在早期多发性肌痛风湿症 (BACHELOR) 中使用巴里西提尼布:一个随机,双盲,安慰剂控制,并行组试验
Alain Saraux1, Guillermo Carvajal Alegria2, Emmanuelle Dernis3
1Department of Rheumatology, Université de Bretagne Occidentale, CHU Brest, INSERM (U1227), LabEx IGO Brest, France.
The Lancet. Rheumatology
|January 16, 2025
概括
在一项临床试验中,巴里西替尼 (baricitinib) 有效控制了多发性肌痛性风湿症 (PMR) 症状,显著减少了口服葡萄糖皮质类药物的需要. 这种Janus激酶抑制剂在没有新的安全问题的情况下显示出对PMR治疗的希望.
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:
- 葡萄糖皮质类药物可以改善多发性肌痛性风湿症 (PMR),但在老年人中会引起不良事件.
- 巴里西提尼布是一种Janus激酶 (JAK) 1/2抑制剂,被研究用于PMR治疗.
- 这项研究的重点是最近出现的PMR患者,他们没有接受过葡萄糖皮质醇.
研究的目的:
- 评估巴里西提尼布在没有口服葡萄糖皮质类药物的情况下实现疾病控制的疗效,在最近出现的PMR中.
- 评估巴里西提尼布在这个患者群体中的安全性.
主要方法:
- 一项随机,双盲,安慰剂对照试验在法国六个中心进行.
- 参与者接受了4毫克巴里西提尼布或安慰剂12周,然后再接受2毫克12周.
- 主要结局是12周的C-反应蛋白PMR活性得分 (CRP PMR-AS) 不使用口服葡萄糖皮质激素时为10或以下.
主要成果:
- 服用巴里西提尼布的78%的参与者实现了主要终点,而安慰剂的13% (相对风险5.8,p<0.0001).
- 肌肉骨和结缔组织疾病是最常见的不良事件.
- 在这两组中都没有报告死亡或重大心血管不良事件.
结论:
- 与安慰剂相比,巴里西提尼布 (4毫克) 在12周内在不需要口服葡萄糖皮质类药物的情况下实现低疾病活性方面表现出更高的疗效.
- 治疗没有显示出新的安全信号,这表明PMR管理具有有利的风险益处概况.
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