Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.
Acta Neurol Scand. 2011 Jun;123(6):430-3. doi: 10.1111/j.1600-0404.2010.01426.x. Epub 2010 Sep 16.
In current literature, no data on safety in pregnancy for new drugs in the treatment of multiple sclerosis (MS) like natalizumab (Tysabri®), a humanized monoclonal antibody against α4 integrins, are yet available. In the management of MS, natalizumab is the first monoclonal antibody approved to the market.
We describe the pregnancy and outcome in two women with MS using natalizumab. The first patient used it in the periconceptional period, and the second patient used it in both the periconceptional period and throughout gestation.
The antenatal course of the first patient was complicated by an exacerbation of MS. The second patient did not experience MS relapses during pregnancy, while still using natalizumab. The newborns did not show any abnormalities postnatal and at 6 weeks' follow-up.
This is the first detailed report on pregnancy and delivery of two babies after maternal treatment of MS with natalizumab. From the small number of cases on the usage of natalizumab during pregnancy in literature, we cannot conclude whether the use of natalizumab is safe, and long-term effects are not known. Further research is needed to establish the exact effects on pregnancy and intrauterine development as well as the long-term effects. Prenatal counseling with thorough explanation of the risks and careful decision making is advisable.
在当前的文献中，尚无关于治疗多发性硬化症（MS）的新型药物（如那他珠单抗，一种针对 α4 整合素的人源化单克隆抗体）在妊娠安全性方面的数据。那他珠单抗是首个获批用于治疗 MS 的单克隆抗体。
我们描述了两名使用那他珠单抗治疗 MS 的女性的妊娠和结局。第一位患者在围孕期使用该药，第二位患者在围孕期和整个孕期均使用该药。
第一位患者的产前病程因 MS 恶化而复杂化。第二位患者在怀孕期间未出现 MS 复发，同时仍在使用那他珠单抗。新生儿出生后和 6 周随访时均未出现任何异常。
这是第一篇关于两名婴儿在母亲使用那他珠单抗治疗 MS 后妊娠和分娩的详细报告。根据文献中关于妊娠期间使用那他珠单抗的少数病例，我们无法确定使用那他珠单抗是否安全，也不知道长期影响。需要进一步研究以确定其对妊娠和宫内发育的确切影响以及长期影响。建议进行产前咨询，充分说明风险，并谨慎做出决策。
