里奥西瓜特在早期扩散性皮肤全身性硬化症 (RISE-SSc) 患者中:开放标签,长期延长2b期,随机化,安慰剂对照试验
Oliver Distler1, Yannick Allanore2, Christopher P Denton3
1Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
The Lancet. Rheumatology
|January 22, 2024
概括
在早期的扩散性皮肤系统性硬化症中,长期使用里奥西瓜特治疗没有显示出新的安全问题. 这项扩展研究评估了额外一年的安全性和治疗效果.
科学领域:
- 类风湿病学 类风湿病学
- 心脏病学 心脏病学
- 肺部病理学 肺部病理学
背景情况:
- 在分散性皮肤系统性硬化症 (RISE-SSc) 患者的里奥西瓜特安全性和有效性试验中,对早期分散性皮肤系统性硬化症的里奥西瓜特进行了评估.
- 一个长期延期评估了 riociguat 的安全性和探索性治疗效果.
研究的目的:
- 评估里奥西瓜特在患有早期扩散性皮肤全身性硬化症的患者的长期安全性.
- 为了探索 riociguat 在长时间内潜在的治疗效果.
主要方法:
- 完成52周RISE-SSc试验的患者有资格获得长期延长.
- 参与者接受了riociguat,在10周内调整剂量,然后进行开放阶段.
- 安全评估包括不良事件和严重不良事件.
主要成果:
- 87名患者进入了扩展 (42名riociguat-riociguat,45名安慰剂-riociguat).
- 94%的患者经历了不良事件,大多为轻度至中度.
- 在患有间歇性肺病的患者中,没有观察到与肺相关的严重不良事件的增加.
结论:
- 长期服用里奥西瓜特在该患者群体中没有显示出新的安全信号.
- 扩展的开放性质和缺乏对比组是研究的局限性.
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