Epub: Giannini et al. Pregnancy and foetal outcomes after Glatiramer Acetate exposure in patients with multiple sclerosis: a prospective observational multicentric study. BMC Neurol. 2012 Oct 22;12(1):124.
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 MS, these investigators aimed to assess pregnancy and foetal outcomes after in utero exposure to GA, using the same dataset, with a specific focus on the risk of spontaneous abortion.
METHODS: They recruited MSers, prospectively followed-up in 21 Italian MS Centres, for whom a pregnancy was recorded in the period 2002--2008. MSers 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 MSers 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 their cohort show that mother's GA exposure is not associated with a higher frequency of spontaneous abortion, neither other negative pregnancy and foetal 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.
"More reassuring data on GA in pregnancy for woman planning to have children whilst on DMTs. Good data?"
"Does this justify Teva pricing GA at greater than $50,000 per annum in the US, where a large number of woman MSers are uninsured and will not be able to afford the drug? In comparison, GA costs around $8,000 per annum under the NHS and every woman who fulfils the Deparrtment of Health's criteria for treatment can have access to the drug. This is the difference between a two-tiered market driven healthcare system, i.e the United States, and socialist healthcare (NHS & Europe). Where would you rather be looked after if you had MS? This is the issue that underpins our current survey about DMTs being a basic right if you are eligible for them under national guidelines."
Labels: Glaterimer Acetate, pregnancy