Halobetasol 0.01%/Tazarotene 0.045% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: Maintenance of Therapeutic Effect After Cessation of Therapy
July 2018 | Volume 17 | Issue 7 | Original Article | 723 | Copyright © July 2018
David M. Pariser MD,a Lawrence J. Green MD,b Linda Stein Gold MD,c Jeffrey L. Sugarman MD PhD,d Tina Lin PharmD,e Radhakrishnan Pillai PhDf
aVirginia Clinical Research, Inc., Norfolk, VA bDepartment of Dermatology, Temple University School, Philadelphia, PA cHenry Ford Hospital, Detroit, MI dUniversity of California, San Francisco, CA eOrtho Dermatologics, Bridgewater, NJ fDow Pharmaceutical Sciences Inc. (a division of Valeant Pharmaceuticals, North America LLC), Petaluma, CA
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 posttreatment flare 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 minimize posttreatment flare or rebound. 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 its active ingredients and vehicle in patients with moderate-to-severe plaque psoriasis. Methods: Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study in moderate or severe psoriasis (N=212). Patients randomized (2:2:2:1 ratio) to receive HP/TAZ, individual active ingredients, 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’), and impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion. Results: At the end of the 4-week posttreatment period, 38.2% of patients who had been treated with HP/TAZ were treatment successes; compared with 21.0%, 12.8% and 6.9% of patients who had been treated with HP (P=0.042), TAZ (P=0.004), or vehicle (P=0.002). HP/TAZ lotion was also superior in maintaining reductions in psoriasis signs of erythema, plaque elevation, and scaling at the target lesion. At the end of the 4-week posttreatment period, 49.1%, 54.5%, and 54.5% of patients, respectively, were treatment successes: compared with 38.7% (P=0.26), 48.4% (P=0.51), and 48.4% (P=0.51) of patients who had been treated with HP; 29.8% (P=0.049), 31.9% (P=0.022), and 23.4% (P=0.001) who had been treated with TAZ; and 13.8% (P=0.002), 20.7% (P=0.003), and 20.7% (P=0.003) who had been treated with vehicle. Side effects were minimal and tended to resolve during the posttreatment period. Conclusions: In conclusion, HP 0.01%/TAZ 0.045% lotion provides synergistic efficacy following 8 weeks’ therapy that is sustained after a 4-week posttreatment period.
J Drugs Dermatol. 2018;17(7):723-726.
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INTRODUCTION
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 safety concerns due to increased risk of cutaneous tolerability generally limit approved use to 2-4 consecutive weeks.5,6 Data on maintenance of efficacy posttreatment are sparse. Topical tazarotene has also been shown to be effective in controlling signs and symptoms of plaque psoriasis,7 with lower predicted posttreatment relapse rates than fluocinonide cream.8 However, low efficacy and skin-associated events, such as pruritus, burning, and erythema are common and can limit their use.9Clinical studies have shown the added benefits of TCS as adjunctive therapy with tazarotene in the treatment of plaque psoriasis in terms of enhanced efficacy and tolerability.10,11 In addition, the superiority of TCS plus tazarotene over TCS monotherapy was sustained throughout the 12-week posttreatment period, with significant differences between the two treatment groups 4 weeks posttreatment.10
