分析脐血中 TNF 抑制剂的水平，以验证 EULAR 关于 TNF 抑制剂在妊娠期间使用的注意事项。
Analysing cord blood levels of TNF inhibitors to validate the EULAR points to consider for TNF inhibitor use during pregnancy.
机构信息
Rheumatology, Erasmus Medical Center, Rotterdam, The Netherlands
FT1/GMB, Medicines Evaluation Board, Utrecht, The Netherlands.
出版信息
Ann Rheum Dis. 2022 Mar;81(3):402-405. doi: 10.1136/annrheumdis-2021-221036. Epub 2021 Sep 7.
BACKGROUND
To minimise placental transfer of tumour necrosis factor inhibitors (TNFi), the European League Against Rheumatism (EULAR) created points to consider (PtC) for the use of TNFi during pregnancy. We are the first to validate the EULAR-PtC by analysing TNFi concentrations in cord blood.
METHODS
Patients were derived from the Preconceptional Counselling in Active Rheumatoid Arthritis Study. TNFi was stopped at the time points recommended by the EULAR. Maternal blood and cord blood were collected and analysed for the concentration of TNFi.
RESULTS
111 patients were eligible for the analysis. Median stop time points were gestational age (GA) 37.0 weeks for certolizumab pegol, GA 25.0 weeks for etanercept, GA 19.0 weeks for adalimumab and GA 18.4 weeks for infliximab. Certolizumab pegol (n=68) was detectable in 5.9% of cord blood samples, with a median concentration of 0.3 µg/mL (IQR: 0.2-1.3) and a median cord/maternal concentration ratio of 0.010. Etanercept (n=30) was not detected in any cord blood samples. Adalimumab (n=25) was detectable in 48.0% of cord blood samples, with a median concentration of 0.5 µg/mL (IQR: 0.2-0.7) and a median concentration ratio of 0.062 (IQR: 0.018-0.15). Infliximab (n=14) was detectable in 57.1% of cord blood samples, with a median concentration of 0.4 µg/mL (IQR: 0.1-1.2) and a median concentration ratio of 0.012 (IQR: 0.006-0.081).
CONCLUSION
Compliance with the EULAR-PtC results in absence or low levels of TNFi in cord blood.
背景
为了将肿瘤坏死因子抑制剂（TNFi）在胎盘的转移减至最小，欧洲抗风湿病联盟（EULAR）制定了在妊娠期间使用 TNFi 的注意点（PtC）。我们是首个通过分析脐血中 TNFi 浓度来验证 EULAR-PtC 的。
方法
本研究的患者来源于主动型类风湿关节炎的孕前咨询研究。TNFi 在 EULAR 推荐的时间点停止使用。采集母亲和脐带血，分析 TNFi 的浓度。
结果
111 名患者符合分析条件。中值停药时间点为：培塞利珠单抗（certolizumab pegol）的妊娠周数（GA）37.0 周，依那西普（etanercept）的 GA 25.0 周，阿达木单抗（adalimumab）的 GA 19.0 周，英夫利昔单抗（infliximab）的 GA 18.4 周。在 5.9%的脐带血样本中可检测到培塞利珠单抗（n=68），中位数浓度为 0.3µg/mL（IQR：0.2-1.3），中位数脐带/母体浓度比为 0.010。没有检测到依那西普（n=30）在任何脐带血样本中。在 48.0%的脐带血样本中可检测到阿达木单抗（n=25），中位数浓度为 0.5µg/mL（IQR：0.2-0.7），中位数浓度比为 0.062（IQR：0.018-0.15）。在 57.1%的脐带血样本中可检测到英夫利昔单抗（n=14），中位数浓度为 0.4µg/mL（IQR：0.1-1.2），中位数浓度比为 0.012（IQR：0.006-0.081）。
结论
遵守 EULAR-PtC 可使 TNFi 在脐带血中无或低水平存在。
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