干扰素β暴露对出生结果和儿童发育的影响 - - 许可后安全性研究PRIMA的结果
Juliane Klehmet1, Yvonne Begus-Nahrmann2, Kirsi Taipale3
1Department of Neurology, Jüdisches Krankenhaus Berlin, Heinz-Galinski-Strasse 1, Berlin-Mitte 13347, Federal Republic of Germany.
Multiple sclerosis and related disorders
|July 2, 2023
概括
这项研究发现,用于多发性硬化症 (MS) 的干扰素β疗法在怀孕或母乳养期间不会对婴儿发育产生不利影响. 现实世界的数据支持这些治疗对患有多发性硬化症的母亲的安全性.
科学领域:
- 神经学 神经学
- 药物监督 药物监督 药物监督
- 生殖健康 生殖健康
背景情况:
- 干扰素β疗法是复发性多发性硬化症 (MS) 的已确立疾病修饰性治疗方法.
- 监管机构 (EMA,FDA) 根据临床证据在2019-2020年更新了干扰素β的怀孕和母乳养标签.
- 这项研究旨在收集现实世界,患者报告的数据,以补充这些标签更新.
研究的目的:
- 在怀孕和哺乳期间评估干扰素β-1a和肌内干扰素β-1a暴露的安全性.
- 评估这些疗法对48个月龄以下儿童发育的影响.
- 提供现实数据,支持干扰素β疗法在患有多发性硬化症的孕妇和哺乳妇女的安全性.
主要方法:
- 在许可后的PRIMA安全性研究中,加入了接受干扰素β-1a或IM干扰素β-1a治疗的MS患者.
- 从怀孕或在参加多发性硬化患者支持计划时怀孕的妇女收集了数据.
- 新生儿发育里程碑通过与母亲的电话采访来评估.
主要成果:
- 426名妇女报告有542例怀孕,导致466例活产.
- 新生儿表现出健康的Apgar分数,出生测量/生长曲线在德国人口的正常范围内.
- 婴儿查和检查在48个月之前基本上没有什么显著的; 70.9%的婴儿在前5个月内完全被母乳养.
结论:
- 在怀孕或哺乳期间暴露于干扰素β疗法,对子宫内生长或4岁以下儿童发育没有任何不良影响.
- 这些现实研究结果证实了注册数据,并支持对干扰素β疗法的更新安全标签.
- 这项研究加强了 peginterferon beta-1a 和 IM 干扰素 beta-1a 对怀孕或哺乳期的MS 妇女的安全性.
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