Evidence map›Paper›PMID 32201504›Full record

ArticleTherapeutic advances in neurological disorders2020

Pregnancy outcomes from the global pharmacovigilance database on interferon beta-1b exposure.

Kerstin Hellwig, Fernando Duarte Caron, Eva-Maria Wicklein, Aasia Bhatti, Alessandra Adamo

Abstract read
In one paragraph

Article in Therapeutic advances in neurological disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

13 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Clinical Features and Maternal-fetal Results of Pregnant Women in COVID-19 Times.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2021
    Review
  9. Treatment of Women with Multiple Sclerosis Planning Pregnancy.Current treatment options in neurology · 2021
    Review
  10. Review
  11. Article
  12. ISUOG Interim Guidance on coronavirus disease 2019 (COVID-19) during pregnancy and puerperium: information for healthcare professionals - an update.Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · 2020
    Article
  13. 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

5 authors.

Kerstin HellwigDepartment of Neurology, St. Joseph and St. Elisabeth Hospital, Ruhr University, Bleichstrasse 15, Bochum, 44787, Germany.ORCID https://orcid.org/0000-0003-4467-9011
Fernando Duarte CaronBayer, Whippany, NJ, USA.
Eva-Maria WickleinBayer AG, Berlin, Germany.
Aasia BhattiBayer, Whippany, NJ, USA.
Alessandra AdamoBayer AG, São Paulo, Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe goal of the present cohort study was to review outcomes of patients exposed to interferon beta-1b during pregnancy.

methodsPregnancy cases with exposure to interferon beta-1b reported to Bayer's pharmacovigilance (PV) database from worldwide sources from January 1995 through February 2018 were retrieved for evaluation. Only cases where pregnancy outcomes were unknown at the time of reporting (i.e. prospective cases) were included in the analysis of this retrospective cohort study.

resultsAs of February 2018, 2581 prospective pregnancies exposed to interferon beta-1b were retrieved from the database; 1348 pregnancies had documented outcomes. The majority of outcomes [1106 cases (82.0%)] were live births. Health status was known for 981 live births (no known health status for 125). Most of the prospective pregnancies with known outcomes corresponded to live births with no congenital anomalies [896 cases (91.3%)]. Spontaneous abortion occurred in 160 cases (11.9%). Congenital birth defects were observed in 14/981 live births with known health status [1.4%, 95% confidence interval (CI) 0.78-2.38]. No consistent pattern in the type of birth defect was identified. Rates of both spontaneous abortion and birth defects were not higher than the general population.

conclusionsThese PV data, the largest sample of interferon beta-1b-exposed patients reported to date, suggest no increase in risk of spontaneous abortion or congenital anomalies in women exposed during pregnancy.

Indexed as

incidence studiesmultiple sclerosisneonatalobservational study

Identifiers

PMID32201504
PMCPMC7066586

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.