Clin Gastroenterology H: 粪钙卫蛋白水平和英夫利昔单抗的组合可确定患有克罗恩病的粘膜愈合情况

2020-02-23 不详 MedSci原创

本项研究根据内窥镜检查的结果,调查了是否可以将英夫利西单抗药代动力学和药效动力学监测的整合用于评估对英夫利昔单抗诱导和维持治疗的反应。

背景与目标
本项研究根据内窥镜检查的结果,调查了是否可以将英夫利西单抗药代动力学和药效动力学监测的整合用于评估对英夫利昔单抗诱导和维持治疗的反应。

方法
研究人员对一项包括在试验中的CD患者进行了事后分析,以测试英夫利昔单抗剂量升高的效果,该作用基于生物标志物和英夫利昔单抗的血清浓度对症状的影响,以确定生物标志物的浓度和英夫利昔单抗的血清浓度是否与内镜结果相关(n = 116)。主要终点为内镜治疗反应(CD内镜严重性指标较基线降低≥50%),内镜缓解(CD内镜严重性指标<3)以及英夫利昔单抗治疗第12周和第54周无溃疡情况。

结果
第2周时英夫利昔单抗谷浓度大于23.1 mg / L,第6周时大于10.0 mg / L与第12周内镜下缓解相关(阳性预测值分别为72%和76%;阴性预测值分别为65%和59% )。在维持治疗期间,仅在剂量增加后才发现暴露-反应关系的证据。在第54周,谷浓度高于10.6 mg / L与溃疡不存在有关(阳性预测值49%;阴性预测值92%)。治疗期间粪便中钙卫蛋白的浓度低与内镜反应和缓解有关(P<.05)。剂量增加会增加英夫利昔单抗的谷浓度。尽管剂量增加,钙卫蛋白的粪便浓度持续升高与缺乏内镜反应和缓解有关。与没有抗体的患者相比,通过药物耐受性分析鉴定出的具有抗英夫昔单抗抗体的患者比例明显更高(P <.0001)。

结论
本项发现在维持治疗期间,粪便中钙卫蛋白的浓度和英夫利昔单抗的谷浓度的组合可指导剂量调整并增加内镜检查的机会反应和缓解。

原始出处:

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    2020-12-18 许安
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    2020-12-29 guoyibin
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