title: Birth outcomes in newborns fathered by men with multiple sclerosis exposed to disease-modifying drugs.
abstract: 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.
authors.affiliation: Brain Research Centre and Department of Medicine (Division of Neurology), Faculty of Medicine, University of British Columbia, Vancouver, Canada.
authors.forename: Ellen
authors.initials: E
authors.lastname: Lu
authors.forename: Feng
authors.initials: F
authors.lastname: Zhu
authors.forename: Yinshan
authors.initials: Y
authors.lastname: Zhao
authors.forename: Mia
authors.initials: M
authors.lastname: van der Kop
authors.forename: Anne
authors.initials: A
authors.lastname: Synnes
authors.forename: Leanne
authors.initials: L
authors.lastname: Dahlgren
authors.forename: A Dessa
authors.initials: AD
authors.lastname: Sadovnick
authors.forename: Anthony
authors.initials: A
authors.lastname: Traboulsee
authors.forename: Helen
authors.initials: H
authors.lastname: Tremlett
mesh_terms: D000328:Adult; D001724:Birth Weight; D001955:British Columbia; D016208:Databases, Factual; D005220:Fathers; D005260:Female; D005865:Gestational Age; D000068717:Glatiramer Acetate; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D007231:Infant, Newborn; D016899:Interferon-beta / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D015999:Multivariate Analysis; D018812:Paternal Exposure / Q000009:adverse effects; D010455:Peptides / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012042:Registries; D012189:Retrospective Studies; D055815:Young Adult
chemical_list: D007155:Immunologic Factors; D010455:Peptides; D000068717:Glatiramer Acetate; D016899:Interferon-beta