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AP&T: Vedolizumab血清浓度与溃疡性结肠炎的临床结果之间的关系

2019-02-16 不详 MedSci原创

维多珠单抗(Vedolizumab)在治疗溃疡性结肠炎中前景广阔,治疗效果优良。但是目前缺乏前瞻性设计来评估维多珠单抗暴露浓度与疗效反应之间的研究。因此本项研究的主要目的是(a)调整潜在混杂变量后调查维多珠单抗暴露 - 反应关系; (b)提出潜在的目标血清维多珠单抗浓度用于未来的研究; (c)确定早期维多珠单抗血清浓度是否溃疡性结肠炎短期和长期临床结果相关。

背景
维多珠单抗(Vedolizumab)在治疗溃疡性结肠炎中前景广阔,治疗效果优良。但是目前缺乏前瞻性设计来评估维多珠单抗暴露浓度与疗效反应之间的研究。因此本项研究的主要目的是(a)调整潜在混杂变量后调查维多珠单抗暴露 - 反应关系; (b)提出潜在的目标血清维多珠单抗浓度用于未来的研究; (c)确定早期维多珠单抗血清浓度是否溃疡性结肠炎短期和长期临床结果相关。

方法
研究人员使用来自GEMINI 1和早期大群体药代动力学研究的数据进行基于倾向评分的病例匹配分析,其中维多珠单抗清除率或浓度作为临床缓解和反应的预测因子,根据年龄,体重,抗肿瘤坏死因子α疗法进行调整病史,血清白蛋白和粪便钙卫蛋白浓度。并测量了第6周,第14周的维多珠单抗浓度。并评估第2,4和6周时早期维多珠单抗浓度与第14周和第52周临床缓解之间的关联。

结果
结果显示在693名有药代动力学数据患者中,第6,14周的目标维多珠单抗浓度分别为37.1,18.4和12.7μg/ mL。第6周被确定为维多利珠单抗浓度在第14周和第52周始终与临床缓解相关的最早时间。

结论
本项研究表明第6周的维多珠单抗浓度与短期和长期缓解相关,最佳浓度为37.1μg/ mL。

原始出处:

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    2019-11-02 nymo
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    2019-08-14 snf701207
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