Halobetasol 0.01%/Tazarotene 0.045% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: Maintenance of Therapeutic Effect After Cessation of Therapy

August 2019 | Volume 18 | Issue 8 | Original Article | 815 | Copyright © August 2019

Linda Stein Gold MD,ª Edward Lain MD,b Lawrence J. Green MD,c Tina Lin PharmD,d Robert Israel MDe

ªHenry Ford Hospital, Detroit, MI bAustin Institute for Clinical Research, Pflugerville, TX cTemple University School, Philadelphia, PA dOrtho Dermatologics, Bridgewater, NJ eBausch Health, Bridgewater, NJ

Abstract
Background: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Topical corticosteroids (TCS) are the mainstay of treatment. Long-term safety remains a concern, limiting use and recurrence is common. Tazarotene has also been shown to be effective in psoriasis, with efficacy maintained several weeks posttreatment. Fixed combination therapy with TCS and tazarotene may improve psoriasis signs and maintain efficacy between treatment sessions.

Objective: To investigate the maintenance of effect posttreatment with a once-daily application of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in comparison with vehicle in patients with moderate or severe plaque psoriasis.

Methods: Two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate or severe psoriasis (N=418). Patients randomized (2:1) to receive HP/TAZ lotion or vehicle, once-daily for 8 weeks with a 4 week posttreatment follow-up. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score, and ‘clear’ or ‘almost clear’), impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion, and maintenance of improvements in Body Surface Area (BSA), IGAxBSA and clinically meaningful benefit (IGAxBSA-75).

Results: At week 8, 40.7% of patients achieved treatment success with HP/TAZ lotion, compared with 9.9% treated with vehicle (P<0.001). Four weeks posttreatment, 33.3% of patients achieved treatment success. Two thirds of patients (63%) who were treatment successes at week 8 remained treatment successes posttreatment. In addition, up to 20% of patients who were not treatment successes at week 8 became treatment successes by the end of the study. Three-quarters of patients maintained BSA improvements or reported further reductions in BSA that seemed to be unrelated to baseline BSA severity. At the end of the 4 week posttreatment period, patients who had been treated with HP/TAZ lotion achieved a 46.6% reduction in IGAxBSA, compared with 7.9% on vehicle. 41.7% of patients achieved a clinically meaningful effect at week 8 and this was maintained posttreatment.

Limitations: The studies only had a 4 week follow-up period.

Conclusions: In conclusion, HP 0.01%/TAZ 0.045% lotion provides effective maintenance of efficacy over a 4 week posttreatment period.

J Drugs Dermatol. 2019;18(8):815-820.

INTRODUCTION

Psoriasis is a life-long disease with a chronic relapsing course, with most patients requiring long-term management. However, disease evolution is unpredictable, with the extent of skin involvement and time between episodes of recurrence wildly variable. Unlike other chronic inflammatory diseases receiving continuous treatment, psoriasis treatments are often used intermittently as the disease severity waxes and wanes. Topical therapy of psoriasis is commonplace, especially as most skin lesions are limited to localized areas such as the elbows and knees. Topical corticosteroids (TCS) are the most widely prescribed medications for plaque psoriasis in the United States. They are efficacious, generally well tolerated, and come in a variety of formulations.1 However, treatment success reported in clinical trials is highly variable,2-4 and their value is limited by poor long-term control,5 poor patient adherence and cutaneous side effects resulting from chronic use.6-9 Safety con