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单次肌注Nirsevimab可有效预防早产儿呼吸道合胞病毒感染
2020-07-30 14:29

美国阿斯利康制药公司Tonya Villafana团队研究了单剂量Nirsevimab预防早产儿呼吸道合胞病毒的效果。2020年7月30日,该研究发表在《新英格兰医学杂志》上。

呼吸道合胞病毒(RSV)是婴儿下呼吸道感染的最常见原因,因此需在健康婴儿中预防RSV。Nirsevimab是一种具有延长半衰期的单克隆抗体,目前正在研发中,在整个RSV季中可通过单次肌注来保护婴儿。

在北半球和南半球进行的这项试验中,研究组评估了Nirsevimab对早产(妊娠29周0天至34周6天分娩)健康婴儿RSV相关下呼吸道感染的预防作用。2016年11月至2017年11月,研究组共招募了1453例早产婴儿,按2:1将其随机分组,其中969例在RSV季开始时接受单次肌注Nirsevimab,484例接受安慰剂。主要终点是给药150天后,与RSV相关的下呼吸道感染。

Nirsevimab组中经治疗的RSV相关下呼吸道感染的发生率为2.6%,显著低于安慰剂组(9.5%),发生率降低了70.1%。Nirsevimab组中RSV相关下呼吸道感染的住院率为0.8%,显著低于安慰剂组(4.1%),发生率降低了78.4%。这些差异在给药后的150天内以及不同地区和RSV亚型之间均保持一致。两个试验组的不良事件发生率相差不大,没有明显的超敏反应。

总之,对于健康早产婴儿,在RSV季单次肌注Nirsevimab,与安慰剂相比,可显著降低RSV相关的下呼吸道感染的发生率和住院率。

附:英文原文

Title: Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants

Author: M. Pamela Griffin, M.D.,, Yuan Yuan, Ph.D.,, Therese Takas, B.S.,, Joseph B. Domachowske, M.D.,, Shabir A. Madhi, M.B., B.Ch., Ph.D.,, Paolo Manzoni, M.D., Ph.D.,, Eric A.F. Simes, M.D.,, Mark T. Esser, Ph.D.,, Anis A. Khan, Ph.D.,, Filip Dubovsky, M.D.,, Tonya Villafana, Ph.D.,, and John P. DeVincenzo, M.D.

Issue&Volume: 2020-07-29

Abstract: BACKGROUND

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection in infants, and a need exists for prevention of RSV in healthy infants. Nirsevimab is a monoclonal antibody with an extended half-life that is being developed to protect infants for an entire RSV season with a single intramuscular dose.

METHODS

In this trial conducted in both northern and southern hemispheres, we evaluated nirsevimab for the prevention of RSV-associated lower respiratory tract infection in healthy infants who had been born preterm (29 weeks 0 days to 34 weeks 6 days of gestation). We randomly assigned the infants in a 2:1 ratio to receive nirsevimab, at a dose of 50 mg in a single intramuscular injection, or placebo at the start of an RSV season. The primary end point was medically attended RSV-associated lower respiratory tract infection through 150 days after administration of the dose. The secondary efficacy end point was hospitalization for RSV-associated lower respiratory tract infection through 150 days after administration of the dose.

RESULTS

From November 2016 through November 2017, a total of 1453 infants were randomly assigned to receive nirsevimab (969 infants) or placebo (484 infants) at the start of the RSV season. The incidence of medically attended RSV-associated lower respiratory tract infection was 70.1% lower (95% confidence interval [CI], 52.3 to 81.2) with nirsevimab prophylaxis than with placebo (2.6% [25 infants] vs. 9.5% [46 infants]; P<0.001) and the incidence of hospitalization for RSV-associated lower respiratory tract infection was 78.4% lower (95% CI, 51.9 to 90.3) with nirsevimab than with placebo (0.8% [8 infants] vs. 4.1% [20 infants]; P<0.001). These differences were consistent throughout the 150-day period after the dose was administered and across geographic locations and RSV subtypes. Adverse events were similar in the two trial groups, with no notable hypersensitivity reactions.

CONCLUSIONS

A single injection of nirsevimab resulted in fewer medically attended RSV-associated lower respiratory tract infections and hospitalizations than placebo throughout the RSV season in healthy preterm infants.

DOI: NJ202007303830509

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1913556

 

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home


本期文章:《新英格兰医学杂志》:Vol.383 No.5

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