在中度至重度的性结肠炎中,不同疾病活性指数的响应性
Virginia Solitano1, Remo Panaccione2, Bruce E Sands3
1Department of Medicine, Division of Gastroenterology, Western University, London, ON, Canada; Alimentiv, Inc., London, ON, Canada; Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, Università Vita-Salute San Raffaele, Milan, Italy.
Med (New York, N.Y.)
|October 5, 2024
概括
性结肠炎 (UC) 的疾病活性评分显示,对乌斯特基努马布治疗的反应类似. 修改后的梅奥诊所得分 (mMS) 建议作为主要终点,而UC-100得分适用于包括组织学评估在内的研究.
科学领域:
- 胃肠病学 胃肠病学
- 临床药理学 临床药理学
- 生物统计学 生物统计学
背景情况:
- 用各种临床,内镜,组织学和复合仪器评估性结肠炎 (UC) 疾病的活动.
- 目前的仪器包括梅奥诊所得分 (MCS),修改的MCS (mMS),部分MCS (pMS),罗巴特组织病理指数 (RHI) 和UC-100得分.
- 这些评分对治疗的响应性没有直接比较.
研究的目的:
- 为了比较不同性结肠炎 (UC) 疾病活性指数对乌斯特基努马布治疗的反应性.
- 评估各种复合分数和个别子分数在评估治疗反应中的有用性.
主要方法:
- 对UNIFI第3期诱导试验进行了后期分析.
- 患有中度至重度UC活性的参与者接受了乌斯特基努马布或安慰剂.
- 使用获胜概率 (WinP) 量化反应,将接受治疗与安慰剂参与者进行比较.
主要成果:
- UC-100评分 (WinP 0.72) 和修改后的梅奥诊所评分 (mMS;WinP 0.69) 显示对ustekinumab的反应很高.
- 在MCS的内镜子评分 (WinP 0.76) 和便频率子评分 (WinP 0.74) 中,反应很强.
- 炎症性肠病问卷 (IBDQ) 也显示出显著的响应 (WinP 0.78).
结论:
- 性结肠炎 (UC) 疾病活动指数表现出对ustekinumab的可比响应性.
- 评分的选择取决于治疗设置,评估时间点和测量可行性.
- 支持mMS作为复合初级终点,UC-100得分适用于结合组织学评估的研究.
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