Terjung Birgit, Schmelz Renate, Ehehalt Robert, Klaus Jochen, Knop Jana, Schwind Sabine, Wilke Thomas, Stallmach Andreas
Department of Internal Medicine - Gastroenterology, GFO Kliniken Bonn, Nordrhein-Westfalen, Germany.
Medical Department 1, University Hospital Dresden, TU Dresden, Germany.
Therap Adv Gastroenterol. 2020 Oct 16;13:1756284820952592. doi: 10.1177/1756284820952592. eCollection 2020.
Crohn's disease (CD) and ulcerative colitis (UC) commonly affect women in their childbearing years. Vedolizumab (VDZ) is approved for treatment of moderate-to-severe CD and UC, but there is a knowledge gap regarding its use during pregnancy. This targeted literature review describes available evidence on safety of VDZ in pregnant patients in order to offer physicians a detailed and balanced view on persistent data during their decision-making process for an individualized treatment concept.
The search included literature from the MEDLINE database and abstracts of five gastroenterological conferences published until November 2019. Publications were included if pregnancy outcomes in women receiving VDZ or neonatal outcomes in newborns of women previously exposed to VDZ were reported.
Out of 196 initially identified records, 18 publications reporting results of five different studies were identified. In total, for 213 of 284 VDZ-exposed documented pregnancies the following pregnancy outcomes were reported: 167 live births (172 infants due to twin births), 1 stillbirth, 35 miscarriages, 10 elective terminations (1 due to detected Down syndrome). Furthermore, during pregnancy, the following complications were observed: seven cases of (pre) eclampsia, three cases of premature rupture of membranes and one case each of placenta previa, chorioamnionitis, pneumonia, first-trimester bleeding, cholestasis, sepsis, or neonatal intraventricular hemorrhage. Based on 172 infants, 30 preterm deliveries (17.4%), 9 cases of low birth weight (5.2%), 5 infections (2.9%), and 6 cases (3.8%) with congenital anomalies were reported.
There was no evidence for safety concerns regarding pregnancy outcomes associated with VDZ therapy. Due to the limited scope of included records, further research is needed to understand the safety profile regarding the use of VDZ during pregnancy.
克罗恩病（CD）和溃疡性结肠炎（UC）在育龄期女性中较为常见。维得利珠单抗（VDZ）已被批准用于治疗中重度CD和UC，但关于其在孕期的使用存在知识空白。这项针对性的文献综述描述了VDZ在孕妇中安全性的现有证据，以便在医生为个体化治疗方案进行决策时，为其提供关于现有数据的详细且平衡的观点。
检索包括MEDLINE数据库中的文献以及截至2019年11月发表的五个胃肠病学会议的摘要。如果报告了接受VDZ治疗的女性的妊娠结局或先前接触过VDZ的女性所生新生儿的结局，则纳入相关出版物。
在最初识别的196条记录中，确定了18篇报告五项不同研究结果的出版物。在284例有记录的VDZ暴露妊娠中，共213例报告了以下妊娠结局：167例活产（因双胞胎出生172例婴儿），1例死产，35例流产，10例选择性终止妊娠（1例因检测出唐氏综合征）。此外，孕期观察到以下并发症：7例（先兆）子痫，3例胎膜早破，前置胎盘、绒毛膜羊膜炎、肺炎、孕早期出血、胆汁淤积、败血症或新生儿脑室内出血各1例。基于172例婴儿，报告了30例早产（17.4%），9例低出生体重（5.2%），5例感染（2.9%），以及6例（3.8%）先天性异常。
没有证据表明VDZ治疗与妊娠结局存在安全性问题。由于纳入记录的范围有限，需要进一步研究以了解VDZ在孕期使用的安全性概况。
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