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

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Four years on: Pregnancy and birth outcomes reported in the MSBase pregnancy, neonatal outcomes, ...

Přehled o publikaci

J 2025

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

JOKUBAITIS, Vilija G; Raed ALROUGHANI; Ayse ALTINTAS; Sara EICHAU; Stella HUGHES et. al.

Basic information

Original name

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

Authors

Edition

MULTIPLE SCLEROSIS JOURNAL, LONDON, SAGE PUBLICATIONS LTD, 2025, 1352-4585

Other information

Language

English

Type of outcome

Article in a journal

Confidentiality degree

is not subject to a state or trade secret

References:

URL

Organization

Lékařská fakulta – Repository – Repository

DOI

https://doi.org/10.1177/13524585251349125

UT WoS

001523711300001

EID Scopus

999

Keywords in English

Multiple sclerosis; neuromyelitis optica spectrum disorder; pregnancy; disease-modifying therapy; neonatal outcomes

Links

LX22NPO5107, research and development project.

Changed: 8/8/2025 00:51, RNDr. Daniel Jakubík

Abstract

In the original language

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.

Files attached

https://is.muni.cz/publication/2511317/Four_years_on_Pregnancy_and_birth_outcomes_reported_in_the_MSBase_pregnancy__neonatal_outcomes__and_Women_s_Health_Registry__2020-2024_.pdf File version

Cite

JOKUBAITIS, Vilija G; Raed ALROUGHANI; Ayse ALTINTAS; Sara EICHAU; Stella HUGHES; Barbara WILLEKENS; Dana HORAKOVA; Eva Kubala HAVRDOVA; Serkan OZAKBAS; Cavit BOZ; Mario HABEK; Tomas KALINCIK; Izanne ROOS; Masoud ETEMADIFAR; Marek PETERKA; Jeannette LECHNER-SCOTT; Jose E MECA-LALLANA; Zuzana ROUS; Jana HOUSKOVA; Alexandre PRAT; Marc GIRARD; Radek AMPAPA; Katherine BUZZARD; Olga SKIBINA; Nevin A JOHN; Allan G KERMODE; Marzena J FABIS-PEDRINI; Matteo FOSCHI; Andrea SURCINELLI; Yolanda BLANCO; Seyed Mohammad BAGHBANIAN; Oliver GERLACH; Richard MACDONELL; Zbysek PAVELEK; Pavel ŠTOURAČ; Pamela MCCOMBE; Guy LAUREYS; Helmut BUTZKUEVEN; van der Walt ANNEKE and Orla GRAY. Four years on: Pregnancy and birth outcomes reported in the MSBase pregnancy, neonatal outcomes, and Women's Health Registry (2020-2024). MULTIPLE SCLEROSIS JOURNAL. LONDON: SAGE PUBLICATIONS LTD, 2025, vol. 56, No 2, p. 447-455, 14 pp. ISSN 1352-4585. Available from: https://doi.org/10.1177/13524585251349125.

@article{80208,
   author = {Jokubaitis, Vilija G and Alroughani, Raed and Altintas, Ayse and Eichau, Sara and Hughes, Stella and Willekens, Barbara and Horakova, Dana and Havrdova, Eva Kubala and Ozakbas, Serkan and Boz, Cavit and Habek, Mario and Kalincik, Tomas and Roos, Izanne and Etemadifar, Masoud and Peterka, Marek and LechnerandScott, Jeannette and MecaandLallana, Jose E and Rous, Zuzana and Houskova, Jana and Prat, Alexandre and Girard, Marc and Ampapa, Radek and Buzzard, Katherine and Skibina, Olga and John, Nevin A and Kermode, Allan G and FabisandPedrini, Marzena J and Foschi, Matteo and Surcinelli, Andrea and Blanco, Yolanda and Baghbanian, Seyed Mohammad and Gerlach, Oliver and Macdonell, Richard and Pavelek, Zbysek and ŠTOURAČ, Pavel and McCombe, Pamela and Laureys, Guy and Butzkueven, Helmut and Anneke, van der Walt and Gray, Orla},
   article_location = {LONDON},
   article_number = {2},
   doi = {https://doi.org/10.1177/13524585251349125},
   keywords = {Multiple sclerosis; neuromyelitis optica spectrum disorder; pregnancy; disease-modifying therapy; neonatal outcomes},
   language = {eng},
   issn = {1352-4585},
   journal = {MULTIPLE SCLEROSIS JOURNAL},
   title = {Four years on: Pregnancy and birth outcomes reported in the MSBase pregnancy, neonatal outcomes, and Women's Health Registry (2020-2024)},
   url = {https://journals.sagepub.com/doi/10.1177/13524585251349125},
   volume = {56},
   year = {2025}
}

TY  - JOUR
ID  - 80208
AU  - 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 - ŠTOURAČ, Pavel - McCombe, Pamela - Laureys, Guy - Butzkueven, Helmut - Anneke, van der Walt - Gray, Orla
PY  - 2025
TI  - Four years on: Pregnancy and birth outcomes reported in the MSBase pregnancy, neonatal outcomes, and Women's Health Registry (2020-2024)
JF  - MULTIPLE SCLEROSIS JOURNAL
VL  - 56
IS  - 2
SP  - 447-455
EP  - 447-455
PB  - SAGE PUBLICATIONS LTD
SN  - 1352-4585
KW  - Multiple sclerosis
KW  - neuromyelitis optica spectrum disorder
KW  - pregnancy
KW  - disease-modifying therapy
KW  - neonatal outcomes
UR  - https://journals.sagepub.com/doi/10.1177/13524585251349125
N2  - 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.
ER  -

JOKUBAITIS, Vilija G; Raed ALROUGHANI; Ayse ALTINTAS; Sara EICHAU; Stella HUGHES; Barbara WILLEKENS; Dana HORAKOVA; Eva Kubala HAVRDOVA; Serkan OZAKBAS; Cavit BOZ; Mario HABEK; Tomas KALINCIK; Izanne ROOS; Masoud ETEMADIFAR; Marek PETERKA; Jeannette LECHNER-SCOTT; Jose E MECA-LALLANA; Zuzana ROUS; Jana HOUSKOVA; Alexandre PRAT; Marc GIRARD; Radek AMPAPA; Katherine BUZZARD; Olga SKIBINA; Nevin A JOHN; Allan G KERMODE; Marzena J FABIS-PEDRINI; Matteo FOSCHI; Andrea SURCINELLI; Yolanda BLANCO; Seyed Mohammad BAGHBANIAN; Oliver GERLACH; Richard MACDONELL; Zbysek PAVELEK; Pavel ŠTOURAČ; Pamela MCCOMBE; Guy LAUREYS; Helmut BUTZKUEVEN; van der Walt ANNEKE and Orla GRAY. Four years on: Pregnancy and birth outcomes reported in the MSBase pregnancy, neonatal outcomes, and Women's Health Registry (2020-2024). \textit{MULTIPLE SCLEROSIS JOURNAL}. LONDON: SAGE PUBLICATIONS LTD, 2025, vol.~56, No~2, p.~447-455, 14 pp. ISSN~1352-4585. Available from: https://doi.org/10.1177/13524585251349125.