Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Division of Gastroenterology, University of Toronto, Toronto, Ontario, Canada.
J Gastroenterol Hepatol. 2021 Oct;36(10):2640-2648. doi: 10.1111/jgh.15574. Epub 2021 Jun 22.
Vedolizumab is a novel monoclonal antibody used in patients with inflammatory bowel disease, often affecting women of child-bearing age. We aimed to compare maternal and fetal adverse outcomes in pregnancies of women with inflammatory bowel disease exposed to vedolizumab versus those on other treatment.
We performed a systematic literature search through December 2020 looking for studies including outcomes from pregnancies of female inflammatory bowel disease patients treated with vedolizumab. Our primary outcome was a composite of adverse pregnancy-related events in pregnancies of female patients on vedolizumab compared with those of disease-matched controls on other medication regimens. Events of interest included preterm births, early loss of pregnancy, late fetal death, elective termination of pregnancy, and congenital anomalies.
Four studies were included in our review meeting criteria for our primary analysis. Compared with those with no vedolizumab exposure, pregnancies with vedolizumab exposure had an increase in overall adverse pregnancy-related outcomes (odds ratio [OR] 2.18, 95% confidence interval [CI], 1.52-3.13). The vedolizumab group also had increased preterm births (OR 2.16, 95% CI, 1.28-3.66), and early loss of pregnancies (OR 1.79, 95% CI, 1.06-3.01) but no difference in number of live births (OR 0.60, 95%CI, 0.36-1.00), or congenital malformations (OR 1.56, 95% CI, 0.56-4.37).
Our systematic review highlights possible concern with the general safety of vedolizumab in pregnancy, as an increase in overall total unfavorable outcomes was observed. Premature births and early loss of pregnancy were also more prevalent in pregnant female patients on vedolizumab. It is possible these findings are confounded by disease activity, and further prospective cohort studies of vedolizumab and pregnancy outcomes are warranted.
Vedolizumab 是一种新型单克隆抗体，用于治疗炎症性肠病患者，这些患者常为育龄期女性。我们旨在比较接受Vedolizumab 治疗与接受其他治疗的炎症性肠病女性患者的母婴不良结局。
我们通过系统文献检索，检索截至 2020 年 12 月的研究，纳入了接受 Vedolizumab 治疗的女性炎症性肠病患者妊娠结局的研究。我们的主要结局是Vedolizumab 治疗组与其他药物治疗组疾病匹配对照相比，妊娠相关不良事件的综合复合结局。感兴趣的事件包括早产、妊娠早期丢失、晚期胎儿死亡、选择性终止妊娠和先天性畸形。
有 4 项研究符合我们主要分析的纳入标准。与Vedolizumab 暴露组相比，Vedolizumab 暴露组的总体妊娠相关不良结局增加（比值比 [OR] 2.18，95%置信区间 [CI]，1.52-3.13）。Vedolizumab 组的早产（OR 2.16，95%CI，1.28-3.66）和妊娠早期丢失（OR 1.79，95%CI，1.06-3.01）的发生率也更高，但活产（OR 0.60，95%CI，0.36-1.00）和先天性畸形（OR 1.56，95%CI，0.56-4.37）的发生率没有差异。
我们的系统综述强调了Vedolizumab 在妊娠期间的总体安全性可能令人担忧，因为观察到总体不良结局增加。Vedolizumab 治疗的妊娠女性早产和妊娠早期丢失更为常见。这些发现可能受到疾病活动度的影响，需要进一步进行前瞻性队列研究Vedolizumab 和妊娠结局。
