title: Pregnancy and fetal outcomes after Glatiramer Acetate exposure in patients with multiple sclerosis: a prospective observational multicentric study.
abstract: BACKGROUND
  Only few studies have assessed safety of in utero exposure to glatiramer acetate (GA). Following a previous study assessing the safety of interferon beta (IFNB) pregnancy exposure in multiple sclerosis (MS), we aimed to assess pregnancy and fetal outcomes after in utero exposure to GA, using the same dataset, with a specific focus on the risk of spontaneous abortion.
  
  
  METHODS
  We recruited MS patients, prospectively followed-up in 21 Italian MS Centres, for whom a pregnancy was recorded in the period 2002-2008. Patients were divided into 2 groups: drug-exposed pregnancies (EP: suspension of the drug less than 4 weeks from conception); non-exposed pregnancies (NEP: suspension of the drug at least 4 weeks from conception or never treated pregnancies). All the patients were administered a structured interview which gathered detailed information on pregnancy course and outcomes, as well as on possible confounders. Multivariate logistic and linear models were used for treatment comparisons.
  
  
  RESULTS
  Data on 423 pregnancies were collected, 17 were classified as EP to GA, 88 as EP to IFNB, 318 as NEP. Pregnancies resulted in 16 live births in the GA EP, 75 live births in the IFNB EP, 295 live births in the NEP. GA exposure was not significantly associated with an increased risk of spontaneous abortion (OR = 0.44;95% CI 0.044-4.51;p = 0.49). Mean birth weight and length were not significantly different in pregnancies exposed to GA than in non exposed pregnancies (p = 0.751). The frequency of preterm delivery, observed in 4 subjects exposed to GA (25% of full term deliveries), was not significantly higher in pregnancies exposed to GA than in those non exposed (p > 0.735). These findings were confirmed in the multivariate analysis. There were neither major complications nor malformations after GA exposure.
  
  
  CONCLUSIONS
  Data in our cohort show that mother's GA exposure is not associated with a higher frequency of spontaneous abortion, neither other negative pregnancy and fetal outcomes. Our findings point to the safety of in utero GA exposure and can support neurologists in the therapeutic counselling of MS women planning a pregnancy.
authors.affiliation: Department of Neurology, University of Florence, Florence, Italy.
authors.forename: Marta
authors.initials: M
authors.lastname: Giannini
authors.forename: Emilio
authors.initials: E
authors.lastname: Portaccio
authors.forename: Angelo
authors.initials: A
authors.lastname: Ghezzi
authors.forename: Bahia
authors.initials: B
authors.lastname: Hakiki
authors.forename: Luisa
authors.initials: L
authors.lastname: Pastò
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Razzolini
authors.forename: Elisa
authors.initials: E
authors.lastname: Piscolla
authors.forename: Laura
authors.initials: L
authors.lastname: De Giglio
authors.forename: Carlo
authors.initials: C
authors.lastname: Pozzilli
authors.forename: Damiano
authors.initials: D
authors.lastname: Paolicelli
authors.forename: Maria
authors.initials: M
authors.lastname: Trojano
authors.forename: Maria Giovanna
authors.initials: MG
authors.lastname: Marrosu
authors.forename: Francesco
authors.initials: F
authors.lastname: Patti
authors.forename: Loredana
authors.initials: L
authors.lastname: La Mantia
authors.forename: Gianluigi
authors.initials: G
authors.lastname: Mancardi
authors.forename: Claudio
authors.initials: C
authors.lastname: Solaro
authors.forename: Rocco
authors.initials: R
authors.lastname: Totaro
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: Tola
authors.forename: Giovanna
authors.initials: G
authors.lastname: De Luca
authors.forename: Alessandra
authors.initials: A
authors.lastname: Lugaresi
authors.forename: Lucia
authors.initials: L
authors.lastname: Moiola
authors.forename: Vittorio
authors.initials: V
authors.lastname: Martinelli
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Comi
authors.forename: Maria Pia
authors.initials: MP
authors.lastname: Amato
mesh_terms: D000328:Adult; D015897:Comorbidity; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D000068717:Glatiramer Acetate; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D008297:Male; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000453:epidemiology*; D010455:Peptides / Q000627:therapeutic use*; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology*; D011297:Prenatal Exposure Delayed Effects / Q000453:epidemiology*; D018570:Risk Assessment; D016896:Treatment Outcome
chemical_list: D010455:Peptides; D000068717:Glatiramer Acetate