Safety and Efficacy of Halobetasol Propionate Tazarotene Lotion for psoriasis

[Fred]

This phase 3 study investigate the long‐term safety, efficacy, and maintenance of response with halobetasol propionate (HP) and the retinoid tazarotene (TAZ)  lotion.

Quote:

---

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, multicenter, 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 post‐baseline 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 favorable tolerability and safety profile, supporting its use for the long‐term treatment and management of moderate‐to‐severe plaque psoriasis.

Source: onlinelibrary.wiley.com

*Early view funding unknown