用于 3%-5%体表面积受累的银屑病患者的固定剂量复方卤倍他索/他扎罗汀乳膏。

Fixed-Combination Halobetasol Propionate/Tazarotene Lotion for Psoriasis in Patients With 3%-5% Affected Body Surface Area.

出版信息

J Drugs Dermatol. 2021 Aug 1;20(8):829-836. doi: 10.36849/JDD.6217.

Abstract

INTRODUCTION

Patients with psoriasis and low body surface area (BSA) involvement often experience substantially reduced quality of life and may be candidates for topical therapies. Fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) vs vehicle lotion was evaluated in participants with 3% to 5% BSA involvement.

METHODS

In two phase 3, multicenter, double-blind, vehicle-controlled, 8-week studies (ClinicalTrial.gov identifiers: NCT02462070/NCT02462122), adults with moderate/severe investigator’s global assessment (IGA) score were randomized 2:1 to once-daily HP/TAZ or vehicle. Pooled post hoc analyses included participants with baseline BSA involvement of 3% to 5%. Measures included treatment success (≥2-grade IGA reduction, clear/almost clear score), reduction in affected BSA, and clinically meaningful improvement (reduction) of ≥4 points on dermatology life quality index (DLQI).

RESULTS

Of 418 participants, 232 had baseline BSA involvement of 3% to 5% (HP/TAZ, n=149; vehicle, n=83). At week 8, 42.7% of HP/TAZ-treated participants achieved treatment success, compared with 11.4% of vehicle-treated participants (P< .001). Participants experienced significantly greater reductions in affected BSA at week 8 with HP/TAZ (-36.0%) vs vehicle (-1.6%; P< .001). Larger proportions experienced clinically meaningful DLQI improvements at week 8 with HP/TAZ (64.2%) vs vehicle (47.4%; P< .05). More participants achieved a ≥2-grade improvement in plaque elevation and scaling with HP/TAZ vs vehicle (each comparison, P< .001). Serious adverse events and discontinuations due to treatment-emergent adverse events were rare.

CONCLUSIONS

In participants with plaque psoriasis and BSA involvement of 3% to 5%, HP/TAZ provided significantly improved effectiveness after 8 treatment weeks vs vehicle lotion, with clinically meaningful improvements in quality of life. J Drugs Dermatol. 2021;20(8):829-836. doi:10.36849/JDD.6217.

摘要

介绍

患有银屑病且体表面积（BSA）受累小于 3%的患者通常生活质量明显下降，可能是局部治疗的候选者。评估了固定复方制剂卤倍他索丙酸（0.01%）和他扎罗汀（0.045%）乳液（HP/TAZ）与载体乳液在 3%至 5% BSA 受累的参与者中的应用。

方法

在两项 3 期、多中心、双盲、对照、8 周的研究中（ClinicalTrials.gov 标识符：NCT02462070/NCT02462122），中度/重度研究者整体评估（IGA）评分的成年参与者按 2:1 随机分为每日一次 HP/TAZ 或载体组。汇总的事后分析包括基线 BSA 受累为 3%至 5%的参与者。评估指标包括治疗成功（IGA 降低≥2 级，清除/几乎清除评分）、受累 BSA 减少和皮肤病生活质量指数（DLQI）改善≥4 分的临床意义改善。

结果

418 名参与者中，232 名基线 BSA 受累为 3%至 5%（HP/TAZ，n=149；载体，n=83）。第 8 周时，42.7%的 HP/TAZ 治疗组达到治疗成功，而接受载体治疗的参与者为 11.4%（P<.001）。与载体组（-1.6%；P<.001）相比，HP/TAZ 组在第 8 周时受累 BSA 减少更显著（-36.0%）。与载体组（47.4%；P<.05）相比，HP/TAZ 组第 8 周时 DLQI 改善更具临床意义的比例更大。与载体组相比，HP/TAZ 组在斑块隆起和脱屑方面有更多的患者达到≥2 级改善（每项比较，P<.001）。HP/TAZ 组与载体组相比，严重不良事件和因治疗引起的不良事件而停药的发生率均较低。