Clinical therapeutics · 2025
A Canadian Real-World Study of Fixed-DOSE combination of Halobetasol Propionate 0.01%/Tazarotene 0.045% Lotion for the Treatment of Moderate-to-Severe Plaque Psoriasis.
СтатьяМногоцентровое исследованиеКлиническое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Vender R, Lynde C, Prajapati V, Zeinab R, Legault M, Hong Hc-H, Barakat M
Аннотация
BACKGROUND: A fixed-dose combination of HP/TAZ has demonstrated efficacy with a favorable safety profile for treating moderate-to-severe plaque psoriasis.
OBJECTIVE: The present single-arm, open-label study evaluated the use of HP/TAZ in real-world practice.
METHODS: Adults with moderate-to-severe psoriasis were enrolled and treated with HP/TAZ according to the Canadian label. The primary endpoint was the percentage of patients with treatment success at week 8, defined as an Investigator's Global Assessment score of clear or almost clear with a minimum 2-grade improvement.
RESULTS: 202 patients received at least one dose of HP/TAZ, 138 patients had efficacy assessments at baseline and week 8. Treatment success was achieved by 26.1% and 43.5% of patients (week 4 and 8 respectively) . Patient-rated average and worst itch were 4.5 and 5.3 points at baseline, with a subsequent reduction to 1.7 and 2.1 points, respectively, at week 8. Patients were satisfied-very satisfied with the HP/TAZ. Application site reactions (13.4%) and dermatitis/eczema (3.5%) were the most frequently reported adverse events (mild-moderate in severity) .
LIMITATIONS: The study design may limit generalizability of the results as an open label real world evidence study lacking a placebo or comparator arm.
CONCLUSION: Results confirm that HP/TAZ can be beneficial moderate-to-severe psoriasis patients.
OBJECTIVE: The present single-arm, open-label study evaluated the use of HP/TAZ in real-world practice.
METHODS: Adults with moderate-to-severe psoriasis were enrolled and treated with HP/TAZ according to the Canadian label. The primary endpoint was the percentage of patients with treatment success at week 8, defined as an Investigator's Global Assessment score of clear or almost clear with a minimum 2-grade improvement.
RESULTS: 202 patients received at least one dose of HP/TAZ, 138 patients had efficacy assessments at baseline and week 8. Treatment success was achieved by 26.1% and 43.5% of patients (week 4 and 8 respectively) . Patient-rated average and worst itch were 4.5 and 5.3 points at baseline, with a subsequent reduction to 1.7 and 2.1 points, respectively, at week 8. Patients were satisfied-very satisfied with the HP/TAZ. Application site reactions (13.4%) and dermatitis/eczema (3.5%) were the most frequently reported adverse events (mild-moderate in severity) .
LIMITATIONS: The study design may limit generalizability of the results as an open label real world evidence study lacking a placebo or comparator arm.
CONCLUSION: Results confirm that HP/TAZ can be beneficial moderate-to-severe psoriasis patients.