怀孕和婴儿结局在多发性硬化症妇女治疗ocrelizumab治疗
Sandra Vukusic1,2,3,4, Riley Bove5, Ruth Dobson6
1Service de Neurologie, Hospices Civils de Lyon, Bron.
Neurology(R) neuroimmunology & neuroinflammation
|December 17, 2024
概括
在多发性硬化症 (MS) 中,ocrelizumab (抗CD20) 与增加妊娠或婴儿不良结果无关. 这些发现支持接受ocrelizumab治疗的MS妇女的知情计划生育.
科学领域:
- 神经免疫学 神经免疫学
- 生殖健康 生殖健康
- 药物监督 药物监督 药物监督
背景情况:
- 奥克雷利祖马布是一种针对多发性硬化症 (MS) 的抗CD20疗法.
- 由于潜在的风险,目前的指导方针建议在ocrelizumab治疗期间和治疗后6-12个月内避孕.
- 了解在暴露于ocrelizumab后怀孕和婴儿的结果对于计划生育决策至关重要.
研究的目的:
- 评估患有多发性硬化症 (MS) 的妇女暴露于ocrelizumab的妊娠和婴儿后果.
- 为MS患者接受ocrelizumab治疗的妇女提供有关计划生育的知情决策的数据.
主要方法:
- 分析报告给全球药监监管的怀孕病例 (直到2023年7月).
- 在子宫内暴露被定义为在最后一次月经或怀孕期间的3个月内输注ocrelizumab.
- 在暴露于ocrelizumab和未暴露的怀孕之间比较结果 (活产,自发流产,死产,早产,重大先天异常).
主要成果:
- 在接受ocrelizumab的MS妇女中报告了3,244例怀孕;母亲的中位数年龄为32岁,复发性MS的65.6%.
- 在前性报告的2,444例怀孕中,有855例在子宫内暴露.
- 活产率相似 (84.2%暴露与88.3%不暴露);在暴露组中没有发现重大先天性异常,自发性流产或早产的风险增加.
结论:
- 患有MS的妇女在子宫内接触ocrelizumab并没有增加妊娠或婴儿不良后果的风险.
- 这些发现可以帮助神经科医生和患者做出明智的计划生育选择.
- 均衡疾病控制与胎儿/婴儿安全是MS妇女考虑怀孕在ocrelizumab治疗期间的关键.
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