Four Years On: Pregnancy and Birth Outcomes Reported in the Msbase Pregnancy, Neonatal Outcomes, and Women’S Health Registry (2020–2024) Publisher Pubmed



Vg Jokubaitis Vilija G ; Ra Alroughani Raed A ; A Altintas AYSE ; S Eichau SARA ; Se Hughes Stella E ; B Willekens BARBARA ; D Horakova DANA ; Ek Kubala Havrdova Eva KUBALA ; S Ozakbas SERKAN ; C Boz CAVIT
Source: Multiple Sclerosis Journal Published:2025

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. © 2025 Elsevier B.V., All rights reserved.