單次肌注Nirsevimab可有效預防早產兒呼吸道合胞病毒感染
作者:
小柯機器人發布時間:2020/7/30 14:29:38
美國阿斯利康製藥公司Tonya Villafana團隊研究了單劑量Nirsevimab預防早產兒呼吸道合胞病毒的效果。2020年7月30日,該研究發表在《新英格蘭醫學雜誌》上。
呼吸道合胞病毒(RSV)是嬰兒下呼吸道感染的最常見原因,因此需在健康嬰兒中預防RSV。Nirsevimab是一種具有延長半衰期的單克隆抗體,目前正在研發中,在整個RSV季中可通過單次肌注來保護嬰兒。
在北半球和南半球進行的這項試驗中,研究組評估了Nirsevimab對早產(妊娠29周0天至34周6天分娩)健康嬰兒RSV相關下呼吸道感染的預防作用。2016年11月至2017年11月,研究組共招募了1453例早產嬰兒,按2:1將其隨機分組,其中969例在RSV季開始時接受單次肌注Nirsevimab,484例接受安慰劑。主要終點是給藥150天後,與RSV相關的下呼吸道感染。
Nirsevimab組中經治療的RSV相關下呼吸道感染的發生率為2.6%,顯著低於安慰劑組(9.5%),發生率降低了70.1%。Nirsevimab組中RSV相關下呼吸道感染的住院率為0.8%,顯著低於安慰劑組(4.1%),發生率降低了78.4%。這些差異在給藥後的150天內以及不同地區和RSV亞型之間均保持一致。兩個試驗組的不良事件發生率相差不大,沒有明顯的超敏反應。
總之,對於健康早產嬰兒,在RSV季單次肌注Nirsevimab,與安慰劑相比,可顯著降低RSV相關的下呼吸道感染的發生率和住院率。
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