Halobetasol Propionate 0.01%/Tazarotene 0.045% Lotion for Moderate-to-Severe Psoriasis: Pooled Phase 3 Analysis of Lower Extremities

April 2020 | Volume 19 | Issue 4 | Original Article | 389 | Copyright © April 2020


Published online March 20, 2020

doi:10.36849/JDD.2020.4958

Stephen Tyring MD PhD,a Leon H. Kircik MD,b Paul Yamauchi MD PhD,c Abby Jacobson MS PA-C,d Tina Lin PharmDd

aUniversity of Texas Health Science Center, Houston, TX bIndiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY; and Icahn School of Medicine at Mount Sinai, New York, NY cDermatology Institute & Skin Care Center, Inc., Santa Monica, CA dOrtho Dermatologics,* Bridgewater, NJ *Ortho Dermatologics is a division of Bausch Health US, LLC.

Abstract
Background: Plaque psoriasis can occur in all body regions, with the trunk and extremities among the most commonly affected areas. A fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion demonstrated efficacy and safety in patients with moderate-to-severe localized plaque psoriasis. This analysis evaluated patients where a psoriatic target lesion was identified on the leg. Methods: In two phase 3, multicenter, double-blind studies, participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once-daily for 8 weeks. This pooled, post hoc analysis included a subset of participants who had a leg target lesion (HP/TAZ, n=148; vehicle, n=71). Efficacy assessments included treatment success (≥2-grade improvement) in psoriasis signs (erythema, plaque elevation, scaling) on the leg target lesion, and overall treatment outcomes, including overall treatment success (≥2-grade improvement in Investigator’s Global Assessment [IGA] score and score of clear/almost clear), affected Body Surface Area (BSA), and IGAxBSA composite score.
Results: Psoriasis signs were reduced by week 8, with more HP/TAZ treated participants achieving treatment success for erythema (41.6%), plaque elevation (58.5%), and scaling (59.5%) on the leg compared with vehicle (12.5%, 19.2%, and 21.0%, respectively; P<0.001 all). Significantly more participants achieved overall treatment success at week 8 with HP/TAZ versus vehicle (36.4% vs 10.4%; P<0.001). The HP/TAZ group also had a greater mean reduction in affected BSA and IGAxBSA score versus vehicle (P<0.001, both). The most frequently reported treatment-related adverse event (incidence, ≥3%) with HP/TAZ was contact dermatitis.
Conclusions: HP 0.01%/TAZ 0.045% lotion was associated with significant reductions in disease severity and good tolerability following 8 weeks of treatment in patients where a psoriatic target lesion was identified on the leg.

J Drugs Dermatol. 2020;19(4): doi:10.36849/JDD.2020.4958

INTRODUCTION

Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression.1 Although there are different types of psoriasis, plaque psoriasis is by far the most common type and makes up approximately 90% of cases.2 Plaque psoriasis can occur across all regions of the body, though the trunk and extremities are among the most commonly affected areas.3

The impact of psoriasis on overall disease burden and patient quality of life may vary depending on the location of psoriatic lesions.4 In addition, the treatment of certain body regions can be more problematic than others,5,6 with certain areas being more resistant to treatment or requiring longer treatment periods to achieve clearance of symptoms.5-8 However, more data is needed to better understand the relationship between psoriasis location and treatment response. The use of topical therapy is a key component in the management of almost all psoriasis patients.9 However, long-term safety of corticosteroids remains a concern, as use is limited to 2-3 consecutive weeks for most topical steroids. Recent phase 3 clinical data have demonstrated that a once-daily, fixed-combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion was significantly more effective than vehicle
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