title: Pregnancy and fetal outcomes after interferon-β exposure in multiple sclerosis.
abstract: OBJECTIVE
  To assess pregnancy and fetal outcomes after in utero exposure to interferon-β (IFNβ) in all pregnancies occurring in women with multiple sclerosis (MS) during the study period, with a specific focus on the risk of spontaneous abortion.
  
  
  METHODS
  In this cohort study, data were gathered through a standardized, semi-structured interview. Patients who discontinued IFNβ less than 4 weeks from conception (exposed) were compared with those who had discontinued the drug at least 4 weeks from conception or who were never treated (not exposed). Possible confounders were handled through multivariate analyses adjusted for propensity score (PS).
  
  
  RESULTS
  We collected data on 396 pregnancies in 388 women, 88 classified as exposed (mean exposure 4.6 ± 5.8 weeks). IFNβ exposure was not associated with an increased risk of spontaneous abortion (PS-adjusted odds ratio [OR] 1.08, 95% confidence interval [CI] 0.4 to 2.9, p = 0.88), although it was associated with both lower baby weight (PS-adjusted β -113.8, p < 0.0001) and length (PS-adjusted β -1.102, p < 0.0001). Proportion of spontaneous abortion in exposed patients fell within the range expected for the Italian population in the same period. IFNβ exposure (PS-adjusted OR 2.11, 95% CI 1.18 to 3.78, p = 0.012) and cesarean delivery were the only predictors of preterm delivery. In the exposed group, we did not observe any significant fetal complications, malformations, or developmental abnormalities over a median follow-up of 2.1 years.
  
  
  CONCLUSIONS
  Our findings point to the relative safety of IFNβ exposure times of up to 4 weeks and can assist neurologists facing therapeutic decisions in women with MS with a pregnancy plan.
authors.affiliation: Department of Neurology, University of Florence, Florence, Italy. mariapia.amato@unifi.it
authors.forename: M P
authors.initials: MP
authors.lastname: Amato
authors.forename: E
authors.initials: E
authors.lastname: Portaccio
authors.forename: A
authors.initials: A
authors.lastname: Ghezzi
authors.forename: B
authors.initials: B
authors.lastname: Hakiki
authors.forename: V
authors.initials: V
authors.lastname: Zipoli
authors.forename: V
authors.initials: V
authors.lastname: Martinelli
authors.forename: L
authors.initials: L
authors.lastname: Moiola
authors.forename: F
authors.initials: F
authors.lastname: Patti
authors.forename: L
authors.initials: L
authors.lastname: La Mantia
authors.forename: G L
authors.initials: GL
authors.lastname: Mancardi
authors.forename: C
authors.initials: C
authors.lastname: Solaro
authors.forename: M R
authors.initials: MR
authors.lastname: Tola
authors.forename: C
authors.initials: C
authors.lastname: Pozzilli
authors.forename: L
authors.initials: L
authors.lastname: De Giglio
authors.forename: R
authors.initials: R
authors.lastname: Totaro
authors.forename: A
authors.initials: A
authors.lastname: Lugaresi
authors.forename: V
authors.initials: V
authors.lastname: Di Tommaso
authors.forename: D
authors.initials: D
authors.lastname: Paolicelli
authors.forename: M G
authors.initials: MG
authors.lastname: Marrosu
authors.forename: G
authors.initials: G
authors.lastname: Comi
authors.forename: F
authors.initials: F
authors.lastname: Pellegrini
authors.forename: M
authors.initials: M
authors.lastname: Trojano
mesh_terms: D000022:Abortion, Spontaneous / Q000139:chemically induced* / Q000209:etiology / Q000503:physiopathology; D000328:Adult; D015331:Cohort Studies; D005260:Female; D005315:Fetal Diseases / Q000139:chemically induced / Q000175:diagnosis / Q000503:physiopathology; D020567:Fetal Weight / Q000187:drug effects; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D016899:Interferon-beta / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D009103:Multiple Sclerosis / Q000150:complications / Q000188:drug therapy*; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology; D011446:Prospective Studies
chemical_list: D016899:Interferon-beta