Evidence map›Paper›PMID 32983608›Full record

ArticleNeurology. Clinical practice2020

Teriflunomide-exposed pregnancies in a French cohort of patients with multiple sclerosis.

Astrid Barataud-Reilhac, Sandrine Kerbrat, Jonathan Roux, Alice Guilleux, Elisabeth Polard, Emmanuelle Leray

Open access · greenAbstract read
In one paragraph

Article in Neurology. Clinical practice, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.1field-weighted citation impact, top 21% 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

2 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Review
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

6 authors at 1 institution in 1 country.

Astrid Barataud-ReilhacEcole des Hautes Etudes en Santé Publique (EHESP) (AB-R, JR, AG, EL), Département METIS, F-35043 Rennes, France; Univ Rennes (SK, JR, AG, EP, EL), EHESP, REPERES (Recherche en pharmaco-épidémiologie et recours aux soins)-EA 7449, F-35000 Rennes, France; and Service de Pharmacovigilance (EP), CHU Rennes, F-35000 Rennes, France.
Sandrine KerbratEcole des Hautes Etudes en Santé Publique (EHESP) (AB-R, JR, AG, EL), Département METIS, F-35043 Rennes, France; Univ Rennes (SK, JR, AG, EP, EL), EHESP, REPERES (Recherche en pharmaco-épidémiologie et recours aux soins)-EA 7449, F-35000 Rennes, France; and Service de Pharmacovigilance (EP), CHU Rennes, F-35000 Rennes, France.
Jonathan RouxEcole des Hautes Etudes en Santé Publique (EHESP) (AB-R, JR, AG, EL), Département METIS, F-35043 Rennes, France; Univ Rennes (SK, JR, AG, EP, EL), EHESP, REPERES (Recherche en pharmaco-épidémiologie et recours aux soins)-EA 7449, F-35000 Rennes, France; and Service de Pharmacovigilance (EP), CHU Rennes, F-35000 Rennes, France.
Alice GuilleuxEcole des Hautes Etudes en Santé Publique (EHESP) (AB-R, JR, AG, EL), Département METIS, F-35043 Rennes, France; Univ Rennes (SK, JR, AG, EP, EL), EHESP, REPERES (Recherche en pharmaco-épidémiologie et recours aux soins)-EA 7449, F-35000 Rennes, France; and Service de Pharmacovigilance (EP), CHU Rennes, F-35000 Rennes, France.
Elisabeth PolardEcole des Hautes Etudes en Santé Publique (EHESP) (AB-R, JR, AG, EL), Département METIS, F-35043 Rennes, France; Univ Rennes (SK, JR, AG, EP, EL), EHESP, REPERES (Recherche en pharmaco-épidémiologie et recours aux soins)-EA 7449, F-35000 Rennes, France; and Service de Pharmacovigilance (EP), CHU Rennes, F-35000 Rennes, France.
Emmanuelle LerayEcole des Hautes Etudes en Santé Publique (EHESP) (AB-R, JR, AG, EL), Département METIS, F-35043 Rennes, France; Univ Rennes (SK, JR, AG, EP, EL), EHESP, REPERES (Recherche en pharmaco-épidémiologie et recours aux soins)-EA 7449, F-35000 Rennes, France; and Service de Pharmacovigilance (EP), CHU Rennes, F-35000 Rennes, France.
École des Hautes Études en Santé Publique · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo describe pregnancies exposed to teriflunomide (TERIF) in women with multiple sclerosis (MS) in France over the period 2014-2016.

methodsAll 15- to 49-year-old women with MS in the national health insurance database were included. Pregnancies that had started between August 2014 and March 2016 were identified from their outcomes. Three groups according to treatment exposure were compared: TERIF, interferons (IFNs) or glatiramer acetate, and no medication.

resultsAmong the 44,008 women with MS followed 24.5 months on average, 2,639 pregnancies were identified. There were 1,538 pregnancies (58.3%) that were not exposed to any MS treatment in accordance with the guidelines. A total of 673 pregnancies (25.5%) were exposed to IFN and/or glatiramer acetate, and possible or probable exposure to contra-indicated treatments was observed in 428 pregnancies (16.2%), of whom 47 pregnancies were exposed to TERIF. The annual incidence rate of pregnancies exposed to TERIF was 1.4 per 100 patient-years; i.e., 3 times less than the 2 control groups (5.6 and 4.7, respectively). The median exposure duration to TERIF was 45 days after conception. The outcomes comprised 23 live births, 22 abortions (3 times more than the 2 other groups), and 2 miscarriages. All newborns were healthy at birth.

conclusionsDespite specific TERIF guidelines for pregnancy-related issues and the availability of alternative therapies, some pregnancies exposed to TERIF were identified. Most of the cases were because of the absence of the recommended accelerated elimination procedure and appeared to be mostly unplanned pregnancies that probably reflect a lack of effective contraception.

Identifiers

PMID32983608
PMCPMC7508337
OpenAlexW2973783395

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.