BETAFERON and interferon beta pregnancy data

 

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Overall, more than 2,000 interferon beta-exposed pregnancy outcomes have been prospectively collected across various registries [1-5]. The largest dataset specific to interferon beta-1b is derived from the Bayer pharmacovigilance database [1].

Bayer pharmacovigilance database

 

Multiple observational studies looked at pregnancy outcomes of all interferon beta therapies in registries or registers.

The European Interferon Beta Pregnancy Registry (2020) [2]

The register-based cohort study in Finland and Sweden (2020) [3]

The German Pregnancy Registry (2016) [4]

The Italian Pregnancy Registry (2010) [5]

All datasets have consistently reported no increase in negative outcome associated with exposure to BETAFERON or any another interferon beta therapy before or during pregnancy [1-5].

 

In all studies, the rates of spontaneous abortions and congenital anomalies were assessed. The register-based cohort study in Finland and Sweden also evaluated fetal growth parameters such as birth weight, birth height and head circumference or gestational age among infants of women with MS. In most cases, BETAFERON / interferon beta exposure occurred in early pregnancy during the first trimester, and therapy was typically stopped when pregnancy was confirmed [6].

 

MS activity during pregnancy

Experience with BETAFERON / interferon beta exposure during the second and third trimester of pregnancy remains limited [6]. However, if clinically needed, BETAFERON may be considered during pregnancy [6].

According to expert opinion and clinical practice guidelines, interferon beta therapy like BETAFERON may be continued until pregnancy is confirmed [4,5,7-11].

References

  • Hellwig K et al. Ther Adv Neurol Disord 2020; 13: 1756286420910310. Return to content
  • Hellwig K et al. J Neurol 2020; doi: 10.1007/s00415-020-09762-y. Return to content
  • Hakkarainen KM et al. Ther Adv Neurol Disord 2020; 13: 1-15. Return to content
  • Thiel S et al. Mult Scler 2016; 22(6): 801-809. Return to content
  • Amato MP et al. Neurology 2010; 75(20): 1794-802. 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
  • Hellwig K. Eur Neurol 2014; 72(Suppl 1): 39-42. Return to content
  • Amato MP, Portaccio E. CNS Drugs 2015; 29(3): 207-20. Return to content
  • Thöne J et al. Expert Opin Drug Saf 2017; 16(5): 523-34. Return to content
  • Kompetenznetz Multiple Sklerose: Qualitätshandbuch, 2020. Accessed on March 6 2020. Available at: https://www.kompetenznetz-multiplesklerose.de/wp-content/uploads/2020/03/KKNMS_Qualitätshandbuch-MSNMOSD_202001_webfrei-1.pdf Return to content
  • Liguori NF et al. Mult Scler Relat Disord 2020; 43: 102147. Return to content
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