Maternal and neonatal outcomes associated with natalizumab exposure during pregnancy in patients with multiple sclerosis

2025

Abstract

Introduction: The use of natalizumab (NTZ) raises concerns regarding its safety for both mothers and the fetus. However, there is a risk of rebound after rapid withdrawal of NTZ despite pregnancy. Herein, we aimed to describe our experience with pregnancy outcomes in mothers with multiple sclerosis (MS) who continued NTZ during pregnancy.

Material and methods: This prospective cohort study was conducted at the Sina MS Clinic (Tehran, Iran) from March 1, 2018, to March 30, 2023. Thirty patients with relapsing-remitting MS (RRMS) receiving NTZ during pregnancy were included. Maternal, neonatal, and disease-related outcomes were analyzed using SPSS version 26.0.

Results: Thirty pregnant women with a mean age of 30.10 ± 5.77 years and disease duration of 8.37 ± 3.60 years were assessed. Ninety percent of patients continued NTZ during the third trimester with a last NTZ exposure at the mean gestational age of 29.3 ± 5.05 weeks. No relapses occurred during pregnancy. One patient (3.33 %) relapsed postpartum, associated with earlier NTZ discontinuation (at 28th week of gestation) (P = 0.02). All pregnancies were successful, with 93.33 % being full-term with a mean gestational age at delivery of 37.79 ± 1.23 weeks. Five pregnancies (17.24 %) were associated with a low birth weight, which was marginally associated with continuous NTZ exposure after the 30th week (P = 0.052) and gestational age at the last exposure (P = 0.065). In terms of disease-modifying treatment (DMT) resumption, all patients started their DMT, of whom 66.7 % continued NTZ as their DMT. Further, 46.7 % of patients decided to have parallel breastfeeding.

Conclusion: In this cohort, continuing NTZ during pregnancy, including into the third trimester, appeared to be generally well tolerated and not associated with major maternal or neonatal complications. While only one postpartum relapse was observed, its occurrence in the context of earlier NTZ discontinuation highlights the potential risks of early withdrawal.

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