The Motherisk Program, Department of Clinical Pharmacology and Toxicology, The Hospital for Sick Children, University Ave 555, Toronto M5G 1X8, Canada.
Reprod Toxicol. 2011 Jul;32(1):93-7. doi: 10.1016/j.reprotox.2011.05.009. Epub 2011 May 20.
Infliximab is a chimeric IgG1 monoclonal antibody to tumor necrosis factor alpha (TNF)-α used in the treatment of inflammatory bowel disease and rheumatoid arthritis. Infliximab does not actively cross the placenta during the first trimester, but undergoes efficient placental transfer during the late second and third trimesters and is detectable in the infant's serum for several months after birth. This raises concerns about immunological risks of infection and response to vaccines. Available evidence from registry studies and case reports involving more than 300 pregnancy outcomes suggest that infliximab carries low fetal risk and is compatible with use during conception and the first two trimesters of pregnancy. The long-term effects of infliximab exposure on the developing immune system are yet unknown. Based on limited data from several case reports, infants born with detectable levels of infliximab do not seem to have an increased risk of infections in their first year of life and have normal responses to nonlive vaccines. However, a fatal case of disseminated mycobacterial infection has been reported in an infant who received BCG vaccine at 3 months of age, to a mother who had been treated with infliximab throughout her pregnancy. Vaccination with live viruses should be postponed in infants exposed to infliximab in utero, until serum levels are undetectable which may require more than 6 months. Discontinuing infliximab early in the third trimester should be considered in order to minimize late fetal exposure.
英夫利昔单抗是一种针对肿瘤坏死因子-α（TNF-α）的嵌合 IgG1 单克隆抗体，用于治疗炎症性肠病和类风湿关节炎。英夫利昔单抗在妊娠早期不会主动穿过胎盘，但在妊娠晚期的第二和第三个三个月期间会进行有效的胎盘转移，并在出生后几个月内可在婴儿的血清中检测到。这引发了对感染和疫苗反应的免疫风险的担忧。来自涉及 300 多个妊娠结局的注册研究和病例报告的现有证据表明，英夫利昔单抗对胎儿的风险较低，并且与妊娠期间和妊娠前三个月的使用兼容。英夫利昔单抗暴露对发育中免疫系统的长期影响尚不清楚。基于来自几个病例报告的有限数据，出生时可检测到英夫利昔单抗水平的婴儿在生命的第一年似乎没有增加感染的风险，并且对非活疫苗有正常的反应。然而，据报道，在一名婴儿中发生了致命的播散性分枝杆菌感染，该婴儿的母亲在整个怀孕期间接受了英夫利昔单抗治疗。在婴儿体内暴露于英夫利昔单抗的情况下，应推迟接种活病毒疫苗，直到血清水平无法检测到，这可能需要超过 6 个月的时间。应考虑在妊娠晚期尽早停用英夫利昔单抗，以尽量减少胎儿晚期暴露。
