在多发性硬化症患者的ofatumumab暴露的母乳养中
Laura Witt1,2, Karen Dost-Kovalsky1, Natalia Friedmann1
1Department of Neurology, St. Josef-Hospital, Katholisches Klinikum Bochum, Ruhr-University Bochum, Bochum, Germany.
Multiple sclerosis (Houndmills, Basingstoke, England)
|January 6, 2025
概括
暴露于ofatumumab的母乳养对婴儿来说似乎是安全的,没有观察到对健康或发育的不良影响. 虽然ofatumumab转移到母乳中,但婴儿吸收风险很低.
科学领域:
- 免疫学 免疫学 免疫学
- 儿科 儿科 儿科
- 药理学 药理学是指药理学的学科.
背景情况:
- 在欧洲,Ofatumumab已被批准用于母乳养,但关于其转移到母乳中的数据和临床安全性有限.
- 在哺乳期间使用ofatumumab的临床经验有限.
研究的目的:
- 为了评估婴儿健康,发育,和不良事件后活体疫苗接种在ofatumumab暴露的母乳养婴儿.
- 用两种不同的方法来确定母乳中ofatumumab的检测能力,并计算相对婴儿剂量 (RID).
- 为了评估婴儿健康结果和母乳养期间ofatumumab转移.
主要方法:
- 通过标准化的电话采访收集临床数据的观察性研究,产后长达2年.
- 使用酶相关免疫吸收试验 (ELISA) 分析母乳样本以量化ofatumumab度.
- 使用传统方法和修改方法计算相对婴儿剂量 (RID),考虑母体多剂量和扩展采集.
主要成果:
- 十二名母亲母乳养的婴儿暴露于ofatumumab;没有婴儿显示健康,发育或B细胞水平的异常.
- 八名婴儿在暴露于ofatumumab的母乳养期间或之后接受了活疫苗,没有并发症.
- 母乳中的ofatumumab度各不相同,RID的中位数为0.027% (方法1) 和2.912% (方法2).
结论:
- 暴露于Ofatumumab的母乳养并没有对婴儿的健康或发育产生负面影响.
- 通过方法2计算的更高的RID表明婴儿对抗体大量吸收的风险较低.
- 奥法图马布似乎安全通过母乳供婴儿食用,支持其在哺乳期使用.
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