Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants
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Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants. / Drysdale, Simon B; Cathie, Katrina; Flamein, Florence; Knuf, Markus; Collins, Andrea M; Hill, Helen C; 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; Faust, Saul N; HARMONIE Study Group.
in: NEW ENGL J MED, Jahrgang 389, Nr. 26, 28.12.2023, S. 2425-2435.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants
AU - Drysdale, Simon B
AU - Cathie, Katrina
AU - Flamein, Florence
AU - Knuf, Markus
AU - Collins, Andrea M
AU - Hill, Helen C
AU - Kaiser, Friedrich
AU - Cohen, Robert
AU - Pinquier, Didier
AU - Felter, Christian T
AU - Vassilouthis, Natalya C
AU - Jin, Jing
AU - Bangert, Mathieu
AU - Mari, Karine
AU - Nteene, Rapi
AU - Wague, Sophie
AU - Roberts, Michelle
AU - Tissières, Pierre
AU - Royal, Simon
AU - Faust, Saul N
AU - HARMONIE Study Group
AU - Schulze-Sturm, Ulf
N1 - Copyright © 2023 Massachusetts Medical Society.
PY - 2023/12/28
Y1 - 2023/12/28
N2 - BACKGROUND: 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.METHODS: 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.RESULTS: 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.CONCLUSIONS: 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).
AB - BACKGROUND: 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.METHODS: 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.RESULTS: 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.CONCLUSIONS: 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).
KW - Humans
KW - Infant
KW - Antibodies, Monoclonal, Humanized/administration & dosage
KW - Hospitalization
KW - Respiratory Syncytial Virus Infections/prevention & control
KW - Respiratory Syncytial Virus, Human
KW - Respiratory Tract Infections/prevention & control
KW - Injections, Intramuscular
U2 - 10.1056/NEJMoa2309189
DO - 10.1056/NEJMoa2309189
M3 - SCORING: Journal article
C2 - 38157500
VL - 389
SP - 2425
EP - 2435
JO - NEW ENGL J MED
JF - NEW ENGL J MED
SN - 0028-4793
IS - 26
ER -