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埃特拉西莫德在性结肠炎中的有效性:根据基线内镜严重程度对ELEVATE UC 52和ELEVATE UC 12的分析
Andres J Yarur1, Walter Reinisch2, Shannon Chang3
1Inflammatory Bowel Disease Center and Division of Gastroenterology and Hepatology, Cedars-Sinai Medical Center, Los Angeles, California.
埃特拉西莫德有效治疗中度至严重的性结肠炎,在12周和52周内显着缓解内学疾病的临床症状. 在严重的病例中,疗效可能会在经过12周的治疗后得到改善.
科学领域:
- 胃肠病学 胃肠病学
- 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:
- 埃特拉西莫德是一种口服的,选择性的基-1-酸盐 (S1P) 1,4,5受体调节剂.
- 它适用于中度至重度活跃的性结肠炎.
研究的目的:
- 评估2毫克埃特拉西莫德与安慰剂的诱导和维持疗效.
- 在性结肠炎患者中,根据基线内镜严重程度 (中度与严重) 评估疗效.
主要方法:
- 对ELEVATE UC 52和ELEVATE UC 12试验进行了后期分析.
- 根据基线内镜子评分 (中度为2,重度为3) 和修改后的梅奥得分分层分的患者.
- 在第12周和第52周评估的疗效终点.
主要成果:
- 与安慰剂相比,在第12周和第52周的中度和重度内镜疾病亚组中,埃特拉西莫德显著增加了临床缓解率 (P < .001).
- 患有严重内镜疾病的患者在第52周与第12周相比,在数值上表现出更高的终点成就.
- 根据先前的生物/Janus 激酶抑制剂暴露的子组分析也得出了类似的发现.
结论:
- 埃特拉西莫德在中度和重度内镜疾病的性结肠炎患者中,比安慰剂具有显著的诱导和维持疗效.
- 在患有严重内镜疾病的患者中,疗效可能会在最初的12周诱导期之后继续改善.
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