Long‐term safety and efficacy of a fixed‐combination halobetasol propionate 0.01%/tazarotene 0.045% lotion in moderate‐to‐severe plaque psoriasis: phase 3 open‐label study

• Published in: Journal of the European Academy of Dermatology and Venereology Vol. 35; no. 5; pp. 1152 - 1160
• Main Authors: Lebwohl, M.G., Stein Gold, L., Papp, K., Han, G., Pariser, D.M., Lin, T., Harris, S., Jacobson, A.
• Format: Journal Article
• Language: English
• Published: England 01.05.2021
• Subjects: Administration, Cutaneous; Adult; Clobetasol - analogs & derivatives; Dermatologic Agents - adverse effects; Double-Blind Method; Drug Combinations; Humans; Nicotinic Acids; Propionates - therapeutic use; Psoriasis - drug therapy; Severity of Illness Index; Skin Cream; Treatment Outcome
• ISSN: 0926-9959; 1468-3083
• DOI: 10.1111/jdv.17113

Background The topical corticosteroid halobetasol propionate (HP) and the retinoid tazarotene (TAZ) are effective in psoriasis treatment. To mitigate adverse cutaneous reactions observed with monotherapy, a fixed‐ combination HP 0.01%/TAZ 0.045% lotion has been developed for the treatment of plaque psoriasis in adults. Objectives To investigate the long‐term safety, efficacy and maintenance of response with HP/TAZ lotion. Methods This was a 1‐year, multicentre, open‐label study in 555 adults with psoriasis [Investigator's Global Assessment (IGA) score of 3 (‘moderate’) or 4 (‘severe’) and body surface area (BSA) of 3–12% at baseline]. HP/TAZ was administered once daily for 8 weeks and then intermittently as needed in 4‐week intervals for up to 1 year based on achievement of treatment success [IGA score of 0 (‘clear’) or 1 (‘almost clear’)]. Maximum continuous exposure was 24 weeks. Results Of 550 participants with postbaseline safety data, 318 (57.8%) achieved treatment success during the study. Of those, 54.4% achieved treatment success within the first 8 weeks; retreatment was not required for >4 weeks in over half (55.3%), and 6.6% did not require any retreatment. Among participants enrolled for the full 52 weeks, 77.5% maintained BSA ≤5% on treatment. There were marked improvements in severity of itching, dryness and burning/stinging over the study course. The most common treatment‐related adverse events were application site reactions of dermatitis, pruritus, pain and irritation. Conclusions Fixed‐combination HP/TAZ lotion provided maintained efficacy with a favourable tolerability and safety profile, supporting its use for the long‐term treatment and management of moderate‐to‐severe plaque psoriasis.