Long-term safety evaluation of natalizumab during pregnancy and lactation in patients with multiple sclerosis.

IF 2.4 4区 医学 Q2 CLINICAL NEUROLOGY
Neurological Sciences Pub Date : 2025-08-01 Epub Date: 2025-05-07 DOI:10.1007/s10072-025-08188-6
Giannicola Carrozzo, Federica Pinardi, Alessandra Lugaresi
{"title":"Long-term safety evaluation of natalizumab during pregnancy and lactation in patients with multiple sclerosis.","authors":"Giannicola Carrozzo, Federica Pinardi, Alessandra Lugaresi","doi":"10.1007/s10072-025-08188-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Natalizumab (NTZ) is a monoclonal antibody used in treating relapsing forms of multiple sclerosis (MS). However, there is still insufficient information about its long-term safety during pregnancy and lactation. This study aims to provide further insights into the short- and long-term effects of NTZ on mothers with MS and their children exposed to the drug during pregnancy and breastfeeding.</p><p><strong>Materials and methods: </strong>We recruited prospectively and retrospectively 14 women with MS, treated with NTZ, and their 15 children. All women continued NTZ treatment throughout pregnancy, and 10 of them also during breastfeeding. The follow-up period ranged from 1 to 5 years post-delivery, in the group exposed to NTZ both during pregnancy and breastfeeding; from 2 to 10 years post-delivery in the group exposed to NTZ exclusively during pregnancy.</p><p><strong>Results: </strong>During pregnancy, no relapses were reported, suggesting persistent efficacy of NTZ therapy. However, 1 out of 14 mothers experienced postpartum clinical events, without concomitant MRI activity MRI findings, and 2 other patients presented an isolated increase in lesion load, on MRI performed within 1 month after delivery, without clinical relapses. Neonatal outcomes were favorable, with normal birth parameters and absence of infections or developmental delays, with no differences between those exposed or not to NTZ during breastfeeding.</p><p><strong>Conclusions: </strong>NTZ therapy during pregnancy and breastfeeding is associated with favorable maternal and neonatal outcomes up to 10 years follow-up.</p>","PeriodicalId":19191,"journal":{"name":"Neurological Sciences","volume":" ","pages":"3797-3802"},"PeriodicalIF":2.4000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Neurological Sciences","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10072-025-08188-6","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/5/7 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Natalizumab (NTZ) is a monoclonal antibody used in treating relapsing forms of multiple sclerosis (MS). However, there is still insufficient information about its long-term safety during pregnancy and lactation. This study aims to provide further insights into the short- and long-term effects of NTZ on mothers with MS and their children exposed to the drug during pregnancy and breastfeeding.

Materials and methods: We recruited prospectively and retrospectively 14 women with MS, treated with NTZ, and their 15 children. All women continued NTZ treatment throughout pregnancy, and 10 of them also during breastfeeding. The follow-up period ranged from 1 to 5 years post-delivery, in the group exposed to NTZ both during pregnancy and breastfeeding; from 2 to 10 years post-delivery in the group exposed to NTZ exclusively during pregnancy.

Results: During pregnancy, no relapses were reported, suggesting persistent efficacy of NTZ therapy. However, 1 out of 14 mothers experienced postpartum clinical events, without concomitant MRI activity MRI findings, and 2 other patients presented an isolated increase in lesion load, on MRI performed within 1 month after delivery, without clinical relapses. Neonatal outcomes were favorable, with normal birth parameters and absence of infections or developmental delays, with no differences between those exposed or not to NTZ during breastfeeding.

Conclusions: NTZ therapy during pregnancy and breastfeeding is associated with favorable maternal and neonatal outcomes up to 10 years follow-up.

natalizumab在多发性硬化症患者妊娠和哺乳期的长期安全性评价。
背景:Natalizumab (NTZ)是一种用于治疗复发型多发性硬化症(MS)的单克隆抗体。然而,关于其在妊娠和哺乳期的长期安全性的信息仍然不足。本研究旨在进一步了解NTZ对MS母亲及其在怀孕和哺乳期间暴露于该药的孩子的短期和长期影响。材料和方法:我们前瞻性和回顾性地招募了14名接受NTZ治疗的MS妇女及其15名子女。所有妇女在整个怀孕期间继续接受NTZ治疗,其中10名妇女在哺乳期间也继续接受NTZ治疗。在怀孕和哺乳期间均暴露于NTZ的组中,随访期为分娩后1至5年;在怀孕期间完全暴露于NTZ的组中,在分娩后2至10年。结果:妊娠期无复发报告,提示NTZ治疗持续有效。然而,14名母亲中有1名经历了产后临床事件,没有伴随的MRI活动MRI发现,另外2名患者在分娩后1个月内进行MRI检查时出现了单独的病变负荷增加,没有临床复发。新生儿结局良好,出生参数正常,没有感染或发育迟缓,在母乳喂养期间接触或未接触NTZ的新生儿之间没有差异。结论:妊娠期和哺乳期NTZ治疗与良好的孕产妇和新生儿结局相关,随访时间长达10年。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Neurological Sciences
Neurological Sciences 医学-临床神经学
CiteScore
6.10
自引率
3.00%
发文量
743
审稿时长
4 months
期刊介绍: Neurological Sciences is intended to provide a medium for the communication of results and ideas in the field of neuroscience. The journal welcomes contributions in both the basic and clinical aspects of the neurosciences. The official language of the journal is English. Reports are published in the form of original articles, short communications, editorials, reviews and letters to the editor. Original articles present the results of experimental or clinical studies in the neurosciences, while short communications are succinct reports permitting the rapid publication of novel results. Original contributions may be submitted for the special sections History of Neurology, Health Care and Neurological Digressions - a forum for cultural topics related to the neurosciences. The journal also publishes correspondence book reviews, meeting reports and announcements.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信