Safety and efficacy of a fixed combination of halobetasol and tazarotene in the treatment of moderate-to-severe plaque psoriasis: Results of 2 phase 3 randomized controlled trials - 16/07/18
, Mark G. Lebwohl, MD b, Jeffrey L. Sugarman, MD, PhD c, David M. Pariser, MD d, Tina Lin, PharmD e, Gina Martin, MOT f, Radhakrishnan Pillai, PhD f, Robert Israel, MD g, Tage Ramakrishna, MD gAbstract |
Background |
Topical corticosteroids are the mainstay of psoriasis treatment, with long-term safety considerations limiting their use. Combining them with tazarotene may optimize their efficacy and minimize safety and tolerability concerns.
Objective |
To investigate the safety and efficacy of halobetasol propionate 0.01% plus tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis.
Methods |
Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N = 418) were conducted. Subjects were randomized (2:1) to HP/TAZ lotion or vehicle once daily for 8 weeks with a 4-week follow-up. The primary efficacy assessment end point was treatment success (at least a 2-grade improvement from baseline in Investigator's Global Assessment score and a score of clear or almost clear). Safety and treatment-emergent adverse events were evaluated throughout.
Results |
HP/TAZ lotion demonstrated statistically significant superiority over vehicle within as few as 2 weeks. By week 8, 35.8% (study 1) and 45.3% (study 2) of subjects were treatment successes compared with 7.0% and 12.5% of those treated with vehicle (P < .001). HP/TAZ lotion was also superior in reducing signs and symptoms of psoriasis and body surface area affected by psoriasis. The most frequently reported treatment-related adverse events were contact dermatitis (6.3%), application site pain (2.6%), and pruritus (2.2%).
Limitations |
Studies did not include subjects with more than 12% of their body surface area affected by psoriasis.
Conclusions |
HP/TAZ lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, with no safety concerns.
Le texte complet de cet article est disponible en PDF.Key words : fixed combination, halobetasol, psoriasis, tazarotene, topical
Abbreviations used : AE, BSA, DLQI, HP/TAZ, IGA, QoL, TCS
Plan
| The trial was neither carried out at University of California, San Francisco (UCSF) nor evaluated by UCSF's Institutional Review Board. |
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| Funding sources: Supported by Dow Pharmaceutical Sciences, Inc, a division of Valeant Pharmaceuticals North America LLC. The fees for the editorial assistance provided by Konic Ltd were paid by Valeant Pharmaceuticals North America LLC. |
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| Disclosure: Dr Gold is an adviser, consultant, and speaker for Valeant Pharmaceuticals. Dr Lebwohl is an employee of Mount Sinai, which receives research funds from Abbvie, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Incyte, Johnson and Johnson, Leo, Medimmune/AstraZeneca, Novartis, Pfizer, Sciderm, Valeant, and ViDac, and he is a consultant for Allergan, Aqua, Dr Reddy's Laboratories, and Leo. Dr Sugarman is an adviser or speaker for Valeant, Pfizer, and Promius. Dr Pariser is a consultant, investigator, or adviser for Bickel Biotechnology, Biofrontera, Celgene, Dermira, DUSA Pharmaceuticals, Leo, Novartis, Pfizer, Promius, Regeneron, Sanofi, TherVida, Valeant, Abbott, Asana Biosciences, Dermavant, Eli Lilly and Company, Merck, Novo Nordisk, Ortho Dermatologics, Peplin, Photocure, and Steifel. Dr Lin, Ms Martin, Dr Pillai, Dr Israel, and Dr Ramakrishna are employees of Valeant Pharmaceuticals. |
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| QST Consultations, Ltd, performed statistical analysis. The authors vouch for the accuracy of the data, analysis, and fidelity of each study to the protocols. They were involved in the writing of sections of the first draft of the manuscript, which were combined and reviewed by all, with editorial assistance provided by Konic Ltd. All the authors agreed to submit the manuscript for publication. |
Vol 79 - N° 2
P. 287-293 - août 2018 Retour au numéro
Article précédent
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