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Prevalence of adverse pregnancy outcomes after exposure to interferon beta prior to or during pregnancy in women with MS: Stratification by maternal and newborn characteristics in a register-based cohort study in Finland and Sweden
StatFinn-EPID Research, Tallinn, Estonia.
StatFinn-EPID Research, Mölndal, Sweden.
Karolinska Institute, Solna, Sweden.
Novartis Pharma AG, Evidence and Launch Excellence, Basel, Switzerland.
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2020 (English)In: Multiple Sclerosis and Related Disorders, ISSN 2211-0348, E-ISSN 2211-0356, Vol. 48, article id 102694Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Previous studies reported no increase in the prevalence of adverse pregnancy outcomes after exposure to interferon-beta (IFN-beta). However, no study has investigated if the prevalence of these outcomes after IFN-beta exposure is modified by maternal and newborn characteristics. Our objective was to describe the stratified prevalence of adverse pregnancy outcomes among women with multiple sclerosis (MS) exposed only to IFN-beta or unexposed to any MS disease modifying drugs (MSDMDs).

METHODS: This population-based cohort study using Finnish (1996-2014) and Swedish (2005-2014) register data included pregnancies of women with MS exposed only to IFN-beta 6 months before or during pregnancy (n=718) or unexposed to MSDMDs (n=1397). The outcome prevalences were described stratified by maternal and newborn characteristics, with 95% confidence intervals (CIs). Confounder-adjusted analyses were performed if the prevalence results indicated modified effect of IFN-beta in specific strata.

RESULTS: The stratified analysis indicated that the prevalence of serious (anomaly or stillbirth) and other adverse pregnancy outcomes was similar among the exposed and unexposed, with no statistically significant difference. Among women treated for MS >5 years, serious adverse pregnancy outcomes occurred in 4.3% (95%CI: 1.9-8.3%) of pregnancies exposed only to IFN-beta 6 months before or during pregnancy and in 2.7% (95%CI: 1.2-5.0%) of unexposed pregnancies. The confounder adjusted analyses did not support the hypothesis that MS treatment duration before pregnancy would modify the risk of adverse pregnancy outcomes after exposure to IFN-beta 6 months before or during pregnancy.

CONCLUSION: The prevalence of adverse pregnancy outcomes was not increased after IFN-beta exposure, when pregnancies of women with MS were stratified by maternal and newborn characteristics. The stratified results were similar to the unstratified results in the same population.

Place, publisher, year, edition, pages
Elsevier, 2020. Vol. 48, article id 102694
Keywords [en]
Adverse pregnancy outcomes, Interferon-beta, Multiple sclerosis, Pregnancy, Stratification
National Category
Gynaecology, Obstetrics and Reproductive Medicine
Identifiers
URN: urn:nbn:se:oru:diva-88483DOI: 10.1016/j.msard.2020.102694ISI: 000657748800012PubMedID: 33429303Scopus ID: 2-s2.0-85099012565OAI: oai:DiVA.org:oru-88483DiVA, id: diva2:1517308
Note

Funding Agencies:

Bayer AG 

Biogen 

Merck KGaA  

Novartis Europharm Limited

Available from: 2021-01-13 Created: 2021-01-13 Last updated: 2025-02-11Bibliographically approved

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Montgomery, Scott

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