Open Access Highly Accessed Research article

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

Marta Giannini1, Emilio Portaccio114, Angelo Ghezzi2, Bahia Hakiki114, Luisa Pastò1, Lorenzo Razzolini114, Elisa Piscolla1, Laura De Giglio3, Carlo Pozzilli3, Damiano Paolicelli4, Maria Trojano4, Maria Giovanna Marrosu5, Francesco Patti6, Loredana La Mantia7, Gianluigi Mancardi8, Claudio Solaro9, Rocco Totaro10, Maria Rosaria Tola11, Giovanna De Luca12, Alessandra Lugaresi12, Lucia Moiola13, Vittorio Martinelli13, Giancarlo Comi13 and Maria Pia Amato1*

Author Affiliations

1 Department of Neurology, University of Florence, Florence, Italy

2 Multiple Sclerosis Center, S Antonio Abate Hospital, Gallarate, Italy

3 Multiple Sclerosis Center, S Andrea Hospital, La Sapienza University, Rome, Italy

4 Department of Neurology, University of Bari, Bari, Italy

5 Multiple Sclerosis Centre Department of Neurology, University of Cagliari, Cagliari, Italy

6 Multiple Sclerosis Centre, University of Catania, Catania, Italy

7 MS Center, C Besta National Neurological Institute, Milan, Italy

8 Department of Neurology, University of Genova, Genova, Italy

9 Department of Neurology, ASL3 Genovese, Genova, Italy

10 Department of Neurology, University of L’Aquila, L’Aquila, Italy

11 Department of Neuroscience, University of Ferraral, Ferrara, Italy

12 Department of Neuroscience, University of Ferrara, Ferrara, Italy

13 Department of Neurology, Scientific Institute H. San Raffaele University of Milan, Milan, Italy

14 Don Carlo Gnocchi Foundation ONLUS

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BMC Neurology 2012, 12:124  doi:10.1186/1471-2377-12-124

Published: 22 October 2012

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.

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.

Keywords:
Glatiramer acetate; Multiple sclerosis; Pregnancy; Pregnancy outcome; In utero exposure