利桑基祖马布治疗性结肠炎:两项随机临床试验
Edouard Louis1, Stefan Schreiber2, Remo Panaccione3
1Department of Hepato-Gastroenterology and Digestive Oncology, University Hospital CHU of Liège, Liège, Belgium.
JAMA
|July 22, 2024
概括
与安慰剂相比,risankizumab在诱导和维持治疗试验中显著改善了性结肠炎患者的临床缓解率. 需要进一步的研究来评估超过52周的长期益处.
科学领域:
- 胃肠病学
- 免疫学
- 药理学
背景情况:
- 性结肠炎是一种慢性炎症性肠病,治疗选择有限.
- 作为一种选择性IL-23抑制剂,瑞桑基祖马布在治疗炎症方面具有潜力.
研究的目的:
- 评估瑞桑基祖马布作为中度至重度性结肠炎的诱导和维持治疗的疗效和安全性.
- 为了确定12周 (诱导) 和52周 (维持) 的临床缓解率.
主要方法:
- 两项3期随机临床试验 (诱导和维持) 涉及中度至严重UC患者.
- 患者接受了静脉注射的risankizumab或安慰剂诱导,随后是皮下注射的risankizumab或安慰剂维持.
- 主要结局是临床缓解,根据具体的便频率,直肠出血和内镜标准来定义.
主要成果:
- 在诱导试验中,接受瑞桑基祖马布治疗的患者中有20. 3% 在12周内实现了临床缓解,而接受安慰剂治疗的患者只有6. 2%.
- 在维持试验中,52周后临床缓解率为risankizumab的40. 2% (180 mg) 和37. 6% (360 mg),而安慰剂为25. 1%.
- 没有发现risankizumab治疗带来的新安全风险.
结论:
- 在中度至重度性结肠炎患者中,risankizumab在实现临床缓解方面表现出显著的有效性.
- 药物耐受性良好,在研究期间没有发现新的安全问题.
- 需要进一步的研究,以了解瑞桑基祖马布在52周以后的长期疗效和安全性.
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