罗氟司特乳膏 0.15%和 0.05%治疗特应性皮炎患者的安全性和疗效：随机、双盲、2 期概念验证研究。

The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05% in Patients With Atopic Dermatitis: Randomized, Double-Blind, Phase 2 Proof of Concept Study.

出版信息

J Drugs Dermatol. 2023 Feb 1;22(2):139-147. doi: 10.36849/JDD.7295.

DOI:10.36849/JDD.7295

PMID:36745371

Abstract

BACKGROUND

Patients with atopic dermatitis (AD) need safe and effective topical treatments.

OBJECTIVE

To assess safety and efficacy of roflumilast cream in patients with mild to moderate AD.

METHODS

In this phase 2, proof of concept trial, patients (N=136) aged ≥12 years with AD were randomized to once-daily roflumilast cream 0.15%, roflumilast cream 0.05%, or vehicle cream for 4 weeks. Absolute change from baseline in Eczema Area and Severity Index (EASI) score at week 4 (primary endpoint), percentage change and responder rates, Validated Investigator Global Assessment-AD (vIGA-AD), and safety were assessed.

RESULTS

At week 4, mean absolute changes in EASI were −6.4 (P=0.097 vs vehicle), −6.0 (P=0.356), and −4.8 with roflumilast 0.15%, roflumilast 0.05%, and vehicle, respectively. Significant improvements were observed for percentage change from baseline in EASI, patients reaching 75% improvement in EASI, and patients achieving vIGA-AD score of “clear” or “almost clear.” Treatment-related adverse events (AEs) occurred in 2 (2.2%) patients receiving roflumilast (mild rash and moderate application site pain). Only 1 (1.1%) patient receiving roflumilast discontinued study/drug due to an AE.

LIMITATIONS

Small number of patients.

CONCLUSIONS

Results support additional larger clinical trials of roflumilast cream to assess its potential as a once-daily, nonsteroidal topical AD treatment.

CLINICALTRIALS

gov identifier NCT03916081 J Drugs Dermatol. 2023;22(2):139-147. doi:10.36849/JDD.7295.

摘要

背景

特应性皮炎（AD）患者需要安全有效的局部治疗。

目的

评估罗氟司特乳膏治疗轻至中度 AD 患者的安全性和疗效。

方法

在这项 2 期、概念验证试验中，年龄≥12 岁的 AD 患者被随机分配至每日 1 次罗氟司特乳膏 0.15%、罗氟司特乳膏 0.05%或赋形剂乳膏，治疗 4 周。主要终点为第 4 周时 Eczema Area and Severity Index（EASI）评分相对于基线的绝对变化，以及百分比变化和应答率、验证性研究者整体评估-AD（vIGA-AD）和安全性。

结果

第 4 周时，EASI 的平均绝对变化分别为-6.4（P=0.097 与赋形剂相比）、-6.0（P=0.356）和-4.8，接受罗氟司特 0.15%、罗氟司特 0.05%和赋形剂治疗的患者分别如此。EASI 相对于基线的百分比变化、达到 EASI 改善 75%的患者比例和达到 vIGA-AD 评分“清除”或“几乎清除”的患者比例均显著改善。接受罗氟司特治疗的患者中有 2 例（2.2%）发生与治疗相关的不良事件（AE）（轻度皮疹和中度用药部位疼痛）。仅有 1 例（1.1%）接受罗氟司特治疗的患者因 AE 而停药/停药。