Biologic therapies in the context of inflammatory bowel disease and pregnancy lead to improved maternal and fetal outcomes. Placental transfer results in detectable drug concentrations in infants. Rotavirus infection results in diarrheal related hospitalizations; however, the live oral vaccine is not currently recommended in biologic exposed infants. The aim of this study was to assess the effect of maternal biologic therapies on the infant immune system and safety of live rotavirus vaccination in biologic-exposed infants. Biologic-exposed infants underwent standardized clinical assessments, drug concentration, and immune function testing (complete blood count, differential, immunoglobulin levels, extended B-cell and T-cell subset enumeration, Recent Thymic Emigrants, regulatory T-cell numbers, mitogen stimulation assays, and review of T-cell Receptor Excision Circles in the newborn screen). Rotavirus vaccine-specific adverse effects following immunizations up to 42 days post the last dose of the vaccine series were recorded. There were 57 infants born to 52 mothers with inflammatory bowel disease exposed to infliximab (n = 21), adalimumab (n = 19), vedolizumab (n = 10), and ustekinumab (n = 7) in the third trimester for a median of 39 weeks (interquartile range, 38–39 weeks) at delivery. Immunologic assessments validated for age were normal in all infants despite median infliximab concentrations of 6.1 ug/mL (range, 0.4–28.8 ug/mL), adalimumab concentrations of 1.7 ug/mL (range, 0.7–7.9 ug/mL), ustekinumab concentrations of 0.6 ug/mL (range, 0–1.1), and undetectable for vedolizumab at 10.7 weeks (interquartile range, 9.4–12.4) of age. The live oral rotavirus vaccine series was provided to 50 infants with the first dose given at a median of 13 weeks of age. No adverse effects following immunization were reported. Immune function testing was normal, and administration of live rotavirus vaccination appeared low-risk in biologic-exposed infants irrespective of circulating drug levels.

中文翻译：

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对于患有炎症性肠病的母亲所生的婴儿来说，轮状病毒活疫苗接种生物制剂的风险似乎较低


炎症性肠病和妊娠中的生物疗法可改善母婴结局。胎盘移植导致婴儿体内可检测到药物浓度。轮状病毒感染导致腹泻相关住院；然而，目前不建议对生物暴露的婴儿使用口服活疫苗。本研究的目的是评估母体生物疗法对婴儿免疫系统的影响以及暴露于生物制剂的婴儿活轮状病毒疫苗接种的安全性。生物暴露婴儿接受标准化临床评估、药物浓度和免疫功能测试（全血细胞计数、分类、免疫球蛋白水平、扩展的 B 细胞和 T 细胞子集计数、近期胸腺迁移、调节性 T 细胞数量、有丝分裂原刺激测定） ，以及新生儿筛查中 T 细胞受体切除圈的回顾）。记录最后一次接种疫苗系列后 42 天的免疫后轮状病毒疫苗特异性不良反应。 52 名患有炎症性肠病的母亲所生的 57 名婴儿在妊娠晚期接受了英夫利昔单抗 (n = 21)、阿达木单抗 (n = 19)、维多珠单抗 (n = 10) 和乌特克单抗 (n = 7) 的治疗，中位数为分娩时 39 周（四分位距，38-39 周）。尽管英夫利昔单抗浓度中位数为 6.1 ug/mL（范围，0.4-28.8 ug/mL）、阿达木单抗浓度为 1.7 ug/mL（范围，0.7-7.9 ug/mL）、优特克单抗浓度，但所有婴儿的年龄免疫学评估均正常。 0.6 ug/mL（范围，0–1.1），并且在 10.7 周（四分位范围，9.4–12.4）时维多珠单抗检测不到。向 50 名婴儿提供了口服轮状病毒活疫苗系列，第一剂在中位 13 周龄时接种。 没有报告免疫接种后的不良反应。免疫功能测试正常，无论循环药物水平如何，在生物暴露婴儿中接种活轮状病毒疫苗似乎风险较低。