Once-Daily Halobetasol Propionate 0.01% Lotion for Moderate-to-Severe Plaque Psoriasis: Phase 3 Analysis of Hispanic Participants
March 2021 | Volume 20 | Issue 3 | Original Article | 252 | Copyright © March 2021
Published online February 12, 2021
Seemal R. Desai MD,a Brad Glick DO MPH,B James Q. Del Rosso DO,c Susan Harris MS,d Abby Jacobson MS PA-Ce
aInnovative Dermatology, PA, Plano, TX; The University of Texas Southwestern Medical Center, Dallas, TX
bGSI Clinical Research, Margate, FL
cJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV
dBausch Health US, LLC*, Bridgewater, NJ
eOrtho Dermatologics*, Bridgewater, NJ
*Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.
Background: Psoriasis is a chronic, inflammatory disease that may differ in prevalence and clinical presentation among patients from various racial and ethnic groups. Two phase 3 studies demonstrated efficacy and safety of halobetasol propionate (HP) 0.01% lotion in the treatment of moderate-to-severe plaque psoriasis (NCT02514577, NCT02515097). These post hoc analyses evaluated HP 0.01% lotion in Hispanic participants.
Methods: Participants were randomized (2:1) to receive once-daily HP or vehicle lotion for 8 weeks, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in Hispanic participants (HP, n=76; vehicle, n=43) included treatment success (≥2‑grade improvement in Investigator's Global Assessment and score of 'clear' or 'almost clear'), psoriasis signs, and affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated.
Results: At week 8, 38.8% of participants achieved treatment success with HP versus 10.3% on vehicle (P=0.001). HP‑treated participants achieved greater improvements in psoriasis signs, compared with vehicle (P<0.01 all). HP group had a greater reduction in affected BSA versus vehicle (P=0.001). Treatment-related TEAEs with HP were application site infection and dermatitis (n=1 each). Conclusions: Once-daily HP 0.01% lotion was associated with significant reductions in disease severity in Hispanic participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks.
J Drugs Dermatol. 20(3):252-258. doi:10.36849/JDD.2021.5698
Psoriasis is a chronic, inflammatory immune-mediated disease that occurs throughout the world.1 Although dermatologic disorders are common in all racial and ethnic groups,2 clinical data on psoriasis in skin of color is limited. From the data that are available, it appears that differences pertaining to prevalence, affected body surface area (BSA), clinical presentation, and quality of life exist among patients with psoriasis from various racial and ethnic groups.3-6 For example, the estimated prevalence of psoriasis among adults in the United States (US) is higher in the White population (3.6%) than in Black/African American (1.9%) and Hispanic (1.6%) populations.3 However, because psoriasis is more frequently undiagnosed in people of color, the prevalence of psoriasis in non-White populations is likely to be underestimated.7,8
Although the Hispanic population is the largest and fastest growing ethnic group in the US,9,10 there is little available evidence regarding the efficacy and safety of psoriasis therapies in this population.4,11,12 In Hispanic patients of any race, psoriasis is the third leading diagnosis in dermatology clinics, even though Hispanic patients may be less likely to seek dermatologic care compared with other races or ethnicities.2 Further, data have shown greater disease severity, worse psoriasis-related quality of life, and higher levels of undertreatment for psoriasis among Hispanic patients compared with other racial and ethnic groups.2,4,13,14 Given the rapid growth of the Hispanic population, the characteristic nature of psoriasis in Hispanic patients, and undertreatment in this ethnic subgroup, additional studies of psoriasis are warranted so ethno-racial differences in psoriasis may be better understood and treatment disparities among Hispanic patients can be addressed.
Topical corticosteroids are the mainstay of psoriasis treatment, providing a high efficacy-to-safety ratio during daily use.15
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