Evidence map›Paper›PMID 35362346›Full record

ArticleMultiple sclerosis (Houndmills, Basingstoke, England)2022

Eighteen-month safety analysis of offspring breastfed by mothers receiving glatiramer acetate therapy for relapsing multiple sclerosis - COBRA study.

Andrea Ines Ciplea, Anna Kurzeja, Sandra Thiel, Sabrina Haben, Jessica Alexander, Evelyn Adamus, Kerstin Hellwig

Open access · bronzeAbstract read
In one paragraph

Article in Multiple sclerosis (Houndmills, Basingstoke, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.8field-weighted citation impact, top 9% 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

11 citing papers in PubMed, 18 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

7 authors at 3 institutions in 3 countries.

Andrea Ines CipleaDepartment of Neurology, St. Josef Hospital - Katholisches Klinikum Bochum, Ruhr University Bochum, Bochum, Germany.
Anna KurzejaEuropean Medical Affairs, Teva Pharmaceuticals Europe B.V., Amsterdam, The Netherlands.
Sandra ThielDepartment of Neurology, St. Josef Hospital - Katholisches Klinikum Bochum, Ruhr University Bochum, Bochum, Germany.
Sabrina HabenDepartment of Neurology, St. Josef Hospital - Katholisches Klinikum Bochum, Ruhr University Bochum, Bochum, Germany.
Jessica AlexanderTeva Pharmaceutical Industries Ltd, West Chester, PA, USA.
Evelyn AdamusDepartment of Neurology, St. Josef Hospital - Katholisches Klinikum Bochum, Ruhr University Bochum, Bochum, Germany.
Kerstin HellwigDepartment of Neurology, St. Josef Hospital - Katholisches Klinikum Bochum, Ruhr University Bochum, Bochum, Germany.ORCID 0000-0003-4467-9011
St. Josef-Hospital · DETeva Pharmaceuticals (Netherlands) · NLTeva Pharmaceuticals (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSafety data on disease-modifying therapies (DMTs) for relapsing multiple sclerosis (RMS) during breastfeeding are limited.

objectiveAssess safety outcomes for offspring breastfed by mothers undergoing glatiramer acetate (GA; Copaxone

methodsThis non-interventional, retrospective study used German Multiple Sclerosis and Pregnancy Registry data. Participants had RMS, a live birth, and received GA or no DMT during breastfeeding.

resultsGA cohort: 58 mothers/60 offspring; matched controls: 60 mothers/60 offspring; 86.7% (GA) and 25% (control) of offspring were born to mothers who had GA at some point during pregnancy. Maternal demographics and disease activity were comparable. Annualized number of hospitalizations was similar for breastfed offspring: 0.20 (95% confidence interval: 0.09-0.31; GA) and 0.25 (0.12-0.38, controls). Proportion of offspring requiring hospitalization was comparable between cohorts (18.33% vs. 20.00%). Annualized number of antibiotic uses was similar in both cohorts (0.22, 0.10-0.33 (GA) vs. 0.17, 0.06-0.27 (controls)) The proportion of offspring requiring antibiotics was 15.00% (both cohorts). More developmental delays were identified in controls versus the GA cohort (3 (5.36%) vs. 0). Growth parameters were comparable between cohorts.

conclusionMaternal intake of GA during breastfeeding did not adversely affect offspring safety outcomes assessed during the first 18 months of life.

Indexed as

Glatiramer AcetateImmunosuppressive AgentsMultiple Sclerosis, Relapsing-RemittingBreast FeedingFemaleHumansInfantMaternal ExposurePregnancyRecurrenceRetrospective StudiesGlatiramer AcetateImmunosuppressive Agentsbreastfeedingdisease-modifying therapiesglatiramer acetateoffspring safetypregnancyRelapsing–remitting multiple sclerosis

Identifiers

PMID35362346
PMCPMC9315183
OpenAlexW4220795164

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.