TY - JOUR
T1 - Long-term safety and efficacy of a fixed-combination halobetasol propionate 0.01%/tazarotene 0.045% lotion in moderate-to-severe plaque psoriasis
T2 - phase 3 open-label study
AU - Lebwohl, M. G.
AU - Stein Gold, L.
AU - Papp, K.
AU - Han, G.
AU - Pariser, D. M.
AU - Lin, T.
AU - Harris, S.
AU - Jacobson, A.
N1 - Publisher Copyright:
© 2021 European Academy of Dermatology and Venereology
PY - 2021/5
Y1 - 2021/5
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85100531155&partnerID=8YFLogxK
U2 - 10.1111/jdv.17113
DO - 10.1111/jdv.17113
M3 - Article
C2 - 33428282
AN - SCOPUS:85100531155
SN - 0926-9959
VL - 35
SP - 1152
EP - 1160
JO - Journal of the European Academy of Dermatology and Venereology
JF - Journal of the European Academy of Dermatology and Venereology
IS - 5
ER -