Background

There is a significant need for novel, safe, and efficacious topical treatments for psoriasis.

Objective

We assessed the safety and efficacy of tapinarof in a new cream formulation at 2 concentrations and with 2 application frequencies in adults with psoriasis.

Methods

Double-blind, vehicle-controlled, randomized, 6-arm trial (1:1:1:1:1:1) in adults, with psoriasis with body surface involvement ≥1% and ≤15% and Physician Global Assessment (PGA) score ≥2 at baseline. Primary endpoint included PGA of 0 or 1 at week 12 and a 2-grade improvement from baseline. Additional analyses included assessment of ≥75% improvement of Psoriasis Area and Severity Index and mean percent change in Psoriasis Area and Severity Index and body surface area involvement.

Results

Treatment success defined by PGA 0 or 1 and a 2-grade improvement at week 12 was statistically significantly higher (at a .05 significance level) in the tapinarof groups (65% [1% twice daily], 56% [1% once daily], 46% [0.5% twice daily], and 36% [0.5% once daily]) than in the vehicle groups (11% [twice daily] and 5% [once daily]) and was maintained for 4 weeks posttreatment. Treatment-emergent adverse events were more frequent in patients treated with tapinarof (85/152, 56%) than vehicle (19/75, 25%) and mild-to-moderate in intensity. Severe treatment-emergent adverse events were reported in all tapinarof groups except the 0.5% once daily group.

Limitations

Large confirmation trials are needed.

Conclusions

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

中文翻译：

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Tapinarof（GSK2894512乳膏）用于治疗斑块状牛皮癣的第二阶段随机剂量研究

背景

迫切需要针对牛皮癣的新颖，安全和有效的局部治疗。

客观的

我们评估了成年牛皮癣成人中2种浓度和2种使用频率的新型乳膏制剂中塔比那洛的安全性和有效性。

方法

成人双盲，车辆对照，随机，6臂试验（1：1：1：1：1：1），银屑病患者的体表受累≥1％和≤15％，并通过医师全球评估（PGA）基线得分≥2。主要终点包括在第12周的PGA为0或1，并且较基线水平提高了2级。其他分析包括对牛皮癣面积和严重程度指数改善≥75％的评估以及牛皮癣面积和严重程度指数与身体表面积受累的平均百分比变化。

结果

在Tapinarof组中，由PGA 0或1定义的治疗成功和第12周的2级改善在统计学上显着更高（在.05显着性水平）（65％[1％每天两次]，56％[1％每天一次] ]，46％[0.5％每天两次]和36％[0.5％每天一次]相比于媒介物组（11％[每天两次]和5％[每天一次]）维持治疗4周。使用塔比那洛（85/152，56％）治疗的患者出现的治疗性不良事件比媒介物（19/75，25％）更为频繁，强度轻至中度。除每日一次0.5％的组以外，其他所有Tapinarof组均报告了严重的治疗紧急事件。

局限性

需要进行大型的确认试验。

结论

Tapinarof乳霜对成人牛皮癣患者有效且耐受性良好。