BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Dorota Walkiewicz; Bożena Adamczyk; Michał Maluchnik; Jakub Perwieniec; Krzysztof Podwójcic; Mateusz Szeląg; Michał Zakrzewski; Konrad Rejdak; Agnieszka Słowik; Marcin Wnuk; Monika Adamczyk-Sowa Journal: J Clin Med Date: 2022-09-23 Impact factor: 4.964