Division of Research, Vaccine Study Center, Kaiser Permanente Northern California, Oakland, California.
Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.
Pediatrics. 2022 Jul 1;150(1). doi: 10.1542/peds.2021-056021.
: To estimate the prevalence of biological response modifiers (BRM) use during pregnancy and compare clinical outcomes in infants, live-attenuated immunization coverage and adverse events of special interest (AESI) following immunization.
: We conducted a retrospective cohort study among pregnant people between 2006 – 2017 and children born from these pregnancies within the Vaccine Safety Datalink. We estimated the proportion of women who used BRM during pregnancy overall and by year of pregnancy onset. We compared clinical outcomes, live-attenuated vaccination coverage, and AESI occurring in specific risk intervals following immunization in children exposed and unexposed in utero to BRM.
: Of the 1,205,416 pregnant people, 2,243 used BRM (19/10,000), which increased from 8/10,000 in 2006 to 46/10,000 pregnant people in 2017. The most frequently dispensed or prescribed BRM were etanercept (35.9%), anakinra (23.2%), adalimumab (21.4%) and infliximab (19.9%). Except for pneumonia, clinical outcomes of interest were rare among exposed and unexposed children to BRM. Proportions of clinical outcomes were similar between both groups. A lower proportion of children exposed to BRM receive rotavirus vaccines by age 12 months compared with unexposed children (79.5% vs. 85.4%). AESI with measles-containing vaccines or rotavirus vaccines were rare and proportions of these were similar among exposed and unexposed children.
: In utero exposure to BRM was not associated with an increased risk of clinically significant infections or adverse events following live-attenuated vaccines. These data provide reassurance that children exposed in utero to BRM can receive live-attenuated vaccines on the same schedule as other children.
估计妊娠期间生物反应调节剂（BRM）的使用情况，并比较婴儿的临床结局、活疫苗接种覆盖率以及接种后的特殊关注不良事件（AESI）。
我们对 2006 年至 2017 年间的孕妇以及这些孕妇所生孩子进行了回顾性队列研究，研究对象来自疫苗安全数据链。我们估计了妊娠期间整体以及每年妊娠开始时使用 BRM 的孕妇比例。我们比较了在 BRM 宫内暴露和未暴露的儿童中，接种活疫苗后特定风险间隔内的临床结局、活疫苗接种覆盖率和 AESI。
在 1205416 名孕妇中，有 2243 名（19/10000）使用了 BRM，从 2006 年的 8/10000 增加到 2017 年的 46/10000 名孕妇。使用最频繁的 BRM 是依那西普（35.9%）、阿那白滞素（23.2%）、阿达木单抗（21.4%）和英夫利昔单抗（19.9%）。除肺炎外，BRM 宫内暴露和未暴露的儿童中，感兴趣的临床结局均很少见。两组间的临床结局比例相似。BRM 宫内暴露的儿童在 12 个月时接受轮状病毒疫苗的比例低于未暴露的儿童（79.5% vs. 85.4%）。麻疹疫苗或轮状病毒疫苗的 AESI 很少见，暴露组和未暴露组的比例相似。
BRM 宫内暴露与活疫苗接种后发生临床显著感染或不良事件的风险增加无关。这些数据提供了保证，即 BRM 宫内暴露的儿童可以按照与其他儿童相同的时间表接种活疫苗。
