在中度至重度活跃性结肠炎患者中的古塞尔库马布:QUASAR 2b期诱导研究
Laurent Peyrin-Biroulet1, Jessica R Allegretti2, David T Rubin3
1Department of Gastroenterology, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France; INSERM, NGERE, University of Lorraine, F-54000 Nancy, France; INFINY Institute, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France; FHU-CURE, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France; Groupe Hospitalier privé Ambroise Paré-Hartmann, Paris IBD Center, 92200 Neuilly sur Seine, France; Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada.
古塞尔库马布在诱导中度至重度性结肠炎 (UC) 患者的临床反应方面表现出显著的疗效. 在QUASAR第2b期研究中,Interleukin-23p19对抗剂被发现是安全有效的.
科学领域:
- 胃肠病学 胃肠病学
- 免疫学 免疫学 免疫学
- 临床药理学 临床药理学
背景情况:
- 性结肠炎 (UC) 是一种慢性炎症性肠病.
- 目前UC的治疗方法包括皮质类固醇,免疫抑制剂和先进疗法.
- 古塞尔库马布向的是介素-23p19亚单元,这是炎症途径的关键调解者.
研究的目的:
- 评估古塞尔库马布在中度至重度活跃UC的患者中的疗效和安全性.
- 为了确定静脉注射guselkumab的最佳诱导剂量.
- 与安慰剂相比,评估临床反应和缓解率.
主要方法:
- 一个双盲,安慰剂控制,剂量范围的2b期诱导研究 (QUASAR).
- 随机选择患者在0,4和8周接受静脉注射古塞尔库马布 (200或400毫克) 或安慰剂.
- 主要终点:12周临床反应,定义为修改后的梅奥得分下降.
主要成果:
- 与安慰剂 (27.6%;P <.001) 相比,古塞尔库马布 (200毫克和400毫克) 在第12周显示出显著更高的临床响应率 (61.4%和60.7%).
- 更多的古塞尔库马布治疗患者实现了二次终点,包括临床缓解和内镜改善.
- 在12周没有反应的患者中,随后的古塞尔库马布治疗导致24周的临床反应率为50-54.3%.
结论:
- 静脉输入的guselkumab诱导疗法在中度至重度活跃UC的患者中是有效的.
- 古塞尔库马布表现出有利的安全性,与安慰剂可比.
- 在两个guselkumab剂量组中,疗效和安全性是一致的.
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