TY - JOUR
T1 - Pregnancy and fetal outcomes after Glatiramer Acetate exposure in patients with multiple sclerosis
T2 - a prospective observational multicentric study
AU - Giannini, Marta
AU - Portaccio, Emilio
AU - Ghezzi, Angelo
AU - Hakiki, Bahia
AU - Pastò, Luisa
AU - Razzolini, Lorenzo
AU - Piscolla, Elisa
AU - De Giglio, Laura
AU - Pozzilli, Carlo
AU - Paolicelli, Damiano
AU - Trojano, Maria
AU - Marrosu, Maria G.
AU - Patti, Francesco
AU - La Mantia, Loredana
AU - Mancardi, Gianluigi
AU - Solaro, Claudio
AU - Totaro, Rocco
AU - Tola, Maria R.
AU - De Luca, Giovanna
AU - Lugaresi, Alessandra
AU - Moiola, Lucia
AU - Martinelli, Vittorio
AU - Comi, Giancarlo
AU - Amato, Maria P.
PY - 2012/10/22
Y1 - 2012/10/22
N2 - 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.Materials and 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.
AB - 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.Materials and 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.
KW - Glatiramer acetate
KW - In utero exposure
KW - Multiple sclerosis
KW - Pregnancy
KW - Pregnancy outcome
UR - http://www.scopus.com/inward/record.url?scp=84867657238&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84867657238&partnerID=8YFLogxK
U2 - 10.1186/1471-2377-12-124
DO - 10.1186/1471-2377-12-124
M3 - Article
C2 - 23088447
AN - SCOPUS:84867657238
SN - 1471-2377
VL - 12
JO - BMC Neurology
JF - BMC Neurology
M1 - 124
ER -