每天服用一次upadacitinib与成年人患有广泛非细分性白风的安慰剂相比:第二阶段,多中心,随机,双盲,安慰剂控制,剂量范围研究
Thierry Passeron1,2, Khaled Ezzedine3,4, Iltefat Hamzavi5
1INSERM U1065, Centre Méditerranéen de Médecine Moléculaire (C3M), Côte d'Azur University, Nice, France.
EClinicalMedicine
|June 14, 2024
概括
乌帕达西替尼有效治疗非细分性白风,导致成年人显著的皮肤再颜色化. 这种简氏激酶 (JAK) 抑制剂显示出作为广泛白风的新疗法选择的前景.
科学领域:
- 皮肤病学 皮肤病学
- 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:
- Vitiligo 是一种慢性自身免疫性疾病,其特征是皮肤脱色.
- 简氏激酶 (JAK) 抑制为白风提供了一个有前途的治疗策略.
- 乌帕达西尼布是一种口服选择性JAK抑制剂,研究用于非细分性白风治疗.
研究的目的:
- 评估阿帕达西提尼布在患有非细分性白风的成年人中的疗效和安全性.
- 为了确定upadacitinib在白风治疗中的最佳剂量.
- 评估upadacitinib在52周内对颜色的反颜色效应.
主要方法:
- 第二阶段,多中心,随机,双盲,安慰剂控制,剂量范围研究.
- 185名患有非细分性白风的成年患者被分配给上达西提尼布 (6,11或22毫克) 或安慰剂.
- 主要终点:面部白风区域评分指数 (F-VASI) 在24周的百分比变化;次要终点包括总白风区域评分指数 (T-VASI) 和安全性评估至52周.
主要成果:
- 与安慰剂相比,upadacitinib在24周对11毫克和22毫克剂量的F-VASI和T-VASI呈现了统计学上显著的改善.
- 在整个52周的治疗期间,观察到持续的皮肤再发色.
- 一般来说,不良反应与已知的安全性概况一致;在22毫克剂量时,观察到更高的断药率和严重的TEAE.
结论:
- 乌帕达西尼布单一治疗是面部和全身白风的有效治疗方法,可诱导显著的再颜色化.
- 乌帕达西提尼布为患有广泛非细分性白风的成年人提供了潜在的新疗法选择.
- 目前正在进行第三期试验,以进一步评估upadacitinib (15 mg) 在更广泛的患者群体中,包括青少年.
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