固定复方卤倍他索丙酸酯和他扎罗汀乳膏治疗有色人种银屑病患者。

Fixed-Combination Halobetasol Propionate and Tazarotene Lotion for Psoriasis in Patients With Skin of Color.

出版信息

J Drugs Dermatol. 2021 Jul 1;20(7):744. doi: 10.36849/JDD.735.

PMID:34232005

Abstract

BACKGROUND

Few studies have examined topical psoriasis therapies in patients with skin of color. Fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) was investigated in two phase 3, multicenter, double-blind, vehicle-controlled trials (NCT02462070; NCT02462122). This post hoc analysis evaluated HP/TAZ in subgroups of non-White and White participants, including Hispanic/Latino participants, from these trials.

METHODS

Adult participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once daily for 8 weeks. Data were pooled and analyzed in non-mutually exclusive subgroups of self-identified non-White or White and Hispanic/Latino participants. Efficacy assessments included treatment success (≥2-grade improvement from baseline in investigator’s global assessment [IGA] and score of clear/almost clear), reduction from baseline in affected body surface area (BSA), and reduction in mean IGA × BSA. Safety was evaluated via treatment-emergent adverse events (TEAEs).

RESULTS

Of 418 participants, 60 and 358 self-identified as non-White and White, respectively; 115 of 418 participants self-identified as Hispanic/Latino. At week 8, a higher percentage of HP/TAZ-treated participants achieved treatment success vs vehicle (non-White, 34.4% vs 19.0%; White, 41.8% vs 8.7%; Hispanic/Latino, 39.3% vs 9.3%); rates for White and Hispanic/Latino participants were statistically significant. Compared with vehicle, HP/TAZ-treated participants in each subgroup experienced numerically greater reductions in affected BSA and IGA × BSA at week 8. The most common TEAEs were contact dermatitis, pruritus, nasopharyngitis, and application-site pain; discontinuations due to TEAEs were few.

CONCLUSIONS

HP/TAZ reduced disease severity in non-White, White, and Hispanic/Latino participants with psoriasis, with good tolerability and safety over 8 weeks of treatment. J Drugs Dermatol. 2021;20(7):735-744. doi:10.36849/JDD.6158.

摘要

背景

很少有研究检查过有色人种患者的局部银屑病治疗方法。固定剂量的卤倍他索丙酸（0.01%）和他扎罗汀（0.045%）乳剂（HP/TAZ）在两项 3 期、多中心、双盲、对照试验（NCT02462070；NCT02462122）中进行了研究。这项事后分析评估了来自这些试验的非白人和白人包括西班牙裔/拉丁裔参与者的 HP/TAZ 在非白人亚组和白人亚组中的疗效。

方法

成年参与者被随机（2:1）接受 HP/TAZ 或载体乳剂，每天一次，持续 8 周。对自我认定的非白人或白人及西班牙裔/拉丁裔参与者的非互斥亚组进行数据合并和分析。疗效评估包括治疗成功（从基线开始，研究者全球评估[IGA]和清晰/几乎清晰评分改善≥2 级）、从基线开始的受影响体表面积（BSA）减少，以及平均 IGA×BSA 的减少。通过治疗出现的不良事件（TEAEs）评估安全性。

结果

在 418 名参与者中，60 名和 358 名自我认定为非白人或白人，分别为 115 名自我认定为西班牙裔/拉丁裔。在第 8 周，接受 HP/TAZ 治疗的参与者达到治疗成功的比例高于接受载体治疗的参与者（非白人，34.4% vs 19.0%；白人，41.8% vs 8.7%；西班牙裔/拉丁裔，39.3% vs 9.3%）；白人参与者和西班牙裔/拉丁裔参与者的结果具有统计学意义。与载体相比，每个亚组接受 HP/TAZ 治疗的参与者在第 8 周时受影响的 BSA 和 IGA×BSA 均有更大程度的减少。最常见的 TEAEs 是接触性皮炎、瘙痒、鼻咽炎和应用部位疼痛；由于 TEAEs 而停药的情况很少。