Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants.

Drysdale, Simon B, Cathie, Katrina, Flamein, Florence, Knuf, Markus, Collins, Andrea ORCID: https://orcid.org/0000-0002-4094-1572, Hill, Helen, Kaiser, Friedrich, Cohen, Robert, Pinquier, Didier, Felter, Christian T, Vassilouthis, Natalya C, Jin, Jing, Bangert, Mathieu, Mari, Karine, Nteene, Rapi, Wague, Sophie, Roberts, Michelle, Tissières, Pierre, Royal, Simon and Faust, Saul N (2023) 'Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants.'. New England Journal of Medicine, Vol 389, Issue 26, pp. 2425-2435.

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Abstract

The safety of the monoclonal antibody nirsevimab and the effect of nirsevimab on hospitalizations for respiratory syncytial virus (RSV)-associated lower respiratory tract infection when administered in healthy infants are unclear. In a pragmatic trial, we randomly assigned, in a 1:1 ratio, infants who were 12 months of age or younger, had been born at a gestational age of at least 29 weeks, and were entering their first RSV season in France, Germany, or the United Kingdom to receive either a single intramuscular injection of nirsevimab or standard care (no intervention) before or during the RSV season. The primary end point was hospitalization for RSV-associated lower respiratory tract infection, defined as hospital admission and an RSV-positive test result. A key secondary end point was very severe RSV-associated lower respiratory tract infection, defined as hospitalization for RSV-associated lower respiratory tract infection with an oxygen saturation of less than 90% and the need for supplemental oxygen. A total of 8058 infants were randomly assigned to receive nirsevimab (4037 infants) or standard care (4021 infants). Eleven infants (0.3%) in the nirsevimab group and 60 (1.5%) in the standard-care group were hospitalized for RSV-associated lower respiratory tract infection, which corresponded to a nirsevimab efficacy of 83.2% (95% confidence interval [CI], 67.8 to 92.0; P<0.001). Very severe RSV-associated lower respiratory tract infection occurred in 5 infants (0.1%) in the nirsevimab group and in 19 (0.5%) in the standard-care group, which represented a nirsevimab efficacy of 75.7% (95% CI, 32.8 to 92.9; P = 0.004). The efficacy of nirsevimab against hospitalization for RSV-associated lower respiratory tract infection was 89.6% (adjusted 95% CI, 58.8 to 98.7; multiplicity-adjusted P<0.001) in France, 74.2% (adjusted 95% CI, 27.9 to 92.5; multiplicity-adjusted P = 0.006) in Germany, and 83.4% (adjusted 95% CI, 34.3 to 97.6; multiplicity-adjusted P = 0.003) in the United Kingdom. Treatment-related adverse events occurred in 86 infants (2.1%) in the nirsevimab group. Nirsevimab protected infants against hospitalization for RSV-associated lower respiratory tract infection and against very severe RSV-associated lower respiratory tract infection in conditions that approximated real-world settings. (Funded by Sanofi and AstraZeneca; HARMONIE ClinicalTrials.gov number, NCT05437510).

Item Type:	Article
Corporate Authors:	HARMONIE Study Group
Subjects:	WC Communicable Diseases > Virus Diseases > Viral Respiratory Tract Infections. Respirovirus Infections > WC 505 Viral respiratory tract infections WF Respiratory System > WF 20 Research (General) WS Pediatrics > By Age Groups > WS 430 Infancy
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):	https://doi.org/10.1056/NEJMoa2309189
SWORD Depositor:	JISC Pubrouter
Depositing User:	JISC Pubrouter
Date Deposited:	25 Jan 2024 15:59
Last Modified:	28 Jun 2024 03:13
URI:	https://archive.lstmed.ac.uk/id/eprint/23838

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