title: Final results from the Betaseron (interferon β-1b) Pregnancy Registry: a prospective observational study of birth defects and pregnancy-related adverse events.
abstract: OBJECTIVE
  Women with multiple sclerosis are often diagnosed and treated during their reproductive years. Limited data are available on the safety of treatment during pregnancy. The Betaseron Pregnancy Registry prospectively monitored women exposed to interferon β-1b (IFNβ-1b) during pregnancy to estimate the rates of birth defects, spontaneous abortions (SABs) and other negative outcomes in this population.
  
  
  METHODS
  From 2006 to 2011, this observational registry enrolled women exposed prior to conception or during pregnancy (but prior to or without abnormalities on prenatal screening). Follow-up continued from enrolment through the 4-month paediatric visit.
  
  
  METHODS
  Patients in the USA who met these criteria were enrolled in the registry.
  
  
  RESULTS
  The registry enrolled 99 pregnant women; 3 were lost to follow-up. The earliest exposure to IFNβ-1b occurred during the first trimester for 95 pregnancies and in the third trimester for 1 pregnancy. There were 99 birth outcomes (3 twins), including 86 (86.9%) live births, 11 (11.1%) SABs and 2 (2%) stillbirths. Birth defects were reported in five (5.1%) cases. Rates of birth defects and SAB were not significantly different from population comparators. No developmental concerns were identified at the 4-month paediatric visit.
  
  
  CONCLUSIONS
  The small sample size limits the ability to draw definitive conclusions; however, there was no pattern to suggest increased negative outcomes with IFNβ-1b.
  
  
  BACKGROUND
  NCT00317564.
authors.affiliation: Department of Neurology, Stony Brook University and MS Comprehensive Care Center, Stony Brook, New York, USA.
authors.forename: P K
authors.initials: PK
authors.lastname: Coyle
authors.forename: S M
authors.initials: SM
authors.lastname: Sinclair
authors.forename: A E
authors.initials: AE
authors.lastname: Scheuerle
authors.forename: J M
authors.initials: JM
authors.lastname: Thorp
authors.forename: J D
authors.initials: JD
authors.lastname: Albano
authors.forename: M J
authors.initials: MJ
authors.lastname: Rametta
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D000276:Adjuvants, Immunologic / Q000009:adverse effects*; D000328:Adult; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D000068576:Interferon beta-1b / Q000009:adverse effects*; D008297:Male; D011247:Pregnancy; D011248:Pregnancy Complications / Q000139:chemically induced* / Q000453:epidemiology*; D011446:Prospective Studies; D012042:Registries; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000068576:Interferon beta-1b
keywords: congenital abnormalities; interferon beta-1b; pediatrics; pregnancy