Evidence map›Paper›PMID 26000229›Full record

ArticleNeurology and therapy2014

Pregnancy outcomes following maternal and paternal exposure to teriflunomide during treatment for relapsing-remitting multiple sclerosis.

Bernd C Kieseier, Myriam Benamor

Abstract read
In one paragraph

Article in Neurology and therapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 1 pooled it
–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

46 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  6. Treatment and Relapse Prevention of Typical and Atypical Optic Neuritis.International journal of molecular sciences · 2022
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  11. What Can We Learn from Sex Differences in MS?Journal of personalized medicine · 2021
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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

2 authors.

Bernd C KieseierDepartment of Neurology, Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany.
Myriam BenamorGlobal Pharmacovigilance and Epidemiology, Sanofi R&D, Chilly-Mazarin, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTeriflunomide, indicated for the treatment of relapsing-remitting multiple sclerosis, is contraindicated in pregnancy based on signs of developmental toxicity in the offspring of rats and rabbits; developmental toxicity has also been observed in preclinical studies of other disease-modifying therapies. Despite the requirement to use reliable contraception in clinical trials evaluating the safety and efficacy of teriflunomide, a number of pregnancies have been reported. This work reports pregnancy outcomes in teriflunomide clinical trials.

methodsPregnancy outcomes were evaluated in a retrospective analysis of the global pharmacovigilance database. The following information was collected from the pharmacovigilance database or individual patient files: treatment allocation, pregnancy outcome, teriflunomide exposure, and use of the accelerated elimination procedure.

resultsAt data cut-off, 83 pregnancies were reported in female patients and 22 pregnancies were documented in partners of male patients. All newborns were healthy and did not have any structural or functional abnormalities at birth.

conclusionAvailable data do not indicate any teratogenic signals in patients treated with teriflunomide.

Indexed as

Clinical trialsMultiple sclerosisPregnancyTeratogenicityTeriflunomide

Identifiers

PMID26000229
PMCPMC4386431

What OpenQuestion holds

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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.