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四年后:MSBase妊娠、新生儿结局及女性健康登记处(2020 - 2024年)报告的妊娠与分娩结局

Four years on: Pregnancy and birth outcomes reported in the MSBase pregnancy, neonatal outcomes, and Women's Health Registry (2020-2024).

作者信息

Jokubaitis Vilija G, Alroughani Raed, Altintas Ayse, Eichau Sara, Hughes Stella, Willekens Barbara, Horakova Dana, Havrdova Eva Kubala, Ozakbas Serkan, Boz Cavit, Habek Mario, Kalincik Tomas, Roos Izanne, Etemadifar Masoud, Peterka Marek, Lechner-Scott Jeannette, Meca-Lallana Jose E, Rous Zuzana, Houskova Jana, Prat Alexandre, Girard Marc, Ampapa Radek, Buzzard Katherine, Skibina Olga, John Nevin A, Kermode Allan G, Fabis-Pedrini Marzena J, Foschi Matteo, Surcinelli Andrea, Blanco Yolanda, Baghbanian Seyed Mohammad, Gerlach Oliver, Macdonell Richard, Pavelek Zbysek, Stourac Pavel, McCombe Pamela, Laureys Guy, Butzkueven Helmut, van der Walt Anneke, Gray Orla

机构信息

Department of Neuroscience, School of Translational Medicine, Monash University, Melbourne, VIC, Australia.

Department of Neurology, Alfred Health, Melbourne, VIC, Australia.

出版信息

Mult Scler. 2025 Aug;31(9):1088-1101. doi: 10.1177/13524585251349125. Epub 2025 Jul 7.

Abstract

BACKGROUND

Family planning is an important aspect of multiple sclerosis (MS), and neuromyelitis optica spectrum disorder (NMOSD) management. Knowledge gaps remain, including optimal perinatal management strategies, and fetal risks associated with disease-modifying therapy (DMT) exposure.

OBJECTIVE

To describe perinatal DMT use, together with pregnancy and neonatal outcomes prospectively recorded in the International MSBase Pregnancy and Women's Health Registry.

METHODS

We report summary statistics for data collected between May 2020 and August 2024.

RESULTS

A total of 1887 relapsing-remitting MS (RRMS), 12 primary-progressive MS (PPMS), 2 radiologically isolated syndrome (RIS) and 21 NMOSD completed pregnancies were recorded, including 1644 (85.5%) live births, 208 (10.8%) miscarriages, and 6 (0.3%) neonatal deaths. Most women had unassisted (53.8%) or assisted (7.4%) vaginal births. Seventy five percent of pregnancies had DMT exposures within 6 months preconception; 19% of NMOSD, and 62% of MS pregnancies were DMT-exposed during gestation; 18.1% of pregnancies reported in-pregnancy monoclonal antibody DMT exposure. No overt safety signals were seen.

CONCLUSION

This first report from the newly launched MSBase pregnancy registry, establishes an increasing number of pregnancies being conceived on monoclonal antibody therapies. Although no safety signals were observed, it is important to continue monitoring for safety signals in real-world databases as the use of highly effective therapies continues to increase perinatally.

摘要

背景

计划生育是多发性硬化症(MS)和视神经脊髓炎谱系障碍(NMOSD)管理的重要方面。知识空白仍然存在,包括最佳围产期管理策略以及与疾病修饰疗法(DMT)暴露相关的胎儿风险。

目的

描述围产期DMT的使用情况,以及在国际MSBase妊娠与女性健康登记处前瞻性记录的妊娠和新生儿结局。

方法

我们报告了2020年5月至2024年8月期间收集的数据的汇总统计信息。

结果

共记录了1887例复发缓解型MS(RRMS)、12例原发进展型MS(PPMS)、2例放射学孤立综合征(RIS)和21例NMOSD的妊娠情况,包括1644例(85.5%)活产、208例(10.8%)流产和6例(0.3%)新生儿死亡。大多数女性为自然阴道分娩(53.8%)或辅助阴道分娩(7.4%)。75%的妊娠在受孕前6个月内暴露于DMT;19%的NMOSD妊娠和62%的MS妊娠在妊娠期暴露于DMT;18.1%的妊娠报告在孕期暴露于单克隆抗体DMT。未发现明显的安全信号。

结论

新启动的MSBase妊娠登记处的这份首份报告显示,越来越多的妊娠是在接受单克隆抗体治疗的情况下受孕的。尽管未观察到安全信号,但随着围产期高效疗法的使用持续增加,在真实世界数据库中持续监测安全信号非常重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/38ab/12357973/e1aa24d9dc3a/10.1177_13524585251349125-fig1.jpg

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