Evidence map›Paper›PMID 26662361›Full record

ArticleNeurology and therapy2015

Delayed-Release Dimethyl Fumarate and Pregnancy: Preclinical Studies and Pregnancy Outcomes from Clinical Trials and Postmarketing Experience.

Ralf Gold, J Theodore Phillips, Eva Havrdova, Amit Bar-Or, Ludwig Kappos, Norman Kim, Tim Thullen, Patricia Valencia, Lauren Oliva, Mark Novas and 5 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neurology and therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed
10.2field-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

36 citing papers in PubMed, 99 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. Review
  20. 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

15 authors at 6 institutions in 5 countries.

Ralf GoldSt. Josef Hospital, Ruhr University, Bochum, Germany. ralf.gold@ruhr-uni-bochum.de.
J Theodore PhillipsMultiple Sclerosis Program, Baylor Institute for Immunology Research, Dallas, TX, USA.
Eva HavrdovaCharles University, Prague, Czech Republic.
Amit Bar-OrMontreal Neurological Institute and Hospital, McGill University, Montreal, QC, Canada.
Ludwig KapposUniversity Hospital, Basel Neurology, Basel, Switzerland.
Norman KimBiogen, Inc., Cambridge, MA, USA.
Tim ThullenBiogen, Inc., Cambridge, MA, USA.
Patricia ValenciaBiogen, Inc., Cambridge, MA, USA.
Lauren OlivaBiogen, Inc., Cambridge, MA, USA.
Mark NovasBiogen, Inc., Cambridge, MA, USA.
Jie LiBiogen, Inc., Cambridge, MA, USA.
Marianne T SweetserBiogen, Inc., Cambridge, MA, USA.
Nuwan KurukulasuriyaBiogen, Inc., Cambridge, MA, USA.
Vissia VigliettaBiogen, Inc., Cambridge, MA, USA.
Robert J FoxMellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA.
Biogen (United States) · USCharles University · CZCleveland Clinic · USMcGill University · CARuhr University Bochum · DEUniversity Hospital of Basel · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDelayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) is an oral agent for the treatment of relapsing forms of multiple sclerosis (MS). No formal studies of DMF were conducted in pregnant women, although pregnancies have occurred during clinical trials and in the postmarketing setting.

methodsPreclinical developmental and reproductive toxicology studies were performed with DMF in rats and rabbits. As of March 26, 2014, the DMF clinical development program included a total of 4132 subjects consisting of 2898 patients with MS, 320 psoriasis patients, 101 rheumatoid arthritis patients, and 813 healthy volunteers. Subjects were required to use reliable contraception and immediately discontinue treatment in the event of pregnancy.

resultsAnimal studies showed no evidence of impaired fertility or teratogenicity with DMF. Overall as of June 30, 2014, 63 pregnancies were reported in clinical trials. Outcomes are known for 39 of 42 subjects receiving DMF and include 26 live births (67%), three spontaneous abortions (8%), and 10 elective terminations (26%); follow-up is ongoing in 2 cases and one patient was lost to follow-up. The incidence of spontaneous abortion in subjects exposed to DMF was consistent with the expected rate of early pregnancy loss in the general population (12-22%). A total of 135 pregnancies were reported in the postmarketing setting (spontaneous and solicited reports). Outcomes are known for 30 cases and include 10 live births, 13 spontaneous abortions, and 5 elective terminations; follow-up is ongoing in 103 cases and 2 patients have been lost to follow-up.

conclusionAlthough data are limited and all known exposures have occurred in the first trimester, no increased risk of fetal abnormalities or adverse pregnancy outcomes associated with gestational exposure to DMF has been observed.

fundingBiogen, Inc.

Indexed as

Clinical trialDelayed-release dimethyl fumarateMultiple sclerosisPostmarketingPreclinicalPregnancySafetyWomen

Identifiers

PMID26662361
PMCPMC4685863
OpenAlexW2168919398

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.