Halobetasol 0.01%/Tazarotene 0.045% Lotion for Moderate-to-Severe Psoriasis: Pooled Phase 3 Analysis of Males and Females

May 2020 | Volume 19 | Issue 5 | Original Article | 504 | Copyright © May 2020

Published online April 24, 2020

Linda Stein Gold , Boni Elewski , Zoe Draelos , Abby Jacobson , Tina Lin

aHenry Ford Hospital, Detroit, MI bUniversity of Alabama at Birmingham School of Medicine, Birmingham, AL cDermatology Consulting Services, PLLC, High Point, NC dOrtho Dermatologics*, Bridgewater, NJ *Ortho Dermatologics is a division of Bausch Health US, LLC.

Abstract
Background: Previous results from two phase 3 studies demonstrated efficacy and safety of fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in participants with moderate-to-severe plaque psoriasis. This post hoc analysis evaluated sex-specific efficacy and safety of HP/TAZ lotion.
Methods: In two randomized, double-blind, phase 3 studies, participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once daily for 8 weeks. Male and female participants were evaluated separately in this pooled analysis. Efficacy assessments included treatment success (at least 2‑grade improvement in Investigator's Global Assessment [IGA] score and score of clear/almost clear), impact on individual signs of psoriasis, and affected Body Surface Area (BSA).
Results: The analysis included 272 males (HP/TAZ, n=175; vehicle, n=97) and 146 females (HP/TAZ, n=101; vehicle, n=45). Significantly more participants achieved overall treatment success at week 8 with HP/TAZ versus vehicle in both male (38.4% vs 9.8%) and female (44.5% vs 9.9%) subgroups (P<0.001, both). Erythema, plaque elevation, and scaling were also reduced by week 8 in both males and females, with significantly more HP/TAZ-treated participants achieving at least 2‑grade improvement in each sign of psoriasis than vehicle-treated participants (P<0.001 each, both groups). Mean reductions in affected BSA were significantly greater with HP/TAZ versus vehicle lotion in both males and females (P≤0.001, both). The most frequent treatment-related adverse events were contact dermatitis, pruritis, and application site pain (each 4.0%) in females and contact dermatitis (7.6%) in males.
Conclusion: HP/TAZ lotion was highly effective and safe in both males and females with moderate-to-severe psoriasis over 8 weeks of once-daily use.

J Drugs Dermatol. 2020;19(5): doi:10.36849/JDD.2020.5021

INTRODUCTION

Psoriasis is an inflammatory skin condition common in the Western world, affecting 2-4% of the population.1,2 Although prevalence is similar in males and females,1 some sex-specific differences have been identified, including age of onset,3 disease severity,4 types of treatment,5 adherence rates,6 and global satisfaction.7,8 For instance, males are more likely to have greater disease severity and to receive more intensive systemic therapies, particularly biologics,5 while females have higher rates of adherence6 yet are more dissatisfied with treatment because of side effects and quality-of-life issues.7-10 For these reasons, new therapies for moderate-to-severe psoriasis, particularly medications that are safe and effective in females, are needed to address sex-specific concerns.

Topical therapy using corticosteroids is a mainstay for management of most psoriasis patients. For mild disease, it is a first-line strategy, while corticosteroids are often used as adjunctive agents along with systemic treatments for more severe psoriasis.11 However, topical corticosteroid use is limited by safety concerns associated with long-term administration beyond 2-4 weeks, which may be mitigated by combining these drugs with another common psoriasis medication, tazarotene.12 Such a pairing has the potential to reduce risk of steroid-induced atrophy and tazarotene-induced irritancy while enhancing efficacy and maintaining therapeutic benefit.13,14 The fixed combination of halobetasol propionate 0.01%/tazarotene 0.045% lotion (HP/TAZ), which uses novel polymeric emulsion technology to create a synergistic effect, has demonstrated better active ingredient absorption than separately layering HP and TAZ.15,16 In addition, HP/TAZ lotion has been shown in previous phase 3 studies to offer rapid and sustained effectiveness and good tolerability.17,18 In this paper, we present results from a post hoc analysis evaluating sex-specific efficacy and safety of HP/TAZ lotion for the treatment of moderate-to-severe psoriasis.