The register-based cohort study among women with MS in Finland and Sweden


 

This cohort study significantly contributed to the understanding of real-world interferon beta exposed pregnancies. The nature of the study (data from national registers) allowed a comparison between interferon beta-exposed and unexposed pregnancies. The study period was 1996 to 2014 for Finland and 2005 to 2014 for Sweden. Pregnancy outcomes and characteristics of live births prenatally exposed to interferon beta as the only MS medication were compared to those unexposed to any disease-modifying therapy [1,2].

 

 

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Pregnancy outcome measures [1]


 

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This cohort study significantly contributed to the understanding of real-world interferon beta exposed pregnancies. The nature of the study (data from national registers) allowed a comparison between interferon beta-exposed and unexposed pregnancies. The study period was 1996 to 2014 for Finland and 2005 to 2014 for Sweden. Pregnancy outcomes and characteristics of live births prenatally exposed to interferon beta as the only MS medication were compared to those unexposed to any disease-modifying therapy [1,2].

 

Characteristics of live births [2]


 

 

No differences in mean gestational age at birth were found between infants prenatally exposed to interferon beta vs those unexposed to any MS disease modifying medication. Likewise, measurements taken at birth were in the same range for both groups. In the adjusted analyses, relative to those unexposed, infants prenatally exposed to interferon were on average:

 

  • 28 grams heavier (p=0.17) in Sweden and 50 grams lighter (p=0.26) in Finland;
  • 0.01 cm longer (p=0.95) in Sweden and 0.02 cm shorter (p=0.92) in Finland;
  • and had a head circumference of 0.14 cm larger (p=0.13) in Sweden and 0.22 cm smaller (p=0.15) in Finland

 

This large, population-based study showed no evidence that interferon beta exposure before conception and/or during early pregnancy increased the rate of major congenital anomalies or spontaneous abortions [1]. Furthermore, it indicates no association between interferon beta exposure and fetal growth (i.e. birth weight, birth high and head circumference) among infants of women with MS [2].

 

The data support the recently updated European BETAFERON Sumary of Product Characteristics stating that if clinically needed, BETAFERON may be considered during pregnancy [3].

 

 

 

Access to open access publications:

Hakkarainen et al. 2020 Burkill et al. 2019

References

  • Hakkarainen KM et al. Ther Adv Neurol Disord 2020; 13: 1-15. Return to content
  • Burkill S et al. PLoS ONE 14(12): e0227120. Return to content
  • BETAFERON® European Summary of Product Characteristics, October 2020. Available at: https://www.ema.europa.eu/en/documents/product-information/betaferon-epar-product-information_en.pdf Return to content
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