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

July 2021 | Volume 20 | Issue 7 | Journal Article | 744 | Copyright © July 2021


Published online June 28, 2021

doi:10.36849/JDD.6158

Andrew F. Alexis MD MPH,a Seemal R. Desai MD,b,c George Han MD PhD,d Abby Jacobson MS PA-Ce

aDepartment of Dermatology, Weill Cornell Medical College, New York, NY
bInnovative Dermatology, Plano, TX
cDepartment of Dermatology, The University of Texas Southwestern Medical Center, Dallas, TX
dIcahn School of Medicine at Mount Sinai, New York, NY
eOrtho Dermatologics (a division of Bausch Health US, LLC), Bridgewater, NJ

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

INTRODUCTION

Psoriasis is a common, chronic, inflammatory skin disease affecting ~2% of the population.1,2 Epidemiologic data suggest racial/ethnic variations in the prevalence of psoriasis, although assessment limitations exist, including under-detection and underreporting in non-White patient populations.3-7 Clinical characteristics and quality of life (QOL) effects of psoriasis may also differ across racial/ethnic groups.3,4,8-10 For example, Black patients with psoriasis have been reported to have more dyspigmentation, thicker plaques, more scaling, a larger proportion of affected body surface area (BSA), less erythema, and a greater negative impact on QOL compared with White patients.3,4,9 Postinflammatory hyperpigmentation or hypopigmentation as a sequela of psoriasis lesions is a particular cause for concern among many patients with skin of color.3,11

Despite differences in presentation and QOL effects, relatively few studies have investigated response to psoriasis treatment across racial/ethnic populations. Among systemic agents, post hoc subgroup analyses by race/ethnicity have been performed for clinical trials of brodalumab, etanercept, guselkumab, and secukinumab.9,12-15 Recently, a post hoc analysis of data from two clinical trials of treatment of plaque psoriasis found halobetasol propionate lotion (HP; 0.01%) to be significantly more effective than vehicle for Hispanic patients, consistent with results observed in the overall study population.16

Topical corticosteroids are the mainstay of psoriasis treatment, particularly for localized disease, and topical treatment is often used in conjunction with systemic or biologic therapy.17 Safety concerns associated with topical corticosteroids include local
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