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

VG. Jokubaitis, R. Alroughani, A. Altintas, S. Eichau, S. Hughes, B. Willekens, D. Horakova, EK. Havrdova, S. Ozakbas, C. Boz, M. Habek, T. Kalincik, I. Roos, M. Etemadifar, M. Peterka, J. Lechner-Scott, JE. Meca-Lallana, Z. Rous, J. Houskova, A....

. 2025 ; 31 (9) : 1088-1101. [pub] 20250707

Jazyk angličtina Země Anglie, Velká Británie

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc25022148

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.

Academic MS Center Zuyd Department of Neurology Zuyderland Medical Center Sittard Geleen the Netherlands

Al Amiri Hospital Sharq Kuwait

Center of Neuroimmunology Service of Neurology Hospital Clinic de Barcelona Barcelona Spain

CHUM MS Center and Universite de Montreal Montreal QC Canada

CORe Department of Medicine University of Melbourne Melbourne VIC Australia

Department of Biotechnological and Applied Clinical Sciences University of L'Aquila L'Aquila Italy

Department of Medicine School of Clinical Sciences Monash University Clayton VIC Australia

Department of Neurology Alfred Health Melbourne VIC Australia

Department of Neurology and Center of Clinical Neuroscience 1st Faculty of Medicine Charles University Prague and General University Hospital Prague Czech Republic

Department of Neurology Antwerp University Hospital Edegem Belgium

Department of Neurology Austin Health Melbourne VIC Australia

Department of Neurology Hunter New England Health John Hunter Hospital Newcastle NSW Australia

Department of Neurology Medical Faculty Karadeniz Technical University Trabzon Turkey

Department of Neurology Monash Health Clayton VIC Australia

Department of Neurology School for Mental Health and Neuroscience Maastricht University Medical Center Maastricht the Netherlands

Department of Neurology the University of Queensland Brisbane QLD Australia

Department of Neurology University Hospital Center Zagreb Zagreb Croatia School of Medicine University of Zagreb Zagreb Croatia

Department of Neurology University Hospital Ghent Brussels Belgium

Department of Neuroscience MS Center Neurology Unit S Maria delle Croci Hospital of Ravenna Ravenna Italy

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

Department of Neurosciences Eastern Health Clinical School Box Hill Hospital Monash University Box Hill VIC Australia

Faculty of Medicine and University Hospital Hradec Kralove Charles University Prague Hradec Kralove Czech Republic

Faculty of Medicine and University Hospital in Pilsen Charles University in Pilsen Plzen Czech Republic

Faculty of Medicine Isfahan university of Medical sciences Isfahan Iran

Faculty of Medicine Palacky University and University Hospital Olomouc Czech Republic

Hospital Ceske Budejovice Czech Republic

Hospital Universitario Virgen Macarena Sevilla Andalucía Spain

Hunter Medical Research Institute University of Newcastle

Institute for Immunology and Infectious Diseases Murdoch University Perth WA Australia

Izmir University of Economics Medical Point Hospital Izmir Turkey

Koc University School of Medicine and Koc University Research Center for Translational Medicine Istanbul Turkey

Masaryk University Brno and University Hospital Brno Czech Republic

Multiple Sclerosis CSUR Clinical Neuroimmunology Unit Neurology Department Virgen de la Arrixaca Clinical University Hospital IMIB Arrixaca and NICEM Cathedra UCAM Catholic University San Antonio Murcia Spain

Multiple Sclerosis Research Association Izmir Turkey

Nemocnice Jihlava Jihlava Czech Republic

Neuroimmunology Centre Department of Neurology Royal Melbourne Hospital Melbourne VIC Australia

Neurology Department Booalisina Hospital Faculty of Medicine Mazandaran University of Medical Sciences Sari Iran

Perron Institute for Neurological and Translational Science University of Western Australia Nedlands WA Australia

Personalised Medicine Centre Health Futures Institute Murdoch University Murdoch WA Australia

QEII Medical Centre Perth Australia

Royal Victoria Hospital Belfast UK

South Eastern HSC Trust Belfast UK

Citace poskytuje Crossref.org

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$a 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.
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