McGill University, Montreal, Quebec, Canada, and Research Institute of the McGill University Health Center, McGill University, Montreal, Quebec, Canada.
Centre of Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada, and McGill University, Montreal, Quebec, Canada.
Arthritis Care Res (Hoboken). 2023 Apr;75(4):930-935. doi: 10.1002/acr.24813. Epub 2022 Nov 16.
Chronic inflammatory conditions, including inflammatory bowel diseases (IBD), psoriasis, and psoriatic arthritis, are prevalent among women of reproductive age; patients with active disease during pregnancy may be at an increased risk of adverse birth outcomes. For this reason, physicians are focused on approaches to controlling disease activity prior to and during pregnancy. The safety profile of many therapies used for these conditions has been relatively well established, though evidence on newer therapies is lacking. Ustekinumab is a relatively new interleukin-12/23 inhibitor approved for IBD, psoriasis, and psoriatic arthritis, whose safety in pregnancy is not yet fully understood. In this comprehensive review, we critically assess the available evidence on ustekinumab in pregnancy across animal studies and human case reports, case series, observational studies, and clinical practice guidelines. We show that, to date, studies have not identified an excess risk of adverse pregnancy outcomes among women exposed to ustekinumab in pregnancy, with few exposed pregnancies and potential for some bias. Clinical guidelines are conflicted regarding whether they recommend continuing or discontinuing ustekinumab, highlighting the paucity of data and need for more research on this issue.
慢性炎症性疾病，包括炎症性肠病（IBD）、银屑病和银屑病关节炎，在育龄妇女中较为常见；怀孕期间疾病活跃的患者可能面临不良生育结局的风险增加。出于这个原因，医生专注于在怀孕前和怀孕期间控制疾病活动的方法。许多用于这些疾病的治疗方法的安全性已得到相对充分的证实，尽管缺乏关于新疗法的证据。乌司奴单抗是一种新型的白细胞介素-12/23 抑制剂，已被批准用于治疗 IBD、银屑病和银屑病关节炎，但其在怀孕期间的安全性尚未完全了解。在这篇全面的综述中，我们批判性地评估了动物研究和人类病例报告、病例系列、观察性研究和临床实践指南中关于怀孕期间乌司奴单抗的现有证据。我们表明，迄今为止，研究并未发现暴露于乌司奴单抗的孕妇不良妊娠结局的风险增加，暴露于乌司奴单抗的妊娠次数较少，并且存在一些偏倚。临床指南在是否建议继续或停止使用乌司奴单抗方面存在冲突，这突出表明了数据的缺乏以及需要对此问题进行更多研究。
