Pregnancy Outcomes From an International Registry of Patients Treated With Delayed-release Dimethyl Fumarate

IntroductionClinical trials and post marketing reports show no safety signals with delayed-release dimethyl fumarate (DMF) exposure during pregnancy; however, these data are limited and the product label recommends use during pregnancy only if the potential benefit justifies the potential risk to the foetus. We assessed pregnancy outcomes in an ongoing international registry (NCT01911767) of women with MS exposed to DMF since the first day of their last menstrual period prior to conception or at any time during pregnancy.MethodsDMF-exposed women were prospectively evaluated for live births and pregnancy loss. Ectopic and molar pregnancies, birth defects, congenital anomalies or infant death occurring at ≤52 weeks of age, and maternal death at ≤12 weeks post-delivery, were reported. Data were collected at baseline (enrolment), 6–7 months of gestation, 4 weeks after the estimated delivery date, and 4, 12, and 52 weeks after birth. Potential birth defects were adjudicated by an external expert.ResultsAs of 30, Sept 2016 104 patients were enrolled in the registry; mean (SD) age was 315 years. DMF exposure occurred in the first (95%), second (1%), and third (0%) trimester in the 94 patients with a known exposure date. To date, 58 pregnancy outcomes have been reported, including 52 patients with 54 live births and 4 (7%) spontaneous abortions (<22 weeks). Of the 54 (93%) live births, 47 (87%) were full term (delivered ≥37 weeks) and four (7%) premature. Two (4%) infants had adjudicator-confirmed birth defects; one with pyloric stenosis, and one with transposition of the great vessels/patent ductus arteriosus. No maternal, neonatal, perinatal, or infant deaths were reported.ConclusionThe results from this ongoing registry did not identify a safety signal for DMF exposure on pregnancy outcomes, are consistent with previous reports, and provide essential information concerning exposure to DMF during pregnancy.

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Pregnancy Outcomes with Delayed-release Dimethyl Fumarate: Interim Results from an International Registry

10.26226/morressier.59a3e8b7d462b8028d89569e ◽

2017 ◽

Author(s):

Nicholas J. Everage

Keyword(s):

Pregnancy Outcomes ◽

Dimethyl Fumarate ◽

Delayed Release ◽

International Registry

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

Neurology and Therapy ◽

10.1007/s40120-015-0033-1 ◽

2015 ◽

Vol 4 (2) ◽

pp. 93-104 ◽

Cited By ~ 39

Author(s):

Ralf Gold ◽

J. Theodore Phillips ◽

Eva Havrdova ◽

Amit Bar-Or ◽

Ludwig Kappos ◽

...

Keyword(s):

Clinical Trials ◽

Pregnancy Outcomes ◽

Dimethyl Fumarate ◽

Preclinical Studies ◽

Delayed Release

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

Neurology Neuroimmunology & Neuroinflammation ◽

10.1212/nxi.0000000000001114 ◽

2021 ◽

Vol 9 (1) ◽

pp. e1114

Author(s):

Kerstin Hellwig ◽

David Rog ◽

Christopher McGuigan ◽

Maria K. Houtchens ◽

Denise R. Bruen ◽

...

Keyword(s):

Birth Defects ◽

Pregnancy Outcomes ◽

Interim Analysis ◽

Dimethyl Fumarate ◽

Trial Registration ◽

Clinical Trial Registration ◽

Live Births ◽

Link Type ◽

International Registry ◽

Adverse Pregnancy

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.DiscussionInterim 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 InformationTecGistry; clinical trial registration number: NCT01911767.

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