J Allergy Clin Immunol:乌帕替尼+局部皮质激素可有效治疗特应性皮炎,效果至少持续52周

2022-04-10 MedSci原创 MedSci原创

正在进行的3期双盲AD Up研究(NCT03568318)的初步(第16周)结果显示,乌帕替尼+局部皮质激素(TCS)对中重度特应性皮炎患者明显积极的益处-风险概况。

正在进行的3期双盲AD Up研究(NCT03568318)的初步(第16周)结果显示,乌帕替尼+局部皮质激素(TCS)对中重度特应性皮炎患者明显积极的益处-风险概况。近日,发表于J Allergy Clin Immunol的最新研究评估了乌帕替尼 + TCS治疗52周的疗效和安全性。

研究纳入12至75岁的慢性中重度特应性皮炎患者(受影响体表面积≥10%,湿疹面积和严重程度指数[EASI]≥16,特应性皮炎有效调查者全球评估[vIGA-AD]≥3,以及最差瘙痒数字评分表[WP-NRS]得分≥4),1: 1:1随机接受每日一次的乌帕替尼 15毫克+TCS,或乌帕替尼 30毫克+TCS,或安慰剂(PBO)+TCS(在第16周重新随机接受乌帕替尼+TCS)。安全性和疗效的评估内容包括EASI(EASI-75)改善≥75%的患者比例,vIGA-AD清晰/几乎清晰且改善≥2级(vIGA-AD 0/1),以及WP-NRS改善≥4,评估至治疗第52周。

 

结果,在901名患者中,300名被随机分配到乌帕替尼 15毫克+TCS组,297名被分配到乌帕替尼 30毫克+TCS组,304名被分配到PBO+TCS名。就所有终点而言,乌帕替尼 15毫克+TCS和乌帕替尼 30毫克+TCS在第16周的疗效一直维持到第52周。在第52周,接受乌帕替尼15 mg + TCS和乌帕替尼 30 mg + TCS治疗的患者中,出现EASI-75的比例分别为50.8%和69.0%;出现vIGA-AD 0/1的比例分别为33.5%和45.2%;出现WP-NRS改善≥4的比例分别为45.3%和57.5%。乌帕替尼 + TCS在52周内的耐受性良好;没有观察到超出当前标签的新的重要安全风险事件。没有死亡病例报告;重大不良心血管事件和静脉血栓栓塞事件也并不常见(≤0.2/100患者-年)。

综上所述,这项为期52周的研究结果表明,乌帕替尼+TCS可有效治疗中重度AD患者,且疗效可长期保持,并具有良好的安全性。

原始出处:

Jonathan I Silverberg, et al., Upadacitinib plus topical corticosteroids in atopic dermatitis: Week 52 AD Up study results. J Allergy Clin Immunol. 2022 Mar;149(3):977-987.e14. doi: 10.1016/j.jaci.2021.07.036. 

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    2022-04-11 膀胱癌
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    2022-04-11 chg122
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    2022-04-10 ms7000001094178901

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    2022-04-10 ms8000001576078725

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