Published in:
01-05-2014 | Original Research Article
Birth Outcomes in Newborns Fathered by Men with Multiple Sclerosis Exposed to Disease-Modifying Drugs
Published in: CNS Drugs | Issue 5/2014
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Objective
The aim of this study was to determine the incidence of births fathered by men with multiple sclerosis (MS) exposed to a disease-modifying drug (DMD) around the time of conception, and investigate the association between DMD exposure and birth outcomes in newborns of exposed and unexposed MS fathers.
Methods
Population-based databases in British Columbia (BC), Canada, (the BCMS database, Vital Statistics Birth Registry, Population Data BC Consolidation File/Census GeoData, BC PharmaNet and the BC Perinatal Database Registry) were linked in this retrospective cohort study (1996 to 2010). Multivariate models were used to examine the association between interferon-beta (IFNβ) or glatiramer acetate (GA) exposure (within 64 days prior to or at conception; i.e., the duration of spermatogenesis) with birth weight and gestational age of newborns.
Results
Of 195 births fathered by men with relapsing-onset MS, 80 births (41 %) were to fathers treated with a DMD before their child was born, with 53/195 (27 %) exposed within 64 days prior to or at the time of conception. Of the 53 exposed births, 37 were to IFNβ and 16 to GA. Mean birth weight of IFNβ-exposed and GA-exposed newborns was similar to that of unexposed newborns (adjusted difference: −107 g for both, p > 0.3). IFNβ-exposed and GA-exposed newborns also had comparable mean gestational ages relative to unexposed newborns (adjusted difference: −0.5 and −0.3 weeks, respectively, p > 0.2).
Conclusions
About one in three would-be fathers with MS were exposed to IFNβ or GA around the time of conception; there was no compelling evidence to suggest that exposure was associated with either lower birth weight or gestational age.