Halobetasol Propionate Lotion 0.01% for Moderate-to-Severe Plaque Psoriasis: Pooled Analysis in Male and Female Participants

August 2020 | Volume 19 | Issue 8 | Original Article | 747 | Copyright © August 2020


Published online July 30, 2020

Fran E. Cook-Bolden MDa, Adelaide A. Hebert MDb, Scott T. Guenthner MDc, Robert Kang MSd, Gina Martin MOTe, Abby Jacobson MS PA-Cf

aFran E. Cook-Bolden, MD, PLLC and Department of Dermatology, Mount Sinai Hospital Center, New York, NY bUTHealth McGovern Medical School, Houston, TX cThe Indiana Clinical Trials Center, PC, Plainfield, IN dBausch Health US, LLC*, Bridgewater, NJ eBausch Health US, LLC*, Petaluma, CA fOrtho 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.

Abstract
Introduction: Psoriasis is a chronic, immune-mediated skin disease that is associated with sex-related differences. Two double-blind, vehicle-controlled, phase 3 studies evaluated halobetasol propionate (HP) 0.01% lotion for the treatment of moderate-to-severe localized plaque psoriasis; pooled post hoc analyses investigated efficacy and safety in male and female subgroups.
Methods: Participants were randomized (2:1) to once-daily HP or vehicle lotion for 8-weeks of double-blind treatment, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in male (n=253) and female (n=177) subgroups included treatment success (≥2‑grade improvement in Investigator’s Global Assessment [IGA] score and score of ‘clear’ or ‘almost clear’), treatment success in psoriasis signs (erythema, plaque elevation, and scaling) at the target lesion, and change in affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated.
Results: At week 8, rates of IGA-rated treatment success were significantly greater for HP versus vehicle in males (34.0% vs 6.4%) and females (42.7% vs 14.6%; P<0.001 both). Treatment success in each psoriasis sign approached or exceeded 50% for HP-treated males and females, with all differences versus vehicle statistically significant (P<0.001). Percent reduction in affected BSA was significantly greater for HP versus vehicle in males (34.9% vs 6.7%) and females (35.6% vs 4.6%; P<0.001 both). Five HP treatment-related TEAEs (all application site-related) were reported through week 8.
Conclusions: HP lotion was associated with significant reductions in disease severity in male and female participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks of once-daily use. In the overall pooled population, results were similar.

J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5250

INTRODUCTION

Plaque psoriasis is a chronic, immune-mediated skin disease characterized by well-defined raised, erythematous oval plaques; lesions are often located on the scalp, trunk, buttocks, and limbs.1 Plaque psoriasis affects 80%-90% of individuals with psoriasis; 80% of cases have mild-to-moderate severity and can be managed with topical therapies alone.1,2 Topical corticosteroids, whose actions are anti-inflammatory, antiproliferative, immunosuppressive, and vasoconstrictive, are the foundation of treatment for the majority of people with psoriasis, particularly those with limited disease.3 Although the chronic nature of psoriasis often requires long-term treatment, use of highly potent topical corticosteroids is generally limited to 2 to 4 weeks to avoid increased risk of cutaneous side effects and systemic absorption.3 In the United States, the prevalence of psoriasis does not differ between men and women,4 although studies have indicated that sex-related differences may exist. For example, men have been shown to have greater disease severity than women5 and they are more likely to seek out specialized dermatology care.6 In terms of treatment, men are more likely than women to receive systemic treatment for psoriasis, whereas women are more likely to be treated with topical agents.5 Additionally, although diminished quality of life resulting from stigma, stress, anxiety, depression, and impaired work productivity is experienced by many individuals with psoriasis,7-9 psoriasis-related burden of illness is reported to be greater for women than men.10