Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants
Copyright © 2023 Massachusetts Medical Society..
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).
Errataetall: |
CommentIn: N Engl J Med. 2024 Mar 21;390(12):1152. - PMID 38507765 |
---|---|
Medienart: |
E-Artikel |
Erscheinungsjahr: |
2023 |
---|---|
Erschienen: |
2023 |
Enthalten in: |
Zur Gesamtaufnahme - volume:389 |
---|---|
Enthalten in: |
The New England journal of medicine - 389(2023), 26 vom: 28. Dez., Seite 2425-2435 |
Sprache: |
Englisch |
---|
Beteiligte Personen: |
Drysdale, Simon B [VerfasserIn] |
---|
Links: |
---|
Themen: |
Antibodies, Monoclonal, Humanized |
---|
Anmerkungen: |
Date Completed 09.01.2024 Date Revised 20.03.2024 published: Print ClinicalTrials.gov: NCT05437510 CommentIn: N Engl J Med. 2024 Mar 21;390(12):1152. - PMID 38507765 Citation Status MEDLINE |
---|
doi: |
10.1056/NEJMoa2309189 |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
NLM366481541 |
---|
LEADER | 01000caa a22002652 4500 | ||
---|---|---|---|
001 | NLM366481541 | ||
003 | DE-627 | ||
005 | 20240321235806.0 | ||
007 | cr uuu---uuuuu | ||
008 | 240108s2023 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1056/NEJMoa2309189 |2 doi | |
028 | 5 | 2 | |a pubmed24n1338.xml |
035 | |a (DE-627)NLM366481541 | ||
035 | |a (NLM)38157500 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Drysdale, Simon B |e verfasserin |4 aut | |
245 | 1 | 0 | |a Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants |
264 | 1 | |c 2023 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ƒaComputermedien |b c |2 rdamedia | ||
338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Date Completed 09.01.2024 | ||
500 | |a Date Revised 20.03.2024 | ||
500 | |a published: Print | ||
500 | |a ClinicalTrials.gov: NCT05437510 | ||
500 | |a CommentIn: N Engl J Med. 2024 Mar 21;390(12):1152. - PMID 38507765 | ||
500 | |a Citation Status MEDLINE | ||
520 | |a Copyright © 2023 Massachusetts Medical Society. | ||
520 | |a 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 | ||
520 | |a 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 | ||
520 | |a 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 | ||
520 | |a 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) | ||
650 | 4 | |a Journal Article | |
650 | 4 | |a Multicenter Study | |
650 | 4 | |a Pragmatic Clinical Trial | |
650 | 4 | |a Randomized Controlled Trial | |
650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
650 | 7 | |a nirsevimab |2 NLM | |
650 | 7 | |a VRN8S9CW5V |2 NLM | |
700 | 1 | |a Cathie, Katrina |e verfasserin |4 aut | |
700 | 1 | |a Flamein, Florence |e verfasserin |4 aut | |
700 | 1 | |a Knuf, Markus |e verfasserin |4 aut | |
700 | 1 | |a Collins, Andrea M |e verfasserin |4 aut | |
700 | 1 | |a Hill, Helen C |e verfasserin |4 aut | |
700 | 1 | |a Kaiser, Friedrich |e verfasserin |4 aut | |
700 | 1 | |a Cohen, Robert |e verfasserin |4 aut | |
700 | 1 | |a Pinquier, Didier |e verfasserin |4 aut | |
700 | 1 | |a Felter, Christian T |e verfasserin |4 aut | |
700 | 1 | |a Vassilouthis, Natalya C |e verfasserin |4 aut | |
700 | 1 | |a Jin, Jing |e verfasserin |4 aut | |
700 | 1 | |a Bangert, Mathieu |e verfasserin |4 aut | |
700 | 1 | |a Mari, Karine |e verfasserin |4 aut | |
700 | 1 | |a Nteene, Rapi |e verfasserin |4 aut | |
700 | 1 | |a Wague, Sophie |e verfasserin |4 aut | |
700 | 1 | |a Roberts, Michelle |e verfasserin |4 aut | |
700 | 1 | |a Tissières, Pierre |e verfasserin |4 aut | |
700 | 1 | |a Royal, Simon |e verfasserin |4 aut | |
700 | 1 | |a Faust, Saul N |e verfasserin |4 aut | |
700 | 0 | |a HARMONIE Study Group |e verfasserin |4 aut | |
700 | 1 | |a Brouard, Jacques |e investigator |4 oth | |
700 | 1 | |a Leke, Andre |e investigator |4 oth | |
700 | 1 | |a Brevaut-Malaty, Veronique |e investigator |4 oth | |
700 | 1 | |a Epiard, Chloe |e investigator |4 oth | |
700 | 1 | |a Flamein, Florence |e investigator |4 oth | |
700 | 1 | |a Epaud, Ralph |e investigator |4 oth | |
700 | 1 | |a Somerville, David |e investigator |4 oth | |
700 | 1 | |a Thollot, Franck |e investigator |4 oth | |
700 | 1 | |a Dinh, Phu My Tran |e investigator |4 oth | |
700 | 1 | |a Lorrot, Mathie |e investigator |4 oth | |
700 | 1 | |a Werner, Andreas |e investigator |4 oth | |
700 | 1 | |a Froget, Rachel |e investigator |4 oth | |
700 | 1 | |a Razafimahefa, Hasinirina |e investigator |4 oth | |
700 | 1 | |a Fayon, Michael |e investigator |4 oth | |
700 | 1 | |a Brehin, Camille |e investigator |4 oth | |
700 | 1 | |a Boileau, Pascal |e investigator |4 oth | |
700 | 1 | |a Nguyen, Kim-An |e investigator |4 oth | |
700 | 1 | |a Guiheneuf, Cecile |e investigator |4 oth | |
700 | 1 | |a Lefevre, Claire |e investigator |4 oth | |
700 | 1 | |a Sarreau, Claire |e investigator |4 oth | |
700 | 1 | |a Kochert, Fabienne |e investigator |4 oth | |
700 | 1 | |a Huet, Frederic |e investigator |4 oth | |
700 | 1 | |a Seror, Elisa |e investigator |4 oth | |
700 | 1 | |a Cahn-Sellem, Fabienne |e investigator |4 oth | |
700 | 1 | |a Delavie, Nadege |e investigator |4 oth | |
700 | 1 | |a Batard, Christophe |e investigator |4 oth | |
700 | 1 | |a Corrard, François |e investigator |4 oth | |
700 | 1 | |a Zouari, Morched |e investigator |4 oth | |
700 | 1 | |a Gelbert-Baudino, Nathalie |e investigator |4 oth | |
700 | 1 | |a Carriere, Diane |e investigator |4 oth | |
700 | 1 | |a Maakaroun-Vermesse, Zoha |e investigator |4 oth | |
700 | 1 | |a Gaschignard, Jean |e investigator |4 oth | |
700 | 1 | |a Rioualen, Stephane |e investigator |4 oth | |
700 | 1 | |a Dugelay, Frederic |e investigator |4 oth | |
700 | 1 | |a Wollner, Alain |e investigator |4 oth | |
700 | 1 | |a Kassmann, Kai |e investigator |4 oth | |
700 | 1 | |a Pinquier, Didier |e investigator |4 oth | |
700 | 1 | |a Delobbe, Jean-Francois |e investigator |4 oth | |
700 | 1 | |a Cohen, Robert |e investigator |4 oth | |
700 | 1 | |a Cheve, Anne |e investigator |4 oth | |
700 | 1 | |a Bourlet, Anne |e investigator |4 oth | |
700 | 1 | |a Gras-Le Guen, Christele |e investigator |4 oth | |
700 | 1 | |a Nold, Benedicte |e investigator |4 oth | |
700 | 1 | |a Kireche, Bergengere |e investigator |4 oth | |
700 | 1 | |a Michot-Cottias, Anne-Sylvestre |e investigator |4 oth | |
700 | 1 | |a Lecaillier, Francine |e investigator |4 oth | |
700 | 1 | |a Achkar, Myrna |e investigator |4 oth | |
700 | 1 | |a Giovannini-Chami, Lisa |e investigator |4 oth | |
700 | 1 | |a Bsila, Aimen |e investigator |4 oth | |
700 | 1 | |a Vivalda, Laura |e investigator |4 oth | |
700 | 1 | |a Goehringer, Florence |e investigator |4 oth | |
700 | 1 | |a Poidvin, Amelie |e investigator |4 oth | |
700 | 1 | |a Magendie, Christine |e investigator |4 oth | |
700 | 1 | |a Georget, Emilie |e investigator |4 oth | |
700 | 1 | |a Desse, Blandine |e investigator |4 oth | |
700 | 1 | |a Gajdos, Vincent |e investigator |4 oth | |
700 | 1 | |a Jeziorski, Eric |e investigator |4 oth | |
700 | 1 | |a Naji, Sanaa |e investigator |4 oth | |
700 | 1 | |a Petit, Christian |e investigator |4 oth | |
700 | 1 | |a Mondenx, Mallorie |e investigator |4 oth | |
700 | 1 | |a Rondeleux, Emmanuelle |e investigator |4 oth | |
700 | 1 | |a Morand, Aurelie |e investigator |4 oth | |
700 | 1 | |a Kerdudo-Veau, Cecile |e investigator |4 oth | |
700 | 1 | |a Prevost, Blandine |e investigator |4 oth | |
700 | 1 | |a David, Alexandra |e investigator |4 oth | |
700 | 1 | |a Cornen, Gaelle |e investigator |4 oth | |
700 | 1 | |a Devulder, Christine |e investigator |4 oth | |
700 | 1 | |a Wellmann, Sven |e investigator |4 oth | |
700 | 1 | |a Koerner-Rettberg, Cordula |e investigator |4 oth | |
700 | 1 | |a Laub, Otto |e investigator |4 oth | |
700 | 1 | |a Scheele, Hartmut |e investigator |4 oth | |
700 | 1 | |a Praun, Manfred |e investigator |4 oth | |
700 | 1 | |a Knuf, Markus |e investigator |4 oth | |
700 | 1 | |a Wetzke, Martin |e investigator |4 oth | |
700 | 1 | |a Pabel, Helmut |e investigator |4 oth | |
700 | 1 | |a Petri, Andreas |e investigator |4 oth | |
700 | 1 | |a Thome, Ulrich |e investigator |4 oth | |
700 | 1 | |a Panzer, Falko |e investigator |4 oth | |
700 | 1 | |a Fuchs, Hans |e investigator |4 oth | |
700 | 1 | |a Dieks, Jana-Katharina |e investigator |4 oth | |
700 | 1 | |a Bauer, Martin Oliver |e investigator |4 oth | |
700 | 1 | |a Richter, Jost |e investigator |4 oth | |
700 | 1 | |a Biebach, Katrin |e investigator |4 oth | |
700 | 1 | |a Radowsky, Frank |e investigator |4 oth | |
700 | 1 | |a Donner, Matthias |e investigator |4 oth | |
700 | 1 | |a Denneberg, Katja |e investigator |4 oth | |
700 | 1 | |a Funck, Jurgen |e investigator |4 oth | |
700 | 1 | |a Westerholt, Soeren |e investigator |4 oth | |
700 | 1 | |a Horn, Michael |e investigator |4 oth | |
700 | 1 | |a Cremer, Malte |e investigator |4 oth | |
700 | 1 | |a Kamin, Wolfgang |e investigator |4 oth | |
700 | 1 | |a Schulze-Sturm, Ulf |e investigator |4 oth | |
700 | 1 | |a Konstantopoulos, Nikolaos |e investigator |4 oth | |
700 | 1 | |a Wilmsmeyer, Brigitte |e investigator |4 oth | |
700 | 1 | |a Voelkl, Thomas |e investigator |4 oth | |
700 | 1 | |a von Poblotzki, Martina |e investigator |4 oth | |
700 | 1 | |a Mueller, Andreas |e investigator |4 oth | |
700 | 1 | |a Leonhardt, Egbert |e investigator |4 oth | |
700 | 1 | |a Simmet, Siegfried |e investigator |4 oth | |
700 | 1 | |a Franke-Beckmann, Eivy |e investigator |4 oth | |
773 | 0 | 8 | |i Enthalten in |t The New England journal of medicine |d 1945 |g 389(2023), 26 vom: 28. Dez., Seite 2425-2435 |w (DE-627)NLM000008184 |x 1533-4406 |7 nnns |
773 | 1 | 8 | |g volume:389 |g year:2023 |g number:26 |g day:28 |g month:12 |g pages:2425-2435 |
856 | 4 | 0 | |u http://dx.doi.org/10.1056/NEJMoa2309189 |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a GBV_NLM | ||
951 | |a AR | ||
952 | |d 389 |j 2023 |e 26 |b 28 |c 12 |h 2425-2435 |