维护 瑞桑基祖马布在3期随机试验中维持了克罗恩病患者的诱导反应
Marc Ferrante1, Peter M Irving2, Maria T Abreu3
1Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
Journal of Crohn's & colitis
|October 5, 2023
概括
在克罗恩氏病患者中,risankizumab维持治疗持续的临床和内镜改善. 在中度至重度病例中,这种治疗在一年内表现出持久的疗效.
科学领域:
- 胃肠道学和免疫学
- 药理治疗炎症性肠病的药理治疗.
背景情况:
- 克罗恩病的治疗旨在实现持久的临床缓解,内镜治疗和生物标志物正常化.
- 瑞桑基祖马布是一种选择性抗联素-23p19抑制剂,在中度至重度克罗恩病中已显示出有效性.
- 以前的研究证实了在诱导疗法期间的瑞桑基祖马布的有效性.
研究的目的:
- 评估与瑞桑基祖马布维持治疗的临床和内镜结果的持久性.
- 评估瑞桑基祖马布的维持是否维持了诱导过程中获得的结果.
- 分析瑞桑基祖马布对克罗恩病生物标志物正常化的影响.
主要方法:
- 对FORTIFY维护研究 (NCT03105102) 的后期分析.
- 462名在诱导后获得临床反应的患者被重新随机分为每8周服用risankizumab (360 mg或180 mg SC) 或安慰剂,持续52周.
- 在第52周对临床,内镜和生物标志物终点维持的评估.
主要成果:
- 显著更高的克罗恩氏病活动指数缓解率 (68.6-70.8%对比56.3%) 和便/疼痛缓解率 (64.1-69.2%对比50.5%) 与risankizumab对比安慰剂.
- 在risankizumab组中,优越的内镜响应 (68.2-70.2%与38.4%) 和缓解 (45.5-74.4%与23.9%).
- 在56.8-83.3%的维持治疗患者中,便calprotectin或C-反应蛋白持续正常化.
结论:
- 皮下利桑基祖马布维持疗法在克罗恩病中提供了持久的临床和内镜改善.
- 该疗法维持了诱导期间获得的益处,提供了长期治疗选择.
- 瑞桑基祖马布在一年内对中度至重度活跃克罗恩病的管理中表现出持续的有效性.
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