Ocana de Sentuary Charlotte, Testard Clara, Lagrée Marion, Leroy Maxime, Gasnier Lisa, Enes-Dias Alicia, Leruste Constance, Diallo Diariatou, Génin Michael, Rakza Thameur, Dubos François
CHU Lille, Service de Pédiatrie de Maternité, Jeanne de Flandre Hospital, F-59000, Lille, France.
CHU Lille, Urgences Pédiatriques & Maladies Infectieuses, Roger Salengro Hospital, F-59000, Lille, France.
EClinicalMedicine. 2024 Dec 9;79:102986. doi: 10.1016/j.eclinm.2024.102986. eCollection 2025 Jan.
To evaluate the acceptance and safety of the treatment of newborns with nirsevimab (a long-acting monoclonal antibody designed to prevent respiratory syncytial virus infections) during the first season of implementation.
A longitudinal, prospective, single-centre cohort study was conducted from September 18th, 2023, to January 23rd, 2024 at Lille University Hospital (Lille, France). All newborns admitted to the hospital's maternity department during the study period and whose parents agreed to participate in the study were included. Parents were asked to state whether or not they agreed for their infant to receive nirsevimab. The occurrence of adverse events (AEs) 2 h after nirsevimab treatment and 7, 14 and 30 days after discharge was documented by the mother. The primary endpoint was the nirsevimab treatment acceptance rate. The secondary endpoints were the variables associated with the acceptance of nirsevimab, the reasons for accepting or refusing nirsevimab, and the treatment's real-life safety, relative to a non-treated control group of newborns.
Of the 1730 infants born in the hospital during the study period, 477 met all the inclusion criteria and were enrolled. The nirsevimab acceptance rate [95% confidence interval] was 91.6% [89.1%-94.2%]. In a multivariable analysis, the mother's age, lower parity and having a partner in work were significantly associated with nirsevimab acceptance. The most common reason for accepting treatment was "to protect my baby", and the most common reason for refusing treatment was the lack of long-term data on nirsevimab. The nirsevimab and control groups did not differ significantly in terms of the types and frequencies of AEs. At least one serious AE was reported for 9.4% of the infants in the nirsevimab group and for 10.3% in the control group. None of the serious AEs were considered to be related to nirsevimab treatment.
The nirsevimab acceptance rate for newborns in the maternity unit was high during the first season of implementation. The safety profile was very good, with no significant differences between the nirsevimab group and the control group.
None.
评估在实施的首个季节使用nirsevimab（一种旨在预防呼吸道合胞病毒感染的长效单克隆抗体）治疗新生儿的接受度和安全性。
于2023年9月18日至2024年1月23日在法国里尔大学医院（里尔）进行了一项纵向、前瞻性、单中心队列研究。纳入研究期间入住医院产科且其父母同意参与研究的所有新生儿。要求父母说明他们是否同意其婴儿接受nirsevimab治疗。母亲记录nirsevimab治疗后2小时以及出院后7天、14天和30天不良事件（AE）的发生情况。主要终点是nirsevimab治疗接受率。次要终点是与nirsevimab接受度相关的变量、接受或拒绝nirsevimab的原因以及相对于未治疗的新生儿对照组该治疗在实际应用中的安全性。
在研究期间医院出生的1730名婴儿中，477名符合所有纳入标准并被纳入研究。nirsevimab接受率[95%置信区间]为91.6%[89.1%-94.2%]。在多变量分析中，母亲年龄较小、低生育次数以及伴侣有工作与nirsevimab接受度显著相关。接受治疗最常见的原因是“保护我的宝宝”，拒绝治疗最常见的原因是缺乏nirsevimab的长期数据。nirsevimab组和对照组在AE的类型和频率方面无显著差异。nirsevimab组9.4%的婴儿和对照组10.3%的婴儿报告了至少一种严重AE。没有严重AE被认为与nirsevimab治疗有关。
在实施的首个季节，产科新生儿对nirsevimab的接受率较高。安全性非常好，nirsevimab组和对照组之间无显著差异。
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