Background

Safe and efficacious topical treatments are needed for atopic dermatitis (AD).

Objective

We assessed the safety and efficacy of tapinarof cream (2 concentrations and 2 application frequencies) in patients with AD.

Methods

A double-blind, vehicle-controlled, randomized, 6-arm trial (1:1:1:1:1:1) in patients age 12 to 65 years, with body surface area involvement of at least 5% to 35% and an Investigator's Global Assessment score of 3 or higher (moderate to severe) at baseline. Primary end points included an Investigator's Global Assessment score of clear or almost clear (0 or 1) and a minimum 2-grade improvement (treatment success) at week 12. Secondary analyses included a 75% or greater improvement in Eczema Area and Severity Index score, reduction of numeric rating scale (NRS) score for itch from baseline, and other prespecified end points.

Results

The rates of treatment success with tapinarof cream at week 12 were 53% (a concentration of 1% twice daily), 46% (a concentration of 1% once daily), 37% (a concentration of 0.5% twice daily), 34% (0.5% once daily), 24% (vehicle twice daily), and 28% (vehicle once daily). The rate with a concentration of 1% twice daily (53%) was statistically significantly higher than the rate with vehicle twice daily (24%). Treatment success was maintained for 4 weeks after the end of tapinarof treatment. The rate of treatment-emergent adverse events was higher with tapinarof (93 of 165 [56%]) than with vehicle (34 of 82 [41%]), and the events were mild to moderate in intensity.

Limitations

Large confirmation trials are needed.

Conclusions

Tapinarof cream is efficacious and well tolerated in adolescent and adult patients with AD.

中文翻译：

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Tapinarof（GSK2894512乳膏）用于治疗特应性皮炎的第2期随机剂量研究

背景

特应性皮炎（AD）需要安全有效的局部治疗。

客观的

我们评估了塔比那洛乳膏（2种浓度和2种应用频率）在AD患者中的安全性和有效性。

方法

在12至65岁的患者中进行的一项双盲，随机对照，六臂试验（1：1：1：1：1：1），其体表面积至少为5％至35％，并且基线时调查员的整体评估得分为3或更高（中度到重度）。主要终点包括研究人员在12周时的总体评估得分清晰或几乎清晰（0或1），以及至少2级改善（治疗成功）。次要分析包括湿疹面积和严重性指数得分提高了75％或更高。 ，从基线开始的瘙痒数字评分等级（NRS）得分降低，以及其他预先指定的终点。

结果

在第12周时使用Tapinarof乳霜的治疗成功率分别为53％（每天两次，浓度为1％），46％（每天一次，浓度为1％），37％（每天两次，浓度为0.5％），34％ （每天一次0.5％），24％（每天两次）和28％（每天一次）。每天两次浓度为1％的比率（53％）在统计学上显着高于每天两次媒介物的浓度（24％）。in虫治疗结束后，治疗成功维持了4周。Tapinarof的紧急治疗不良事件发生率（165例中的93例[56％]）高于媒介物（82例中的34例[41％]），事件的轻度至中度。

局限性

需要进行大型的确认试验。

结论

Tapinarof乳霜对青少年和成人AD患者有效且耐受性良好。