Department of Obstetrics and Gynecology, NYU Langone Health, NYU Langone Hospital Long Island, NYU Long Island School of Medicine, Mineola, NY, (Dr Rekawek).
Department of Obstetrics, Gynecology and Reproductive Science, Icahn School of Medicine at Mount Sinai, New York, NY, (Drs Johnson, Getrajdman, Roy-McMahon, and Mella).
Am J Obstet Gynecol MFM. 2022 Jan;4(1):100518. doi: 10.1016/j.ajogmf.2021.100518. Epub 2021 Oct 22.
There is growing evidence that biologic therapy is safe in pregnancies complicated by inflammatory bowel disease and that its use outweighs the risk of worsening disease activity, which is associated with adverse pregnancy outcomes. To our knowledge, there are limited data regarding the use of biologic therapy and the associated maternal adverse effects such as the risk of hypertensive outcomes, postoperative complications, and infectious risk.
Our objective was to evaluate a variety of obstetrical complications including maternal infectious outcomes, hypertensive outcomes, other adverse maternal outcomes including postoperative complications, venous thromboembolism, and postpartum hemorrhage; we also evaluated the neonatal outcomes associated with biologic use in pregnancies affected by inflammatory bowel disease.
This was a retrospective cohort study including patients with inflammatory bowel disease who were pregnant and delivered at our institution. The maternal demographics and the incidence of maternal and neonatal outcomes were compared among groups on the basis of biologic exposure using the chi-square or Fisher exact test for categorical variables and the t test or Mann-Whitney test for continuous variables. Multivariable logistic regression analysis was performed on composite outcomes adjusting for age, disease activity, maternal obesity, history of cesarean delivery, and history of corticosteroid use in pregnancy. The statistical significance was defined as P<.05.
A total of 322 patients who were pregnant, had inflammatory bowel disease, and delivered at our institution from 2012 to 2019, were included for analysis. Of these, 112 (34%) were on biologics during pregnancy. The patients in the biologic group had significantly lower body mass indices than the patients in the nonbiologic group (median body mass index, 22.4 vs 24.0, respectively; P=.04), and they were less likely to be multiparous (41% vs 59%, respectively; P=.003). In addition, more patients in the biologic group were likely to have Crohn disease with previous inflammatory bowel disease surgery (33% vs 20%, respectively; P=.01); otherwise, the 2 groups had similar baseline characteristics. Maternal infectious and hypertensive outcomes occurred significantly more frequently in the biologic group than the nonexposed group (22% vs 7%; P=.0003 and 19% vs 8%; P=.003, respectively). This remained statistically significant in multivariable logistic regression models. Specifically, maternal infectious and hypertensive outcomes occurred significantly more frequently in the patients on a single-agent antitumor necrosis factor treatment than the patients on no inflammatory bowel disease medication (24% vs 6%; P=.002; 22% vs 6%; P=.004), which remained statistically significant in multivariable logistic regression models. There was no difference in the neonatal adverse outcomes between the 2 groups.
Our data suggest an association between antepartum biologic use- specifically antitumor necrosis factor alpha therapy-and an increased risk of maternal infectious and hypertensive outcomes. This increased risk may be related to underlying disease activity and the same should be incorporated into a discussion with the patient. However, the discussion must be balanced with the important benefit of optimal disease control associated with biologic use in patients being treated for IBD.
越来越多的证据表明，生物制剂在炎症性肠病合并妊娠中是安全的，其使用的益处超过了疾病活动恶化的风险，因为疾病活动恶化与不良妊娠结局相关。据我们所知，关于生物制剂的使用以及与母体不良影响相关的资料有限，例如高血压结局、术后并发症和感染风险。
我们的目的是评估各种产科并发症，包括母体感染结局、高血压结局、其他母体不良结局，包括术后并发症、静脉血栓栓塞和产后出血；我们还评估了与炎症性肠病相关的生物制剂使用相关的新生儿结局。
这是一项回顾性队列研究，包括在我院妊娠并分娩的炎症性肠病患者。基于生物制剂暴露情况，使用卡方或 Fisher 确切检验比较各组的母体人口统计学和母婴结局发生率，并使用 t 检验或 Mann-Whitney 检验比较连续变量。对复合结局进行多变量逻辑回归分析，调整年龄、疾病活动、母体肥胖、剖宫产史和妊娠期间使用皮质类固醇的情况。统计显著性定义为 P<.05。
共有 322 名在我院妊娠并分娩的炎症性肠病患者纳入分析，其中 112 名（34%）在妊娠期间使用了生物制剂。生物制剂组的患者体重指数明显低于非生物制剂组（中位数体重指数分别为 22.4 与 24.0，P=.04），且多胎妊娠的可能性较小（分别为 41%与 59%，P=.003）。此外，生物制剂组更多的患者患有克罗恩病，且既往有炎症性肠病手术史（分别为 33%与 20%，P=.01）；除此之外，两组具有相似的基线特征。生物制剂组的母体感染和高血压结局发生率明显高于未暴露组（分别为 22%与 7%，P=.0003 和 19%与 8%，P=.003）。在多变量逻辑回归模型中，这仍然具有统计学意义。具体而言，与未接受炎症性肠病药物治疗的患者相比，接受单一抗肿瘤坏死因子治疗的患者发生母体感染和高血压结局的发生率明显更高（分别为 24%与 6%，P=.002；22%与 6%，P=.004），在多变量逻辑回归模型中，这仍然具有统计学意义。两组新生儿不良结局无差异。
我们的数据表明，产前使用生物制剂-特别是抗肿瘤坏死因子-α治疗-与母体感染和高血压结局风险增加相关。这种风险增加可能与潜在的疾病活动有关，在与患者讨论时应考虑到这一点。然而，必须在与接受炎症性肠病治疗的患者使用生物制剂相关的最佳疾病控制的重要益处之间进行平衡。
