尼舍单抗对婴儿呼吸道合胞病毒的疗效及相关事件

IF 5.8 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology Pub Date : 2024-11-01 DOI:10.1016/j.anai.2024.10.008

A. Hsiao , J. Hansen , J. Timbol , B. Fireman , O. Zerbo , K. Mari , C. Rizzo , W. La Via , R. Izikson , N. Klein

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引用次数: 0

摘要

背景美国疾病控制和预防中心推荐婴儿使用nirsevimab来预防呼吸道合胞病毒（RSV）疾病，这是下呼吸道疾病（LRTD）最常见的病因。之前公布的 nirsevimab 疗效仅限于医院环境。本研究评估了 nirsevimab 在 2023 年至 2024 年期间在综合医疗保健服务系统的所有环境中对 RSV、LRTD 和相关医疗事件的有效性。我们纳入了 2023 年 4 月或以后出生的健康足月婴儿，但排除了患有高风险疾病或母亲接种过 RSV 疫苗的婴儿。主要终点是根据国际疾病分类第十版代码在任何情况下诊断出聚合酶链反应阳性的 RSV LRTD。通过 Cox 回归评估了 Nirsevimab 对 RSV LRTD 的有效性，估计值为（1-危险比）。我们通过线性回归估算了尼尔赛维单抗治疗与每次发病的平均就诊次数之间的关系，并通过逻辑回归估算了住院几率。在接受过尼舍维单抗治疗的婴儿中，RSV LRTD发作次数为35次（6.1/1000人-年），而在未接受过尼舍维单抗治疗的婴儿中，RSV LRTD发作次数为462次（58.5/1000人-年）。调整后的尼尔赛维单抗对 RSV LRTD 的有效性估计值为 87.2%（CI：81.7%-91.1%）。结论在这项大型研究中，在所有医疗机构中，尼舍单抗可将RSV LRTD的风险降低87%。与未接受治疗的婴儿相比，使用尼尔赛维单抗后出现 RSV LRTD 的婴儿就医次数明显减少，住院的可能性也更低。

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Effectiveness of nirsevimab in infants against respiratory syncytial virus and related events

Background

Nirsevimab is Centers for Disease Control and Prevention–recommended for infants to prevent respiratory syncytial virus (RSV) disease, the most common cause of lower respiratory tract disease (LRTD). Previously published nirsevimab effectiveness has been limited to the hospital setting. This study assessed nirsevimab's effectiveness against RSV, LRTD, and associated medical encounters across all settings in an integrated healthcare delivery system between 2023 and 2024.

Methods

Nirsevimab administration started on October 19, 2023. We included healthy-term infants born in April 2023 or later and excluded infants with high-risk conditions or whose mothers were RSV-vaccinated. The primary endpoint was a polymerase chain reaction positive RSV LRTD diagnosis by the International Classification of Diseases, 10th Revision code in any setting. Nirsevimab effectiveness against RSV LRTD was assessed by Cox regression and estimated as (1-hazard ratio). We estimated the association of nirsevimab treatment with the mean number of encounters per episode by linear regression and the odds of hospitalization by logistic regression.

Results

The study included 31,900 infants; 15,647 of whom received nirsevimab. There were 35 RSV LRTD episodes (6.1/1000 person-years) among nirsevimab-treated infants compared with 462 episodes (58.5/1000 person-years) among untreated infants. The adjusted nirsevimab effectiveness estimate against RSV LRTD was 87.2% (CI: 81.7%-91.1%). Nirsevimab-treated infants with RSV LRTD had a lower mean number of encounters (2.1 vs 2.7, P = .001) and lower hospitalization odds (odds ratio = 0.11, CI: 0.01-0.85).

Conclusion

In this large study, nirsevimab reduced the risk of RSV LRTD by 87% across all healthcare settings. Compared with untreated infants, those who had RSV LRTD after nirsevimab had significantly fewer medical encounters and were less likely to be hospitalized.

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来源期刊

Annals of Allergy Asthma & Immunology 医学-过敏

CiteScore

6.50

自引率

6.80%

发文量

437

审稿时长

33 days

期刊介绍： Annals of Allergy, Asthma & Immunology is a scholarly medical journal published monthly by the American College of Allergy, Asthma & Immunology. The purpose of Annals is to serve as an objective evidence-based forum for the allergy/immunology specialist to keep up to date on current clinical science (both research and practice-based) in the fields of allergy, asthma, and immunology. The emphasis of the journal will be to provide clinical and research information that is readily applicable to both the clinician and the researcher. Each issue of the Annals shall also provide opportunities to participate in accredited continuing medical education activities to enhance overall clinical proficiency.