Efficacy and safety of nirsevimab for preventing respiratory syncytial virus infection in infants: a meta-analysis
10.3760/cma.j.cn114015-20250219-00079
- VernacularTitle:尼塞韦单抗预防婴幼儿呼吸道合胞病毒感染有效性和安全性的meta分析
- Author:
Lin XU
1
;
Min MIAO
;
Yanlan ZHANG
;
Rui SONG
;
Caiying WANG
Author Information
1. 首都医科大学附属北京地坛医院儿科，北京 100015
- Publication Type:Journal Article
- Keywords:
Respiratory syncytial viruses;
Infant;
Chemoprovention;
Antibodies, monoclonal;
Nirsevimab;
Efficiency;
Safety;
Meta-analysis
- From:
Adverse Drug Reactions Journal
2025;27(9):537-544
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To systematically evaluate the efficacy and safety of nirsevimab in preventing respiratory syncytial virus (RSV) infection in infants.Methods:Randomized controlled trials (RCTs) of nirsevimab in the prevention of RSV infection in newborns and infants (≤ 2 years old) were collected by searching relevant databases at home and abroad (up to February 12, 2025). Subjects in the trial group received a single dose injection of nirsevimab, while those in the control group received placebo or no interventions, with an observation period of ≥150 days. The efficacy outcome indicators included the incidence of acute lower respiratory tract infections (LRTI), RSV-associated hospital visits, RSV-associated hospitalization, and severe RSV infection events. The safety outcome indicators were the occurrence of adverse events (AEs) after injection of nirsevimab. Quality of methodology was evaluated using bias risk assessment tool of Cochrane collaboration networks. Meta-analysis was performed using RevMan 5.4 software. The effect sizes were relative risk ( RR) and its 95% confidence interval ( CI). Results:A total of 4 RCTs and 11 051 subjects were entered in the analysis, including 6 032 subjects in the trial group and 5 019 in the control group. The results of meta-analysis showed that compared with the control group, the incidences of acute LRTI [4.94% (298/6 032) vs. 5.70% (286/5 019), RR=0.57, 95% CI: 0.41-0.81], RSV-associated hospital visits [1.85% (37/1 995) vs. 7.11% (71/998), RR=0.26, 95% CI: 0.18-0.38], RSV-associated hospitalization [0.31% (19/6 032) vs. 1.75% (88/5 019), RR=0.17, 95% CI: 0.07-0.43], and severe RSV infection events [0.10% (5/5 038) vs. 1.52% (69/4 523), RR=0.07, 95% CI: 0.03-0.17] in the trial group were significantly lower, and the differences were statistically significant (all P<0.001). The differences in incidences of AEs, grade ≥3 AEs, AEs of great concern, and death events in the 2 groups during the observation period were not significant (all P>0.05), and no nirsevimab-related death events occurred. Conclusion:Nirsevimab is effective in preventing RSV infection in infants and has a good safety profile.
