Pregnancy and fetal outcomes after Glatiramer Acetate exposure in patients with multiple sclerosis: a prospective observational multicentric study

• Main Authors: Giannini Marta, Portaccio Emilio, Ghezzi Angelo, Hakiki Bahia, Pastò Luisa, Razzolini Lorenzo, Piscolla Elisa, De Giglio Laura, Pozzilli Carlo, Paolicelli Damiano, Trojano Maria, Marrosu Maria, Patti Francesco, La Mantia Loredana, Mancardi Gianluigi, Solaro Claudio, Totaro Rocco, Tola Maria, De Luca Giovanna, Lugaresi Alessandra, Moiola Lucia, Martinelli Vittorio, Comi Giancarlo, Amato Maria
• Format: Article
• Language: English
• Published: BMC 2012-10-01
• Series: BMC Neurology
• Subjects: Glatiramer acetate; Multiple sclerosis; Pregnancy; Pregnancy outcome; In utero exposure
• Online Access: http://www.biomedcentral.com/1471-2377/12/124

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Materials and methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusions</p> <p>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.</p>