杜皮卢马布没有显示增加孕产妇不良妊娠结果的风险:一项倾向匹配的队列研究
Sophie L Preuß1, Katja Bieber2, Artem Vorobyev1
1Department of Dermatology, University Medical Centre of the State of Schleswig-Holstein (UKSH), Lübeck, Germany.
概括
在怀孕期间对2型慢性炎症性疾病 (T2IDs) 治疗dupilumab显示出良好的安全性,没有增加不良妊娠结果 (APOs) 的风险. 这项现实研究发现,在接受治疗的妇女中,早产和整体APO的风险降低了.
科学领域:
- 免疫学 免疫学 免疫学
- 生殖健康 生殖健康
- 药理学 药理学是指药理学的学科.
背景情况:
- 2型慢性炎症性疾病 (T2IDs) 影响了许多生育年龄的女性.
- 单克隆抗体杜皮卢马布 (Dupilumab) 越来越多地用于T2ID,但未经FDA批准在怀孕期间使用.
- 目前关于dupilumab在怀孕期间的安全性数据有限,需要进一步调查.
研究的目的:
- 为了回顾评估怀孕后不良结果 (APOs) 的风险,在怀孕妇女与T2IDs治疗dupilumab.
- 为了比较dupilumab暴露的孕妇的APO与T2IDs未经治疗的妇女的倾向性得分匹配队列.
主要方法:
- 使用美国TriNetX网络进行的一项回顾性队列研究.
- 倾向性得分匹配 (PSM) 用于控制杜皮卢马布治疗和未治疗的T2ID孕妇之间的混因素.
- 分析包括母亲的并发症,如早产,妊娠引起的高血压,妊娠期糖尿病,产后感染和自发流产.
主要成果:
- 确定了293名暴露于杜皮卢马布的孕妇.
- 在PSM之后,没有观察到任何不良妊娠结果 (APO) 的风险增加.
- 杜皮卢马布治疗与早产妇分娩 (HR:0.11) 和任何APO (HR:0.53) 的风险降低有关.
结论:
- 这项大规模的,倾向匹配的研究表明,dupilumab在怀孕期间对患有T2ID的妇女具有有利的安全性.
- 这些发现提供了有价值的现实世界的证据,解决了潜在怀孕研究的局限性.
- 建议进行进一步的研究来证实这些安全性发现,并探索潜在的因果关系.
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