also the entire cohort (651/3459: 18.8%), exceeding the general German population rate (10%) (p-value: <0.001). Interpretation: We observed an increased SGA risk, especially following highly-effective DMTs, although the pathomechanisms remain unclear. More research is needed on infection risks and MCAs, perhaps by linking different registries. Funding: The DMSKW is partly supported by Almirall, Biogen, Hexal, Merck, Novartis, Roche, Sanofi Genzyme, Teva Pharma and Viatris.

Indexed as

Disease modifying therapiesMultiple sclerosisPregnancy outcomesPregnancy registryProspective cohort study

Identifiers

PMID39811788
PMCPMC11732200

What OpenQuestion holds

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LicenceCC BY-NC
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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.