Vasiliauskas Eric A, Church Joseph A, Silverman Neil, Barry Mary, Targan Stephan R, Dubinsky Marla C
Inflammatory Bowel Disease Center, Division of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, California 90048, USA.
Clin Gastroenterol Hepatol. 2006 Oct;4(10):1255-8. doi: 10.1016/j.cgh.2006.07.018.
BACKGROUND & AIMS: Control of Crohn's disease (CD) is important for conception and sustaining a pregnancy to term. Small series of infliximab use during pregnancy have reported favorable fetal and maternal outcomes. As a result of heightened maternal concern triggered by recent labeling changes, infliximab levels were measured in the newborn of a mother treated with infliximab.
Serum and breast milk infliximab levels were measured by enzyme-linked immunosorbent assay.
A 32-year-old woman with treatment-refractory CD continued infliximab therapy throughout pregnancy. Five infusions of infliximab, 10 mg/kg, the last one 2 weeks before delivery, successfully controlled her symptoms. Six weeks after delivery, the breast-fed infant's serum infliximab level was 39.5 microg/mL. Infliximab was not detected in the breast milk. Serial measurements revealed a continued slow decline of the infant's infliximab levels during the following 6 months, despite resumption of breast-feeding and subsequent retreatments of the mother with infliximab.
Clinically significant infliximab levels were detected in the offspring. High infliximab levels in the serum of this infant are likely due to placental transfer, not breast-feeding. Similar to other maternally acquired antibodies, the half-life of infliximab appears prolonged in newborns. The true short-term and long-term implications of exposure to infliximab during the newborn period are unknown. Patients and physicians must be informed about in utero exposure to infliximab and potentially other therapeutic antibodies. The timing of infusions to minimize antibody transfer to the fetus might be an important strategic consideration when therapeutic antibodies are used in pregnancy.
克罗恩病（CD）的病情控制对于受孕及维持妊娠至足月十分重要。少量关于孕期使用英夫利昔单抗的报道显示，胎儿及母体结局良好。由于近期药品标签变更引发了母亲们的高度关注，因此对一名接受英夫利昔单抗治疗的母亲所生新生儿的英夫利昔单抗水平进行了检测。
采用酶联免疫吸附测定法测量血清及母乳中的英夫利昔单抗水平。
一名32岁患有难治性CD的女性在整个孕期持续接受英夫利昔单抗治疗。共输注了5次英夫利昔单抗，剂量为10mg/kg，最后一次输注在分娩前2周，成功控制了她的症状。分娩6周后，母乳喂养婴儿的血清英夫利昔单抗水平为39.5μg/mL。母乳中未检测到英夫利昔单抗。连续测量显示，尽管母亲恢复母乳喂养且随后再次接受英夫利昔单抗治疗，但婴儿的英夫利昔单抗水平在接下来的6个月中持续缓慢下降。
在该名后代中检测到具有临床意义的英夫利昔单抗水平。该婴儿血清中英夫利昔单抗水平较高可能是由于胎盘转运，而非母乳喂养。与其他母体获得性抗体类似，英夫利昔单抗在新生儿中的半衰期似乎延长。新生儿期接触英夫利昔单抗的真正短期和长期影响尚不清楚。必须告知患者和医生胎儿在子宫内接触英夫利昔单抗及可能接触其他治疗性抗体的情况。当孕期使用治疗性抗体时，为尽量减少抗体向胎儿的转移而进行输注的时机可能是一个重要的策略性考虑因素。
