作为中度至重度活跃性性结肠炎的诱导和维持疗法,upadacitinib:来自三个第三期多中心双盲随机试验的结果
Silvio Danese1, Séverine Vermeire2, Wen Zhou3
1Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy.
Lancet (London, England)
|June 1, 2022
概括
在性结肠炎患者中,Upadacitinib 是一种 Janus 激酶 1 抑制剂,有效诱导并维持了缓解. 它显示出良好的安全性,为中度至严重的疾病提供了新的治疗选择.
科学领域:
- 胃肠病学和肝病学
- 免疫学和风湿学
- 药理学和制药科学
背景情况:
- 在性结肠炎 (UC) 中提供快速,强大和持续的疾病控制的先进疗法存在显著的未满足需求.
- 在UC中对口服选择性Janus激酶1 (JAK1) 抑制剂Upadacitinib进行了诱导和维持治疗的评估.
研究的目的:
- 在中度至重度活跃的性结肠炎患者中评估upadacitinib的疗效和安全性.
- 确定upadacitinib作为UC患者的诱导和维持治疗的潜力.
主要方法:
- 3期多中心,随机,双盲,安慰剂控制的临床计划,包括两项诱导 (UC1,UC2) 和一项维持 (UC3) 研究.
- 患有中度至重度UC的患者 (年龄在16- 75岁) 接受了45毫克的口服上达西替尼或安慰剂8周的诱导治疗.
- 受试者参加了为期52周的维持研究,随机分别接受上达西提尼布 (15 mg或30 mg) 或安慰剂.
主要成果:
- 在诱导研究中,相对于安慰剂,upadacitinib 45 mg显著增加了临床缓解率 (UC1: 26% 对比5%;UC2: 34% 对比4%;P< 0. 0001).
- 在维持研究中,相对于安慰剂,upadacitinib (15 mg和30 mg) 显著改善了临床缓解率 (42%和52%对12%;P< 0. 0001).
- 与安慰剂相比,阿帕达西尼布的不良反应通常较少;严重的不良事件和停药也较少.
结论:
- 在中度至重度活性的性结肠炎患者中,upadacitinib在诱导和维持临床缓解方面表现出显著的有效性.
- 与安慰剂相比,该药物具有积极的安全性,严重不良事件和治疗中止率较低.
- 在中度至重度性结肠炎患者中,upadacitinib 是一个有前途的新口服治疗方案.
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