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

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

Vilija G Jokubaitis  1   2 , Raed Alroughani  3 , Ayse Altintas  4 , Sara Eichau  5 , Stella Hughes  6 , Barbara Willekens  7 , Dana Horakova  8 , Eva Kubala Havrdova  8 , Serkan Ozakbas  9   10 , Cavit Boz  11 , Mario Habek  12 , Tomas Kalincik  13   14 , Izanne Roos  13   14 , Masoud Etemadifar  15 , Marek Peterka  16 , Jeannette Lechner-Scott  17   18 , Jose E Meca-Lallana  19 , Zuzana Rous  20 , Jana Houskova  21 , Alexandre Prat  22 , Marc Girard  22 , Radek Ampapa  23 , Katherine Buzzard  24 , Olga Skibina  2   24 , Nevin A John  25   26 , Allan G Kermode  27   28   29   30 , Marzena J Fabis-Pedrini  27   28   29 , Matteo Foschi  31   32 , Andrea Surcinelli  31 , Yolanda Blanco  33 , Seyed Mohammad Baghbanian  34 , Oliver Gerlach  35   36 , Richard Macdonell  37 , Zbysek Pavelek  38 , Pavel Stourac  39 , Pamela McCombe  40 , Guy Laureys  41 , Helmut Butzkueven  1   2 , Anneke van der Walt  1   2 , Orla Gray  42 ; MSBase Study Investigators
Collaborators, Affiliations

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

Vilija G Jokubaitis et al. Mult Scler. 2025 Aug.

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.

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

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Conflict of interest statement

Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: VGJ Receives research fellowship support from the National Health and Medical Research Council of Australia (2025360). Her institution receives research funding support from F.Hoffmann-La Roche, the International Progressive MS Alliance, Multiple Sclerosis Australia and the Pennycook Foundation outside of this current work. She has received speaker’s honoraria from Novartis and The Limbic.RA received honoraria as a speaker and for serving on scientific advisory boards from Bayer, Biogen, GSK, Merck, Novartis, Roche, and Sanofi Genzyme.AA received speaker honoraria from Alexion and travel grant from Ali Raif Ilac, Merck.SE have received speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck, Janssen, Bristol-Meyers, Bayer, Sanofi Genzyme, Roche and Teva.SH has received unrestricted educational grants or speaking honoraria from Biogen, Merck Serono, Novartis, Roche, and Sanofi Genzyme.BW received honoraria for acting as a member of Scientific Advisory Boards/Consultancy for Alexion, Almirall, Biogen, Celgene/BMS, Merck, Janssen, Novartis, Roche, Sandoz, Sanofi Genzyme and speaker honoraria and travel support from Biogen, Celgene/BMS, Merck, Novartis, Roche, Sanofi Genzyme; research and/or patient support grants from Biogen, Janssen, Merck, Sanofi Genzyme, Roche. Honoraria and grants were paid to the UZA/UZA Foundation. Further, B.W. received research funding from FWO-TBM, Belgian Charcot Foundation, Start2Cure Foundation, Queen Elisabeth Medical Foundation for Neurosciences, and the National MS Society USA.DH was supported by the Charles University: Cooperation Program in Neuroscience, by the project National Institute for Neurological Research (Programme EXCELES, ID Project No. LX22NPO5107)—Funded by the European Union—Next Generation EU, and by General University Hospital in Prague project MH CZ-DRO-VFN64165. She also received compensation for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck, Bayer, Sanofi Genzyme, Roche, and Teva, as well as support for research activities from Biogen Idec.EKH received honoraria/research support from Biogen, Merck Serono, Novars, Roche, and Teva; has been member of advisory boards for Actelion, Biogen, Celgene, Merck Serono, Novars, and Sanofi Genzyme; received honoraria/research support from Biogen, Merck Serono, Novars, Roche, and Teva; has been member of advisory boards for Actelion, Biogen, Celgene, Merck Serono, Novars, and Sanofi Genzyme; and has been supported by the Czech Ministry of Education—project Cooperation LF1, research area Neuroscience, and the project National Institute for Neurological Research (Programme EXCELES, ID project No LX22NPO5107)—funded by the European Union-Next Generation EU.SO reports no disclosures.CB received conference travel support from Biogen, Novartis, Bayer Schering, Merck and Teva; has participated in clinical trials by Sanofi-Aventis, Roche and Novartis.MH Received consultation and/or speaker fees from Biogen, Merck, Novartis, Roche, AstraZeneca, Amgen.TK Tomas Kalincik served on scientific advisory boards or as a consultant for MS International Federation and World Health Organization, Therapeutic Goods Administration, BMS, Roche, Janssen, Genzyme, Novartis, Merck and Biogen, received conference travel support and/or speaker honoraria from WebMD Global, Merck, Sandoz, Novartis, Biogen, Roche, Eisai, Genzyme, Teva and BioCSL and received research or educational event support from Biogen, Novartis, Genzyme, Roche, Celgene and Merck.IR served on scientific advisory boards, received conference travel support and/or speaker honoraria from Roche, Novartis, Merck and Biogen. Izanne Roos is supported by MS Australia and the Trish Multiple Sclerosis Research Foundation.ME reports no disclosures.MP received honoraria and travel grants from the following pharmaceutical companies: Biogen, Bristol-Myers Squibb, Genzyme, Janssen-Cilag, Merck Serono, Novartis, Roche, and Teva Pharma.JLS has received travel compensation from Novartis, Biogen, Roche and Merck. Her institution receives the honoraria for talks and advisory board commitment as well as research grants from Biogen, Merck, Roche and Novartis.JEML Jose E. Meca-Lallana has received honoraria as a consultant, as a chairman or lecturer in meetings and has participated in clinical trials and other research projects promoted by Alexion, Almirall, Biogen, Bristol Myers Squibb, Horizon, Johnson & Johnson, Merck, Neuraxpharm, Novartis, Roche, Sandoz, Sanofi and UCB.ZR reports no disclosures.JH received compensations for travel and consultant fees form Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen-Cilag.AP reports no disclosures.MG reports no disclosures.RA received conference travel support from Novartis, Teva, Biogen, Bayer and Merck and has participated in clinical trials by Biogen, Novartis, Teva and Actelion.KB received speaker honoraria and/or education support from Biogen, Teva, Novartis, Genzyme-Sanofi, Roche, Merck and Alexion; has been a member of advisory boards for Merck and Biogen.OS received honoraria and consulting fees from Bayer Schering, Novartis, Merck, Biogen and Genzyme.NAJ is a PI on commercial MS studies sponsored by Novartis, Roche, Biogen and Sanofi. He has received speaker’s honoraria from Merck. He has had conference travel and registration reimbursement; and consultancy fees from Novartis.AGK Served on Scientific Advisory Boards for Bayer, BioCSL, Biogen Idec, Clene Nanomedicine, Esai, Innate Immunotherapeutics, Lgpharma, Merck, Mitsubishi Tanabe Pharma, NeuroScientific Biopharmaceuticals, Novartis, Progenis, Roche, Sanofi-Aventis, Sanofi Genzyme, Teva, and View Health.MJF-P received travel compensation from Merck.MF received travel and meeting attendance support from Novartis, Biogen, Roche, Sanofi Genzyme and Merck.AS received travel and meeting attendance support from Novartis, Biogen, Roche, Merck, Bristol, Sanofi Genzyme, Almirall, Piam.YB received speaker honoraria/consulting fees from Merck, Biogen, Roche, Brystol, Novartis, Sanofi and Sandoz.SMB has served on scientific advisory boards and have received conference travel support and/or speaker honoraria from several pharmaceutical companies including Roche, Novartis, Merck, Cinnagen, Nanoalvand and Biogen.OG reports no disclosures.RM or his institution has received remuneration for his speaking engagements, advisory board memberships, research and travel from Biogen, Merck, Genzyme, Bayer, Roche, Teva, Novartis, CSL, BMS, MedDay and NHMRC.ZP received honoraria and travel grants from the following pharmaceutical companies: Biogen, Bristol-Myers Squibb, Eli Lilly, Genzyme, Janssen-Cilag, Lundbeck, Merck Serono, Novartis, Roche, and Teva Pharma.PS received compensations for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Teva and Janssen-Cilag.PMC received speakers fees and travel grants from Novartis, Biogen, T’évalua, SanofiGL received travel and/or consultancy compensation from Sanofi Genzyme, Roche, Teva, Merck, Novartis, Celgene, Biogen.HB is an employee of Monash University and has accepted travel compensation from Merck; his institution receives honoraria for talks, steering committee activities, and research grants from Roche, Merck, Biogen, Novartis, and UCB Pharma, Medical Research Future Fund Australia, NHMRC Australia, Trish MS Foundation, MS Australia and the Pennycook Foundation. He receives personal compensation for steering group activities for the Brain Health Initiative from Oxford Health Policy Forum and is funded by an NHMRC Australia Investigator Grant.AVDW served on advisory boards and receives unrestricted research grants from Novartis, Biogen, Merck, and Roche She has received speaker’s honoraria and travel support from Novartis, Roche, and Merck. She receives grant support from the National Health and Medical Research Council of Australia and MS Research Australia.OG received honoraria as consultant on scientific advisory boards for Genzyme, Biogen, Merck, Roche, and Novartis; has received travel grants from Biogen, Merck, Roche, and Novartis; has participated in clinical trials by Biogen and Merck. Her institution has received research grant support from Biogen.

Figures

Figure 1.
Figure 1.
Consort flow diagram of study inclusion showing the number of pregnancies prospectively recorded, stratified by disease phenotype: radiologically isolated syndrome (RIS), relapse-onset MS (including secondary progressive MS), progressive-onset MS, and neuromyelitis optica spectrum disorder (NMOSD).
Figure 2.
Figure 2.
Number of pregnancies prospectively recorded by country, or region if fewer than 10 captured. This figure further displays the differences in regional peripartum management, showing the number of disease-modifying therapy (DMT) exposures during pregnancy, categorized by DMT type: none; interferons, glatiramer acetate or dimethyl fumarate (IFN/GA/DMF); monoclonal antibodies (Mabs, including: natalizumab, ocrelizumab, ofatumumab, rituximab, alemtuzumab); and all other therapies.
Figure 3.
Figure 3.
Frequencies and patterns of disease-modifying therapy (DMT) exposure 6 months preconception, during pregnancy (for any duration) and in the first 3 months postpartum in women with relapse-onset MS. DMTs with fewer than five exposures grouped together in the “other” category.
See this image and copyright information in PMC

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