Available data from clinical trials and post-marketing reports show no safety signals with delayed-release dimethyl fumarate (DMF) exposure during pregnancy.
To assess pregnancy outcomes in an ongoing international registry of women with multiple sclerosis exposed to DMF.
Patients and methods
In this interim analysis, DMF-exposed women were prospectively evaluated for live births and pregnancy loss. Potential birth defects were adjudicated by an external expert. Gestational size was classified as small (<10th percentile), appropriate (10th–90th), or large (>90th) based on WHO or country-specific growth charts.
As of 15 December 2017, 132 pregnancy outcomes have been reported, including 126 (95%) live births and 6 (5%) spontaneous abortions (<22 weeks). Of the 126 live births, 115 (91%) were full term (delivered≥37 weeks), 8 (6%) premature and 3 (2%) missing data at birth. Four (3%) infants had adjudicator-confirmed birth defects: 1 with pyloric stenosis; 1 with transposition of the great vessels; and 2 infants had ventricular septal defect.
No ectopic or molar pregnancies were reported. No maternal, neonatal, perinatal, infant deaths or still births were reported. Of the 105 infants with gestational size data, 9 (9%) were classified as small, 87 (83%) as appropriate, and 9 (9%) as large and median (min, max) gestational weight was 3300 (1450, 4660) grams.
Consistent with previous reports, there was no safety signal for DMF exposure on pregnancy outcomes based on data from this ongoing registry.Le texte complet de cet article est disponible en PDF.
Keywords : Grossesse, Registre, dimethyl fumarate (DMF)