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基于先前对先进疗法的不充分反应或不耐受性,基于risankizumab的疗效和安全性:INSPIRE和COMMAND第三阶段研究的后期分析

Remo Panaccione¹, Edouard Louis², Jean-Frederic Colombel³

¹Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada.

Journal of Crohn's & colitis

|January 13, 2025

概括

瑞桑基祖马布在性结肠炎患者中显示出有效性和安全性,即使是那些先前有先进治疗失败的患者. 这种插白素-23p19抑制剂提供了一个可行的治疗选择,不管之前的治疗史.

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:

治疗性结肠炎 (UC) 在以前接触过先进疗法 (AT) 的患者中可能具有挑战性.
瑞桑基祖马布 (risankizumab) 是一种介素-23p19 抑制剂,在对AT (AT-IR) 反应不足或不耐受的UC患者中进行评估.

研究的目的:

评估瑞桑基祖马布在UC患者的疗效和安全性,特别是分析基于先前先进治疗暴露的结果.
评估瑞桑基祖马布在对先进疗法 (AT-IR) 反应不足或不耐受患者的有效性.

主要方法:

第三阶段INSPIRE诱导研究:随机选择的患者在12周内静脉注射risankizumab 1200 mg或安慰剂.
第三期COMMAND维护研究:临床响应者随机分配给皮下里桑基祖马布180毫克,360毫克或安慰剂52周.
后期分析根据AT-IR状态,数量和作用机制评估了结果;AT包括生物药物,JAK抑制剂和S1P受体调节剂.

主要成果:

在诱导和维持期间,在非AT-IR和AT-IR组中,risankizumab与安慰剂相比,临床缓解率增加.
无论之前的AT的数量或作用机制如何,都观察到有效性,尽管非AT-IR患者的发病率更高.
在诱导和维护阶段,非AT-IR和AT-IR患者的安全概况在诱导和维护阶段是可比的.

结论:

瑞桑基祖马布是性结肠炎的有效和耐受性治疗方法.
无论先前的先进治疗暴露或失败,治疗的有效性和安全性都保持不变.

关键词:

冒着危险的生命危险.临床试验是指临床试验中的临床试验.性结肠炎是一种

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