Assessing the Synergistic Effect of a Fixed Combination Halobetasol Propionate 0.01% and Tazarotene 0.045% Lotion in Moderate-to-Severe Plaque Psoriasis

March 2019 | Volume 18 | Issue 3 | Original Article | 279 | Copyright © 2019

Leon H. Kircik MD,a Kim A. Papp MD PhD,b Linda Stein Gold MD,c Susan Harris MS,d Tina Lin Pharm D,e Radhakrishnan Pillai PhDf

aIndiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY; Icahn School of Medicine at Mount Sinai, New York, NY bK Papp Clinical Research and Probity Medical Research, Waterloo, ONT, Canada cHenry Ford Hospital, Detroit, MI dBausch Health, Bridgewater, NJ EOrtho Dermatologics, Bridgewater, NJ fBausch Health Americas, Inc., Petaluma, CA

Abstract

BACKGROUND: Fixed combinations are commonplace in dermatology, providing significant efficacy and tolerability benefits. In some cases, two active ingredients complement each other providing a cumulative or additive effect. In rarer cases, a synergistic effect may be seen where the sum of the two active ingredients combined action is greater than the sum of the efficacy of the constituent parts.

OBJECTIVE: To determine whether a novel halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) fixed combination lotion provides a synergistic effect in the treatment of moderate-to-severe plaque psoriasis.

METHODS: Post hoc analysis of 212 patients with moderate-to-severe plaque psoriasis randomized (2:2:2:1) to HP/TAZ lotion, HP, TAZ or vehicle once-daily for 8 weeks, with a 4-week posttreatment follow-up. Treatment success was evaluated based on two outcomes: percent of patients achieving at least a 2-grade improvement in Investigator Global Assessment (IGA) and IGA score equating to ‘clear’ or ‘almost clear’; and percent change from baseline in the IGAxbody surface area (BSA) score, an alternative to assessing response to therapy that is more sensitive to area change than the Psoriasis Area Severity Index (PASI). In addition, a clinically meaningful outcome was reported in patients who achieved a 75% reduction in IGAxBSA. Synergy was established when the benefit of combination HP/TAZ lotion was greater than benefit of HP plus TAZ, with a ratio (HP/TAZ divided by HP+TAZ) >1.0.

RESULTS: HP/TAZ lotion was synergistic at week 8, and four weeks posttreatment. At week 8, treatment success with HP/TAZ lotion relative to vehicle was 42.8% compared with 32.5% for HP plus TAZ (ratio 1.3); and percent change from baseline in IGAxBSA score relative to vehicle was 51.6% compared with 40.6% for HP plus TAZ (ratio 1.3). At week 12, treatment success with HP/TAZ lotion relative to vehicle was 31.3% compared with 20.0% for HP plus TAZ (ratio 1.6). Percent change from baseline in IGAxBSA score relative to vehicle was 47.3% compared with 34.2% for HP plus TAZ (ratio 1.4). HP/TAZ lotion also provided synergistic benefits in terms of achieving a clinically meaningful outcome, with a ratio of 1.3 and 2.0 at weeks 8 and 12.

CONCLUSIONS: Halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) fixed combination lotion provides a synergistic benefit in the treatment of moderate-to-severe plaque psoriasis. In addition, by combining two agents into one once-daily formulation, this novel formulation reduces the number of product applications and may help patient adherence.

J Drugs Dermatol. 2019;18(3):279-284.

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INTRODUCTION

Combination therapy in dermatology is very common, often used with the aim to provide enhanced efficacy, minimize the side effects from the individual active ingredients, and provide patient adherence benefits. A novel fixed combination topical agent for the treatment of moderate-to-severe plaque psoriasis containing halobetasol propionate (0.01%) and tazarotene (0.045%) has recently been developed. Clinical data on 8 weeks’ once-daily treatment showed halobetasol propionate/tazarotene (HP/TAZ) lotion to be significantly more effective than individual active ingredients or vehicle in improving disease severity and the signs and symptoms of psoriasis at the target lesion.1,2The rationale behind the development of HP/TAZ lotion was to provide an optimal topical treatment for moderate-to-severe psoriasis: providing synergistic efficacy, reducing or minimizing the irritant effect of tazarotene and the local cutaneous adverse events (AEs) with halobetasol (such as skin atrophy,

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