Rapid Onset of Action in Patients With Moderate-to-Severe Plaque Psoriasis With Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination

August 2018 | Volume 17 | Issue 8 | Original Article | 863 | Copyright © 2018

Linda Stein Gold MD,a Leon H. Kircik MD,b David Pariser MD,c Jeffrey L. Sugarman MD PhD,d Tina Lin PharmD,e Robert Kang MS,f Radhakrishnan Pillai PhDg

aHenry Ford Hospital, Detroit, MI bIndiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY; Icahn School of Medicine at Mount Sinai, New York, NY cVirginia Clinical Research, Inc., Norfolk, VA dUniversity of California, San Francisco, CA eOrtho Dermatologics, Bridgewater, NJ fBausch Health, Bridgewater, NJ gDow Pharmaceutical Sciences Inc. (a division of Valeant Pharmaceuticals, North America, LLC.), Petaluma, CA

Abstract

Background: Psoriasis is a chronic condition often managed with topical therapy. Patients have high expectations about the speed at which improvement is achieved, which then can have a marked impact on the patient’s adherence to treatment. Recently, clinical data on a new fixed combination of halobetasol and tazarotene (HP/TAZ) have been presented. HP/TAZ lotion was statistically more effective than individual active ingredients or its vehicle, with a predictable safety profile. Objectives: Here we review the efficacy and tolerability data with a specific focus on the first two weeks of therapy. Methods: Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study in moderate or severe psoriasis (N=212). Subjects randomized (2:2:2:1 ratio) to receive halobetasol 0.01%/tazarotene 0.045% (HP/TAZ), individual active ingredients (HP or TAZ), or vehicle, once-daily for 8 weeks. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score and a score of ‘clear’ or ‘almost clear’), and impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion. Results: As early as 2 weeks, HP/TAZ lotion demonstrated statistically significant superiority for treatment success over vehicle (P equals 0.047) and TAZ (P equals 0.029). By week 2, 47.5% of patients were ‘mild’, ‘almost clear’ or ‘clear’ compared with 33.3%, 16.9%, and 12.9% of patients treated with HP, TAZ, or vehicle, respectively; plaque elevation and scaling were significantly improved compared with HP, TAZ, or vehicle, and erythema was significantly improved compared with TAZ. Improvements in baseline itching (45.6%), dryness (42.2%), burning/stinging (55.9%) with HP/TAZ lotion at 2 weeks were similar to those seen with HP, and greater than that achieved with TAZ (30.8% [P equals 0.099], 35.4%, and 13.3%, respectively). Conclusion: The HP/TAZ fixed combination lotion provides rapid relief of psoriasis symptoms, with apparent benefits over both HP and TAZ by week 2. J Drugs Dermatol. 2018;17(8):863-868.

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INTRODUCTION

Psoriasis is a chronic disease that has a substantial effect on quality of life (QoL), and the psychosocial disability suffered by psoriasis patients highlights the need for prompt, effective, and long-term disease control. Around 80% of patients have localized mild-to-moderate disease that can be treated with topical agents, including corticosteroids, vitamin D analogues, topical retinoids, and calcineurin inhibitors.Topical corticosteroids (TCS) have become the mainstay of treatment of various dermatoses including psoriasis,1 mainly due to their immunosuppressive, anti-inflammatory, and anti-proliferative properties.2,3 Although they are an integral part of the psoriasis therapeutic armamentarium, concerns about cutaneous adverse effects (AEs) prevent their long-term application. Strategies such as the weekend-only, a pulse therapy regimen, or combining TCS with other topical agents are important considerations for optimal use.3,4Recently, data on a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion were published.5 HP/TAZ lotion provided a synergistic effect compared to the

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