Treatment of atopic dermatitis with ruxolitinib cream (JAKI/JAK2 inhibitor) or triamcinolone cream
Treatment of atopic dermatitis with ruxolitinib cream (JAKI/JAK2 inhibitor) or triamcinolone cream
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DOI：
10.1016/j.jaci.2019.08.042
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发表时间：
2020-02-01
影响因子：
14.2
通讯作者：
Kuligowski, Michael E.
中科院分区：
文献类型：
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作者：
Kim, Brian S.;Howell, Michael D.;Kuligowski, Michael E.
背景：特应性皮炎(AD)是一种高度瘙痒的慢性炎症性皮肤病。目的：我们试图评价鲁索利替尼(ruxolitinib，Rux)乳膏治疗成人AD的有效性和安全性。方法：在这项2期研究(NCT03011892)中，307名成年AD患者，研究者的总体评估评分为2或3(轻或中度)，以及3%至20%的受累体表面积被随机分成8周，给予Rux(1.5%，每日两次，1.5%，每日一次，0.5%，qd，0.15%，每日一次)，赋形剂，或曲安奈德乳膏(0.1%，连续4周，然后赋形剂，4周)。随后，患者可以应用1.5%Rux Bid进行额外4周的开放标签治疗。主要终点是比较1.5%Rux霜Bid和赋形剂在4周时湿疹面积和严重程度指数与基线的平均百分比变化。结果：所有Rux方案在4周时均显示疗效，1.5%Bid对湿疹面积和严重程度指数改善最大(71.6%vs15.5%；P
Background: Atopic dermatitis (AD) is a highly pruritic chronic inflammatory skin disorder. Ruxolitinib, a selective inhibitor of Janus kinase 1 and Janus kinase 2, potently suppresses cytokine signaling involved in AD pathogenesis.Objective: We sought to evaluate the efficacy and safety of ruxolitinib (RUX) cream in adults with AD.Methods: In this phase 2 study (NCT03011892), 307 adult patients with AD, an Investigator's Global Assessment score of 2 or 3 (mild or moderate), and 3% to 20% affected body surface area were equally randomized for 8 weeks of double-blind treatment to RUX (1.5% twice daily [BID], 1.5% once daily [QD], 0.5% QD, 0.15% QD), vehicle, or triamcinolone cream (0.1% BID for 4 weeks, then vehicle for 4 weeks). Subsequently, patients could apply 1.5% RUX BID for 4 additional weeks of open-label treatment. The primary end point was the comparison between 1.5% RUX cream BID and vehicle in mean percentage change from baseline in Eczema Area and Severity Index at week 4.Results: All RUX regimens demonstrated therapeutic benefit at week 4; 1.5% BID provided the greatest improvement in Eczema Area and Severity Index (71.6% vs 15.5%; P