Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
Am J Gastroenterol. 2018 Nov;113(11):1592-1593. doi: 10.1038/s41395-018-0372-5. Epub 2018 Oct 17.
Infliximab was the first FDA approved biologic for the treatment of Crohn's disease. Data for its use before and during pregnancy in both females and males have been increasing over the last decade, but most studies have had fewer than 100 patients and inconsistent comparison to healthy control outcomes. New data from the TREAT Safety Registry have a robust N of female and male patients exposed to infliximab with known birth outcomes from both academic and community settings. There does not appear to be any increase in adverse pregnancy outcomes from this population.
英夫利昔单抗是首个获得美国食品药品监督管理局批准用于治疗克罗恩病的生物制剂。在过去十年中，有关其在女性和男性中妊娠前和妊娠期间使用的数据一直在增加，但大多数研究的患者人数都少于 100 人，并且与健康对照组的结果不一致。来自 TREAT 安全性注册研究的新数据显示，在学术和社区环境中，有大量接受英夫利昔单抗治疗且已知有生育结局的女性和男性患者。来自该人群的不良妊娠结局似乎没有增加。
