Department of Rheumatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Medicines Evaluation Board (MEB), Graadt van Roggenweg 500, 3531 AH, Utrecht, The Netherlands.
Drugs. 2020 Nov;80(16):1699-1722. doi: 10.1007/s40265-020-01376-y.
Inflammatory autoimmune diseases are chronic diseases that often affect women of childbearing age. Therefore, detailed knowledge of the safety profile of medications used for management of inflammatory autoimmune diseases during pregnancy is important. However, in many cases the potential harmful effects of medications (especially biologics) during pregnancy (and lactation) on mother and child have not been fully identified.
Our aim was to update the data on the occurrence of miscarriages and (major) congenital malformations when using biologics during pregnancy based on newly published articles. Additionally, we selected several different secondary outcomes that may be of interest for clinicians, especially information on adverse events in the use of a specific biologic during pregnancy.
A search was conducted from 1 January 2015 until 4 July 2019 in Embase.com, Medline Ovid, Web of Science, Cochrane CENTRAL, and Google Scholar with specific search terms for each database. Selection of publications was based on title/abstract and followed by full text (double blinded, two researchers). An overview was made based on outcomes of interest. References of the included publications were reviewed to include and minimize the missing publications.
A total of 143 publications were included. The total number of cases ranged from nine for canakinumab to 4276 for infliximab. The rates of miscarriages and major congenital malformations did not show relevant differences from those rates in the general population.
Despite limitations to our study, no major safety issues were reported and no trend could be identified in the reported malformations.
炎症性自身免疫性疾病是慢性疾病，常影响育龄妇女。因此，详细了解用于治疗炎症性自身免疫性疾病的药物在怀孕期间的安全性概况非常重要。然而，在许多情况下，药物（尤其是生物制剂）在怀孕期间（和哺乳期）对母婴的潜在有害影响尚未完全确定。
我们旨在根据新发表的文章更新使用生物制剂治疗期间发生流产和（主要）先天性畸形的数据。此外，我们选择了几个可能对临床医生感兴趣的次要结果，特别是在怀孕期间使用特定生物制剂时的不良事件信息。
从 2015 年 1 月 1 日至 2019 年 7 月 4 日，在 Embase.com、Medline Ovid、Web of Science、Cochrane CENTRAL 和 Google Scholar 中使用特定的搜索词进行了搜索。出版物的选择基于标题/摘要，然后是全文（双盲，两名研究人员）。根据感兴趣的结果进行了概述。审查了纳入出版物的参考文献，以包括和尽量减少缺失的出版物。
共纳入 143 篇出版物。流产和主要先天性畸形的总病例数从卡那单抗的 9 例到英夫利昔单抗的 4276 例不等。流产率和主要先天性畸形率与一般人群的比率没有明显差异。
尽管我们的研究存在局限性，但没有报告重大安全问题，也没有发现报告的畸形有任何趋势。
