一个Upadacitinib对巨细胞动脉炎的第三阶段试验
Daniel Blockmans1,2, Sara K Penn3, Arathi R Setty3
1Department of General Internal Medicine, University Hospitals Leuven, Leuven, Belgium.
The New England journal of medicine
|April 2, 2025
概括
与安慰剂相比,upadacitinib 15 mg在实现巨细胞动脉炎持续缓解方面表现出更高的疗效. 服用7.5毫克的剂量并没有显著改善,尽管安全性概况在各组之间是可比的.
科学领域:
- 类风湿病学 类风湿病学
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 巨细胞动脉炎 (GCA) 是一种全身性血管炎,治疗选择有限.
- 乌帕达西尼布是一种选择性的简氏激酶 (JAK) 抑制剂,向关键的炎症性细胞因子.
- 在GCA患者中,upadacitinib的疗效和安全性以前是未知的.
研究的目的:
- 评估乌帕达西提尼布在患有巨细胞动脉炎的患者中的疗效和安全性.
- 为了在GCA治疗中比较upadacitinib (15 mg和7.5 mg) 与安慰剂.
- 评估持续缓解率和其他临床结果.
主要方法:
- 进行了一项随机,双盲,安慰剂对照试验 (SELECT-GCA).
- 患者接受了乌帕达西提尼布 (每天15毫克或7.5毫克) 随着26周的葡萄糖皮质类药物逐渐减少或安慰剂随着52周的逐渐减少.
- 主要终点是52周持续缓解.
主要成果:
- 在实现持续缓解方面,Upadacitinib 15 mg显著优于安慰剂 (46.4%对29.0%,P=0.002).
- 15毫克的剂量也显示在二次终点上的优越性,包括缓解,爆发预防和患者报告的结果.
- 乌帕达西提尼布7.5毫克没有达到主要终点;安全结果在所有组中都是相似的,没有报告重大心血管不良事件.
结论:
- 乌帕达西丁15毫克,结合26周的葡萄糖皮质激素逐渐减少,是巨细胞动脉炎的有效治疗方法.
- 没有发现7.5毫克的阿帕达西提尼布剂量在持续缓解方面优于安慰剂.
- 乌帕达西提尼布为GCA患者提供了一个有前途的治疗选择,具有可管理的安全性.
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