Nirsevimab delivers 83% reduction in RSV infant hospitalisations in a real-world clinical trial setting
New data from the HARMONIE clinical trial shows an 83% reduction in hospitalisations due to RSV-related lower respiratory tract diseases (LRTD) in infants under 12 months who receive a single dose of nirsevimab, when compared to those who receive no intervention.
The Hospitalised RSV Monoclonal Antibody Prevention (HARMONIE) study is a Europe-wide clinical trial which aims to determine the safety and efficacy of a single intramuscular dose of nirsevimab to treat illnesses caused by RSV (respiratory syncytial virus).
Data from the project, a collaboration between Sanofi, AstraZeneca and the National Institute of Health and Care Research, demonstrated that nirsevimab reduced the incidence of hospitalizations due to severe RSV-related LRTD (patients whose oxygen levels are under 90% and require oxygen supplementation) by 75%.
It also found a reduction of 58% in the occurrence of all-cause LRTD hospitalisations compared to infants who received no RSV intervention. Therefore, nirsevimab could relieve a large burden on healthcare systems should all infants receive it.
Dr Simon Drysdale, Consultant Paediatrician in Infectious Diseases at St. George’s University Hospital NHS Foundation Trust and Co-Chief Investigator of HARMONIE said:
“RSV-related chest infections lead to high numbers of infants under 12 months old being hospitalised every year. These data reinforce the potential public health benefit of nirsevimab in terms of helping to reduce the strain on hospitals caused each year by RSV.”
Throughout HARMONIE, nirsevimab maintained a favourable safety profile, consistent with the pivotal trial results.