Turalde-Mapili Maria Wilma R, Mapili Jerahmeel Aleson L, Turalde Christian Wilson R, Pagcatipunan Marimel R
Department of Pediatrics, College of Medicine, Philippine General Hospital, University of the Philippines Manila, Manila, Philippines.
Department of Medicine, College of Medicine, Philippine General Hospital, University of the Philippines Manila, Manila, Philippines.
Front Pediatr. 2023 Apr 4;11:1132740. doi: 10.3389/fped.2023.1132740. eCollection 2023.
Respiratory syncytial virus (RSV) is a leading cause of morbidity and mortality among infants with a global incidence of 9.5% and a mortality rate of 2.2%. The management of RSV infection is mainly supportive and, aside from emerging monoclonal antibodies, there has been no benefit of most preventive measures. Recent evidence suggests the potential of nirsevimab in preventing RSV infection.
This study aims to determine the efficacy and safety of nirsevimab in preventing RSV infection among infants using a review of relevant clinical trials.
We performed a random-effects meta-analysis among infants comparing nirsevimab injection vs. placebo. MEDLINE, CENTRAL, Scopus, and ClinicalTrials.gov were searched for relevant trials from inception to June 2022. The selected studies were assessed for risk of bias using the Revised Cochrane Risk-of-Bias (RoB2) tool and for quality of evidence using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.
Two studies were included. Data analysis showed that among infants, nirsevimab given before the RSV season significantly reduced the risk of medically attended RSV-related infection (RR: 0.26; 95% CI: 0.18-0.38) and the risk of hospitalization due to RSV infection (RR: 0.24; 95% CI: 0.13-0.47). There was no difference in terms of adverse events leading to death (RR: 0.78, 95% CI: 0.20-2.98) and adverse events of special interest (RR: 0.92, 95% CI: 0.25-3.38).
The use of nirsevimab to prevent RSV infections and hospitalization shows its promising potential, but studies on its cost-effectiveness are lacking. We recommend that further studies be done to look into the applicability and cost-effectiveness of nirsevimab.
呼吸道合胞病毒（RSV）是婴儿发病和死亡的主要原因，全球发病率为9.5%，死亡率为2.2%。RSV感染的治疗主要是支持性治疗，除了新出现的单克隆抗体外，大多数预防措施并无益处。最近的证据表明，尼塞韦单抗有预防RSV感染的潜力。
本研究旨在通过回顾相关临床试验，确定尼塞韦单抗预防婴儿RSV感染的疗效和安全性。
我们对婴儿进行了一项随机效应荟萃分析，比较尼塞韦单抗注射剂与安慰剂。检索了MEDLINE、CENTRAL、Scopus和ClinicalTrials.gov从创刊到2022年6月的相关试验。使用修订后的Cochrane偏倚风险（RoB2）工具评估所选研究的偏倚风险，并使用推荐分级、评估、制定和评价（GRADE）方法评估证据质量。
纳入两项研究。数据分析表明，在婴儿中，在RSV季节前给予尼塞韦单抗可显著降低因RSV相关感染就医的风险（RR：0.26；95%CI：0.18-0.38）以及因RSV感染住院的风险（RR：0.24；95%CI：0.13-0.47）。导致死亡的不良事件（RR：0.78，95%CI：0.20-2.98）和特别关注的不良事件（RR：0.92，95%CI：0.25-3.38）方面没有差异。
使用尼塞韦单抗预防RSV感染和住院显示出其有前景的潜力，但缺乏关于其成本效益的研究。我们建议进一步开展研究，以探讨尼塞韦单抗的适用性和成本效益。
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