Safety and Efficacy of a Fixed Combination Halobetasol and Tazarotene Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: A Pooled Analysis of Two Phase 3 Studies

August 2018 | Volume 17 | Issue 8 | Original Article | 855 | Copyright © 2018

Jeffrey L. Sugarman MD PhD,a Jonathan Weiss MD,b Emil A. Tanghetti MD,c Jerry Bagel MD,d Paul S. Yamauchi MD,e Linda Stein Gold MD,f Tina Lin, PharmD,g Gina Martin MOT,h Radhakrishnan Pillai PhD,h Robert Israel MDi

aUniversity of California, San Francisco, CA bGwinnett Dermatology, PC, and Gwinnett Clinical Research Center, Inc, Snellville, GA cCenter for Dermatology and Laser Surgery, Sacramento, CA dPsoriasis Treatment Center of Central New Jersey, East Windsor, NJ eDavid Geffen School of Medicine at UCLA, Los Angeles, CA fHenry Ford Hospital, Detroit, MI gOrtho Dermatologics, Bridgewater, NJ hDow Pharmaceutical Sciences Inc. (a division of Valeant Pharmaceuticals, North America, LLC.), Petaluma, CA iBausch Health, Bridgewater, NJ

Abstract

Background: Topical corticosteroids (TCS) are the mainstay of psoriasis treatment. Safety concerns may limit use. Combination with tazarotene may optimize efficacy and minimize safety and tolerability concerns. Objective: Investigate safety and efficacy of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis. Methods: Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=418). Subjects randomized (2:1) to HP/TAZ lotion or vehicle once-daily for 8 weeks, 4-week follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in IGA score and ‘clear’ or ‘almost clear’). Safety and treatment emergent AEs evaluated throughout. Results: HP/TAZ lotion demonstrated statistically significant superiority over vehicle as early as week 2 (P equals 0.002). By week 8, 40.6% of subjects were treatment successes compared with 9.9% on vehicle (P less than 0.001). A third of subjects remained treatment successes post-treatment. HP/TAZ lotion was also superior in reducing psoriasis signs and symptoms, and Body Surface Area (BSA) involvement. Most frequently reported treatment related AEs were contact dermatitis (6.3%), application site pain (2.6%), and pruritus (2.2%). Limitations: No data were collected beyond the 4-week follow-up. Conclusions: HP/TAZ lotion provides synergistic efficacy that is both rapid and sustained, with good tolerability and safety over 8 weeks use. J Drugs Dermatol. 2018;17(8):855-861.

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INTRODUCTION

Psoriasis is a chronic, immune-mediated disease affecting almost 2% of the population.1-3 Topical therapy is a key component in the management of almost all psoriasis patients, considered first-line therapy for mild disease, and often used alone or in conjunction with systemic agents in more severe psoriasis.4While the use of topical corticosteroids (TCS) are routine in psoriasis due to their efficacy, long-term safety concerns still limit their use to 2-4 weeks continuous use. Tazarotene too has also been shown to be an effective psoriasis treatment.5,6 However, its use is limited by skin irritation. The use of fixed combination topical treatments in dermatology is commonplace. Combining a TCS with tazarotene may prevent the irritancy effects of tazarotene, decrease the risk of steroid-induced atrophy,7,16 and provide greater efficacy.14,15Recently, phase 2 clinical data on 8 weeks’ treatment of moderate-to-severe psoriasis with a novel fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion formulation were published.8 The fixed combination was synergistic, providing clinical benefits beyond those expected from the efficacy of the individual active ingredients. In addition, it was well-tolerated following 8 weeks daily application, and efficacy was maintained 4 weeks post-treatment.

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