在中度至重度性结肠炎的患者中使用奥萨尼莫德,对先进疗法天真
Bruce E Sands1, Geert D'Haens2, Remo Panaccione3
1Icahn School of Medicine at Mount Sinai, New York, New York.
奥扎尼莫德为未经先进疗法治疗的性结肠炎患者提供一种有效且耐受良好的口服治疗方法. 在真北试验中的这项研究表明,通过维护和延长期间,有效性和安全性是持久的.
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:
- 性结肠炎 (UC) 是一种慢性炎症性肠病.
- 先进疗法 (AT) 用于中度至重度的UC.
- 奥萨尼莫德是一种口服的基1-酸盐受体调节剂.
研究的目的:
- 为了评估ozanimod在AT-naive患者中对中度至重度活跃UC的疗效和安全性.
- 在真北 (TN) 研究及其开放式扩展 (OLE) 期间评估ozanimod的长期影响.
主要方法:
- 该TN研究是一项随机,双盲,安慰剂对照试验,具有诱导和维持期.
- 患者接受了ozanimod或安慰剂,符合条件的患者进入了OLE.
- 疗效结局包括症状,临床,内镜和粘膜愈合评估.
主要成果:
- 与安慰剂相比,Ozanimod在第4周显示出显著更大的症状反应 (56%对39%).
- 连续接受ozanimod治疗的患者维持了临床反应 (91%),并通过OLE 94.4周显示内镜改善 (74%) 和粘膜愈合 (57%).
- 安全概况与整个TN人口一致.
结论:
- 奥扎尼莫德在没有AT的UC患者中显示出持久的疗效和良好的耐受性安全性.
- 对于这种患者群体,ozanimod提供了一种有效的口服治疗选择.
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