{"id":21378,"date":"2022-03-11T05:17:00","date_gmt":"2022-03-10T21:17:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=21378"},"modified":"2022-03-11T06:44:21","modified_gmt":"2022-03-10T22:44:21","slug":"nejm%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9anirsevimab%e9%a2%84%e9%98%b2%e5%81%a5%e5%ba%b7%e7%9a%84%e6%99%9a%e6%9c%9f%e6%97%a9%e4%ba%a7%e5%84%bf%e5%8f%8a%e8%b6%b3%e6%9c%88%e4%ba%a7%e5%a9%b4","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=21378","title":{"rendered":"[NEJM\u53d1\u8868\u8bba\u6587]\uff1aNirsevimab\u9884\u9632\u5065\u5eb7\u7684\u665a\u671f\u65e9\u4ea7\u513f\u53ca\u8db3\u6708\u4ea7\u5a74\u513fRSV\u611f\u67d3"},"content":{"rendered":"\n

ORIGINAL ARTICLE<\/a>FREE PREVIEW<\/strong><\/p>\n\n\n\n

Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants<\/h1>\n\n\n\n

Laura L. Hammitt, Ron Dagan, Yuan Yuan,\u00a0et al<\/h3>\n\n\n\n

N Engl J Med 2022; 386:837-846
DOI: 10.1056\/NEJMoa2110275<\/h3>\n\n\n\n

Abstract<\/h2>\n\n\n\n

BACKGROUND<\/h3>\n\n\n\n

Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infection and hospitalization in infants. Nirsevimab is a monoclonal antibody to the RSV fusion protein that has an extended half-life. The efficacy and safety of nirsevimab in healthy late-preterm and term infants are uncertain.<\/p>\n\n\n\n

METHODS<\/h3>\n\n\n\n

<\/p>\n\n\n\n

We randomly assigned, in a 2:1 ratio, infants who had been born at a gestational age of at least 35 weeks to receive a single intramuscular injection of nirsevimab or placebo before the start of an RSV season. The primary efficacy end point was medically attended RSV-associated lower respiratory tract infection through 150 days after the injection. The secondary efficacy end point was hospitalization for RSV-associated lower respiratory tract infection through 150 days after the injection.<\/a><\/p>\n\n\n\n

RESULTS<\/h3>\n\n\n\n

A total of 1490 infants underwent randomization: 994 were assigned to the nirsevimab group and 496 to the placebo group. Medically attended RSV-associated lower respiratory tract infection occurred in 12 infants (1.2%) in the nirsevimab group and in 25 infants (5.0%) in the placebo group; these findings correspond to an efficacy of 74.5% (95% confidence interval [CI], 49.6 to 87.1; P<0.001) for nirsevimab. Hospitalization for RSV-associated lower respiratory tract infection occurred in 6 infants (0.6%) in the nirsevimab group and in 8 infants (1.6%) in the placebo group (efficacy, 62.1%; 95% CI, \u22128.6 to 86.8; P=0.07). Among infants with data available to day 361, antidrug antibodies after baseline were detected in 58 of 951 (6.1%) in the nirsevimab group and in 5 of 473 (1.1%) in the placebo group. Serious adverse events were reported in 67 of 987 infants (6.8%) who received nirsevimab and in 36 of 491 infants (7.3%) who received placebo.<\/p>\n\n\n\n

CONCLUSIONS<\/h3>\n\n\n\n

A single injection of nirsevimab administered before the RSV season protected healthy late-preterm and term infants from medically attended RSV-associated lower respiratory tract infection. (Funded by MedImmune\/AstraZeneca and Sanofi; MELODY ClinicalTrials.gov number, NCT03979313. opens in new tab<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"

ORIGINAL ARTICLEFREE PREVIEW Nirsevimab for Prevention […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21378"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21378"}],"version-history":[{"count":2,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21378\/revisions"}],"predecessor-version":[{"id":21439,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/21378\/revisions\/21439"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21378"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21378"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21378"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}