来自所有关键随机临床试验的婴儿和儿童的nirsevimab安全数据的综合摘要
Vaishali S Mankad1, Amanda Leach2, Yue Chang2
1Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Durham, NC 27703, USA.
Pathogens (Basel, Switzerland)
|June 26, 2024
概括
尼尔塞维马布在预防呼吸道同胞病毒 (RSV) 感染婴儿下呼吸道疾病方面表现出良好的安全性. 不良事件的发生率在尼尔塞维玛布,安慰剂和帕利维祖马布治疗中是相似的.
科学领域:
- 儿科 儿科 儿科
- 免疫学 免疫学 免疫学
- 传染性疾病 传染性疾病
背景情况:
- 尼尔西维玛 (Nirsevimab) 已批准用于预防新生儿和婴儿的呼吸道同胞病毒 (RSV) 下呼吸道疾病.
- 它适用于RSV第一季的婴儿和最多24个月的易受感染的儿童.
- 本分析重点是从三个关键临床试验中获得的nirsevimab安全数据.
研究的目的:
- 评估nirsevimab在预防RSV下呼吸道疾病方面的安全性.
- 分析三项随机对照试验预先规定的安全数据.
主要方法:
- 从三项试验汇总了数据:第2b期,第3期MELODY和第2/3期MEDLEY.
- 参与者接受了单次肌肉内注射剂量尼尔塞维马布或比较剂 (安慰剂或帕利维祖马布).
- 剂量因婴儿体重和妊娠年龄而异,一些MEDLEY参与者继续进入第二个RSV季节.
主要成果:
- 在nirsevimab,安慰剂和palivizumab组中,不良事件 (AEs) 在发生率,严重程度和性质上相似.
- 绝大多数AEs (≥98%) 是轻度至中度,与治疗无关.
- 特别感兴趣的副作用,包括过敏反应,血小板减少和免疫复杂性疾病,是罕见的,与治疗无关. 死亡也与治疗无关.
结论:
- 一次性季节性尼尔塞维马布剂量在预防RSV疾病方面表现出良好的安全性.
- 无论婴儿的妊娠年龄或伴随疾病的存在,安全概况都是一致的.
- 尼尔西维玛为保护婴儿免受严重的RSV疾病提供了一个安全的选择.
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