Evidence map›Paper›PMID 38124108›Full record

Observational studyJournal of neurology, neurosurgery, and psychiatry2024

Disease activity and neonatal outcomes after exposure to natalizumab throughout pregnancy.

Sandra Thiel, Nastassja Litvin, Sabrina Haben, Ralf Gold, Kerstin Hellwig

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Journal of neurology, neurosurgery, and psychiatry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
11.6field-weighted citation impact, top 1% 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

12 citing papers in PubMed, 20 citations in OpenAlex.

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  7. Impact of sex on multiple sclerosis therapy.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025
    Review
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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

5 authors at 1 institution in 1 country.

Sandra ThielUniversitätsklinik für Neurologie der Ruhr-Universität Bochum, Katholisches Klinikum Bochum Sankt Josef-Hospital, Bochum, Nordrhein-Westfalen, Germany Sandra.Thiel@ruhr-uni-bochum.de.ORCID 0000-0002-5113-8451
Nastassja LitvinUniversitätsklinik für Neurologie der Ruhr-Universität Bochum, Katholisches Klinikum Bochum Sankt Josef-Hospital, Bochum, Nordrhein-Westfalen, Germany.
Sabrina HabenUniversitätsklinik für Neurologie der Ruhr-Universität Bochum, Katholisches Klinikum Bochum Sankt Josef-Hospital, Bochum, Nordrhein-Westfalen, Germany.
Ralf GoldUniversitätsklinik für Neurologie der Ruhr-Universität Bochum, Katholisches Klinikum Bochum Sankt Josef-Hospital, Bochum, Nordrhein-Westfalen, Germany.
Kerstin HellwigUniversitätsklinik für Neurologie der Ruhr-Universität Bochum, Katholisches Klinikum Bochum Sankt Josef-Hospital, Bochum, Nordrhein-Westfalen, Germany.ORCID 0000-0003-4467-9011
Katholisches Klinikum Bochum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAfter natalizumab discontinuation severe relapses can occur despite pregnancy, but third trimester exposure is associated with neonatal haematological abnormalities (HA). The best time point for stopping natalizumab during pregnancy is unclear.

methodsProspective, observational cohort with 350 natalizumab exposed pregnancies from the German Multiple Sclerosis and Pregnancy Registry. Clinical disease activity and neonatal outcomes are compared between women with natalizumab discontinuation during (1st Trim-group) versus after the first trimester (maintaining-group) and for subgroup analysis before (<30-subgroup) or after (≥30-subgroup) the 30th gestational week (gw).

resultsBaseline characteristics did not significantly differ between the 1st Trim-group (n=179; median exposure duration: 2.60 gw, IQR 1.30-3.60) and the maintaining-group (n=171; median exposure duration: 30.9 gw, IQR 26.9-33.3). Fewer relapses occurred during pregnancy and the postpartum year in the maintaining-group (25.7%) compared with the 1st Trim-group (62.6%; p<0.001). Women in ≥30-subgroup had a significantly lower relapse risk in the first 6 months postpartum (relapse rate ratio: 0.36, 95% CI: 0.15 to 0.84). In total, 7.5% retained meaningful disability 12 months postpartum. No significant effect on neonatal outcomes were observed, but anaemia (OR: 2.62, 95% CI: 1.12 to 6.52) and thrombocytopaenia (OR: 2.64, 95% CI: 1.15 to 6.46) were significantly more common in the ≥30-subgroup. 21.8% of all neonates were born small for gestational age, independent of the timing of natalizumab discontinuation.

conclusionContinuing natalizumab during pregnancy after gw 30 decreases the relapse risk postpartum going along with a higher risk for HA in the newborns. These results add relevant knowledge as a basis for informed risk-benefit discussion.

Indexed as

NatalizumabAdultFemaleHumansImmunologic FactorsInfant, NewbornMultiple SclerosisMultiple Sclerosis, Relapsing-RemittingPregnancyPregnancy ComplicationsPregnancy OutcomeProspective StudiesRecurrenceRegistriesImmunologic FactorsNatalizumabMULTIPLE SCLEROSIS

Identifiers

PMID38124108
PMCPMC11103322
OpenAlexW4389981775

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.