Evidence map›Paper›PMID 34815321›Full record

Trial reportNeurology(R) neuroimmunology & neuroinflammation2022

Interim Analysis of Pregnancy Outcomes After Exposure to Dimethyl Fumarate in a Prospective International Registry.

Kerstin Hellwig, David Rog, Christopher McGuigan, Maria K Houtchens, Denise R Bruen, Oksana Mokliatchouk, Filipe Branco, Xiaomei Peng, Nicholas J Everage

Registry-linked trialOpen access · goldAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology(R) neuroimmunology & neuroinflammation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01911767 (Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
5.7field-weighted citation impact, top 4% 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.

NCT01911767 completednot on this map

Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry

Typeobservational_patient_registrySponsorBiogenRan2013 to 2022Enrolled408ConditionsMultiple Sclerosis, Exposure During PregnancyArmsDimethyl fumarate, Peginterferon beta-1a
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 30 citations in OpenAlex.

  1. Article
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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

9 authors at 1 institution in 4 countries.

Kerstin HellwigFrom the Katholisches Klinikum Bochum (K.H.), Ruhr University, Germany; Manchester Centre for Clinical Neurosciences (D.R.), Salford Royal NHS Foundation Trust, United Kingdom; Department of Neurology (C.M.), St. Vincent's University Hospital & University College, Dublin, Ireland; Partners MS Center (M.K.H.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Adult Neurology Clinic (D.R.B.), Charlottesville, VA; and Biogen (O.M., F.B., X.P., N.J.E.), Cambridge, MA.ORCID 0000-0003-4467-9011
David RogFrom the Katholisches Klinikum Bochum (K.H.), Ruhr University, Germany; Manchester Centre for Clinical Neurosciences (D.R.), Salford Royal NHS Foundation Trust, United Kingdom; Department of Neurology (C.M.), St. Vincent's University Hospital & University College, Dublin, Ireland; Partners MS Center (M.K.H.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Adult Neurology Clinic (D.R.B.), Charlottesville, VA; and Biogen (O.M., F.B., X.P., N.J.E.), Cambridge, MA.ORCID 0000-0002-7262-4248
Christopher McGuiganFrom the Katholisches Klinikum Bochum (K.H.), Ruhr University, Germany; Manchester Centre for Clinical Neurosciences (D.R.), Salford Royal NHS Foundation Trust, United Kingdom; Department of Neurology (C.M.), St. Vincent's University Hospital & University College, Dublin, Ireland; Partners MS Center (M.K.H.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Adult Neurology Clinic (D.R.B.), Charlottesville, VA; and Biogen (O.M., F.B., X.P., N.J.E.), Cambridge, MA.
Maria K HoutchensFrom the Katholisches Klinikum Bochum (K.H.), Ruhr University, Germany; Manchester Centre for Clinical Neurosciences (D.R.), Salford Royal NHS Foundation Trust, United Kingdom; Department of Neurology (C.M.), St. Vincent's University Hospital & University College, Dublin, Ireland; Partners MS Center (M.K.H.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Adult Neurology Clinic (D.R.B.), Charlottesville, VA; and Biogen (O.M., F.B., X.P., N.J.E.), Cambridge, MA.ORCID 0000-0001-6077-0654
Denise R BruenFrom the Katholisches Klinikum Bochum (K.H.), Ruhr University, Germany; Manchester Centre for Clinical Neurosciences (D.R.), Salford Royal NHS Foundation Trust, United Kingdom; Department of Neurology (C.M.), St. Vincent's University Hospital & University College, Dublin, Ireland; Partners MS Center (M.K.H.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Adult Neurology Clinic (D.R.B.), Charlottesville, VA; and Biogen (O.M., F.B., X.P., N.J.E.), Cambridge, MA.
Oksana MokliatchoukFrom the Katholisches Klinikum Bochum (K.H.), Ruhr University, Germany; Manchester Centre for Clinical Neurosciences (D.R.), Salford Royal NHS Foundation Trust, United Kingdom; Department of Neurology (C.M.), St. Vincent's University Hospital & University College, Dublin, Ireland; Partners MS Center (M.K.H.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Adult Neurology Clinic (D.R.B.), Charlottesville, VA; and Biogen (O.M., F.B., X.P., N.J.E.), Cambridge, MA.
Filipe BrancoFrom the Katholisches Klinikum Bochum (K.H.), Ruhr University, Germany; Manchester Centre for Clinical Neurosciences (D.R.), Salford Royal NHS Foundation Trust, United Kingdom; Department of Neurology (C.M.), St. Vincent's University Hospital & University College, Dublin, Ireland; Partners MS Center (M.K.H.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Adult Neurology Clinic (D.R.B.), Charlottesville, VA; and Biogen (O.M., F.B., X.P., N.J.E.), Cambridge, MA.
Xiaomei PengFrom the Katholisches Klinikum Bochum (K.H.), Ruhr University, Germany; Manchester Centre for Clinical Neurosciences (D.R.), Salford Royal NHS Foundation Trust, United Kingdom; Department of Neurology (C.M.), St. Vincent's University Hospital & University College, Dublin, Ireland; Partners MS Center (M.K.H.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Adult Neurology Clinic (D.R.B.), Charlottesville, VA; and Biogen (O.M., F.B., X.P., N.J.E.), Cambridge, MA.ORCID 0000-0002-4488-9628
Nicholas J EverageFrom the Katholisches Klinikum Bochum (K.H.), Ruhr University, Germany; Manchester Centre for Clinical Neurosciences (D.R.), Salford Royal NHS Foundation Trust, United Kingdom; Department of Neurology (C.M.), St. Vincent's University Hospital & University College, Dublin, Ireland; Partners MS Center (M.K.H.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Adult Neurology Clinic (D.R.B.), Charlottesville, VA; and Biogen (O.M., F.B., X.P., N.J.E.), Cambridge, MA. nicholas.everage@biogen.com.
University College Dublin · IE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesOral delayed-release dimethyl fumarate (DMF) is not recommended during pregnancy and should only be used if the potential benefit justifies the potential fetal risk. Although DMF was well tolerated in clinical trials with consistent safety results in postmarketing surveillance, data are limited in pregnant women. The objective was to provide pregnancy outcomes and DMF exposure information from an interim analysis from a prospective, international registry (TecGistry; NCT01911767).

methodsWomen exposed to DMF from the first day of their last menstrual period before conception or during pregnancy were evaluated. Data were obtained at enrollment; 6-7 months' gestation; 4 weeks after estimated due date; and 4, 12, and 52 weeks after birth. Outcomes included live births, gestational size, pregnancy loss, birth defects, and infant or maternal death after delivery. Outcomes were analyzed cumulatively from October 30, 2013 (the start of TecGistry), to April 8, 2020.

resultsOf 345 enrolled patients, median (range) age was 32 (20-43) years. The mean (SD) duration of gestational weeks of DMF exposure was 4.9 (3.8). Most infants were full-term at birth (n = 249/274; 91%) and of average gestational size (n = 190/232; 82%). Of 351 outcomes, 277 were live births; 17 (5%) spontaneous abortions (95% confidence interval [CI] 2.6%-7.1%), including 1 (<1%) molar and 1 (<1%) ectopic pregnancy, were reported. There were 8 (2.9% [95% CI 1.3%-5.6%]) adjudicator-confirmed birth defects among the 277 live births. DISCUSSION: Interim results from this large registry indicate that early DMF exposure was not significantly associated with adverse pregnancy outcomes. Outcomes are consistent with previous smaller reports and with the general population. TRIAL REGISTRATION INFORMATION: TecGistry; clinical trial registration number: NCT01911767.

Indexed as

Pregnancy OutcomeRegistriesAdultDimethyl FumarateFemaleHumansImmunosuppressive AgentsPregnancyPregnancy ComplicationsProspective StudiesYoung AdultDimethyl FumarateImmunosuppressive Agents

Identifiers

PMID34815321
PMCPMC8611504
OpenAlexW3216659456

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Registered trials

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.