Nirsevimab Safe for Infants With RSV, Significantly Reduces Hospitalization Incidence

A single intramuscular dose of nirsevimab significantly reduced hospitalization incidence among infants with RSV-associated LRTI, suggesting it may help reduce the overall burden of RSV disease.

Nirsevimab can reduce hospitalizations by 83.21% in infants younger than 12 months with respiratory syncytial virus (RSV)-related lower respiratory tract infection (LRTI), according to a press release published by Sanofi-Aventis Groupe.

The Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) phase 3b trial (ClinicalTrials.gov Identifier: NCT05437510) is a large interventional clinical trial to determine the safety and efficacy of a single intramuscular dose of nirsevimab. Real-world data were collected from more than 8000 infants across 250 treatment sites in Germany and the United Kingdom during the 2022 to 2023 RSV season.

[T]he overall burden on healthcare systems could be reduced significantly if all infants receive nirsevimab.

Compared with infants who received no RSV intervention, researchers observed that 1 dose of nirsevimab led to reductions in several measures, as follows:

  • Hospitalizations due to RSV-related LRTI (83.21%; 95% CI, 67.77-92.04; P <.001);
  • Incident hospitalizations due to severe RSV-related LRTI (75.71%; 95% CI, 32.85-92.91; P <.001); and
  • Incident all-cause hospitalizations due to LRTI (58.04%; 95% CI, 39.69-71.19; P <.001).

Owing to these findings, “[T]he overall burden on healthcare systems could be reduced significantly if all infants receive nirsevimab,” the researchers noted.

References:

Nirsevimab delivers 83% reduction in RSV infant hospitalizations in a real-world clinical trial setting. Press release. Sanofi-Aventis Groupe; May 12, 2023. Accessed May 22, 2023. https://www.globenewswire.com/news-release/2023/05/12/2667568/0/en/Press-Release-Nirsevimab-delivers-83-reduction-in-RSV-infant-hospitalizations-in-a-real-world-clinical-trial-setting.html