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Background <p>Respiratory syncytial virus (RSV) is one of the most common pathogens causing severe respiratory infections in infants and young children. In 2023 immunization of all infants with the monoclonal antibody nirsevimab was recommended for the first time in various countries.</p> Objective <p>The aim of this systematic review is to summarize the early real-world evidence on the impact and effectiveness of nirsevimab in routine use.</p> Material and methods <p>A&#xa0;systematic literature search for publications from the years 2023 and 2024 was conducted in PubMed and Embase. Observational studies investigating the public health impact or effectiveness of nirsevimab in routine use were included in the review.</p> Results <p>This review article included 27 studies from Spain, France, the USA, Italy and Luxembourg. The reported immunization rates ranged from 69% in the Italian region of Valle d’Aosta to 99% in the Spanish region of Valladolid. The effectiveness of nirsevimab was assessed in 16&#xa0;studies, with 12&#xa0;reporting effectiveness against RSV-related hospitalization, ranging from 70% (95% confidence interval, CI: 38–89%) to 93% (95% CI: 82–97%). Of the studies 11 examined the public health impact of nirsevimab and reported a&#xa0;reduction in the RSV-associated disease burden.</p> Conclusion <p>Despite methodological differences in the studies, consistent positive effects of nirsevimab use were observed. After the first RSV season with widespread use the existing evidence suggests that nirsevimab can substantially reduce the RSV-associated disease burden and thus relieve the healthcare system during the RSV season.</p>

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Real World Evidence zur Prophylaxe von Erkrankungen durch das respiratorische Synzytialvirus bei Säuglingen mit Nirsevimab

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月16日

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  • Anna C. Meyer,
  • Moritz Wick,
  • Oliver Damm,
  • Saskia Kiesel,
  • Annika Wülfing,
  • Rolf Kramer,
  • Markus Knuf

摘要

Background

Respiratory syncytial virus (RSV) is one of the most common pathogens causing severe respiratory infections in infants and young children. In 2023 immunization of all infants with the monoclonal antibody nirsevimab was recommended for the first time in various countries.

Objective

The aim of this systematic review is to summarize the early real-world evidence on the impact and effectiveness of nirsevimab in routine use.

Material and methods

A systematic literature search for publications from the years 2023 and 2024 was conducted in PubMed and Embase. Observational studies investigating the public health impact or effectiveness of nirsevimab in routine use were included in the review.

Results

This review article included 27 studies from Spain, France, the USA, Italy and Luxembourg. The reported immunization rates ranged from 69% in the Italian region of Valle d’Aosta to 99% in the Spanish region of Valladolid. The effectiveness of nirsevimab was assessed in 16 studies, with 12 reporting effectiveness against RSV-related hospitalization, ranging from 70% (95% confidence interval, CI: 38–89%) to 93% (95% CI: 82–97%). Of the studies 11 examined the public health impact of nirsevimab and reported a reduction in the RSV-associated disease burden.

Conclusion

Despite methodological differences in the studies, consistent positive effects of nirsevimab use were observed. After the first RSV season with widespread use the existing evidence suggests that nirsevimab can substantially reduce the RSV-associated disease burden and thus relieve the healthcare system during the RSV season.