Original Research

Safety and Efficacy of Halobetasol Propionate Lotion 0.01% in the Treatment of Moderate to Severe Plaque Psoriasis: A Pooled Analysis of 2 Phase 3 Studies

Cutis. 2019 February;103(2):111-116, E1-E3

Jeffrey L. Sugarman, MD, PhD

Jonathan S. Weiss, MD

Emil A. Tanghetti, MD

Jennifer Soung, MD

Paul S. Yamauchi, MD

Tina Lin, PharmD

Susan Harris, MS

Gina Martin, MOT

Radhakrishnan Pillai, PhD

Dr. Sugarman is from the University of California, San Francisco. Dr. Weiss is from Gwinnett Dermatology, PC, and Gwinnett Clinical Research Center, Inc, Snellville, Georgia. Dr. Tanghetti is from the Center for Dermatology and Laser Surgery, Sacramento, California. Dr. Soung is from Southern California Dermatology, Santa Ana. Dr. Yamauchi is from the David Geffen School of Medicine at UCLA, Los Angeles, California. Dr. Lin is from Ortho Dermatologics, Bridgewater, New Jersey. Ms. Harris is from Bausch Health, Bridgewater. Ms. Martin and Dr. Pillai are from Bausch Health, Petaluma, California.

Dr. Sugarman is an advisor and investigator for Bausch Health. Dr. Weiss is a consultant and investigator for Ortho Dermatologics. Dr. Tanghetti is a speaker for AbbVie; Eli Lilly and Company; Galderma Laboratories, LP; LEO Pharma; Ortho Dermatologics; Novartis; and Sun Pharmaceutical Industries, Ltd. He also is an advisory board member for Galderma Laboratories, LP; an advisory board member and investigator for Ortho Dermatologics; and an investigator for LEO Pharma and Novartis. Dr. Soung has received honoraria and/or research grants from and is on the speakers bureau for AbbVie, Amgen Inc, Celgene Corporation, Eli Lilly and Company, Novartis, and Ortho Dermatologics; on the advisory board for Eli Lilly and Company; an investigator for AbbVie and Ortho Dermatologics; and an investigator and consultant for Novartis. She also is an investigator and has received research grants and/or honoraria from Boehringer Ingelheim; GlaxoSmithKline; Janssen Biotech, Inc; Kadmon Corporation; Pfizer Inc; and UCB. Dr. Yamauchi is a consultant, investigator, and speaker for Ortho Dermatologics. Dr. Lin is an employee and stockholder of Ortho Dermatologics. Ms. Harris and Ms. Martin are employees of Bausch Health. Dr. Pillai holds patents from Bausch Health.

These studies were registered at ClinicalTrials.gov with the identifiers NCT02514577 and NCT02515097.

The eFigures and eTables are available in the Appendix.

Correspondence: Jeffrey L. Sugarman, MD, PhD, Redwood Dermatology Research, 2725 Mendocino Ave, Santa Rosa, CA 95403 (pediderm@yahoo.com).

Potent topical corticosteroids (TCSs) are the mainstay of psoriasis treatment. Safety concerns have limited use to 2 to 4 weeks. The objective of our study was to investigate the safety and efficacy of once-daily halobetasol propionate (HP) lotion 0.01% in moderate to severe plaque psoriasis through 2 multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Participants were randomized (2:1) to HP lotion 0.01% or vehicle once daily for 8 weeks, followed by 4 weeks of follow-up. The primary efficacy assessment was treatment success (at least a 2-grade improvement in baseline investigator global assessment [IGA] score and a score of 0 [clear] or 1 [almost clear]). Additional assessments included improvement in psoriasis signs and symptoms, body surface area (BSA), and a composite score of IGA×BSA. Safety and treatment-emergent adverse events (AEs) were evaluated throughout. We found that HP lotion 0.01% demonstrated statistically significant superiority over vehicle as early as week 2 and also was superior in reducing psoriasis signs and symptoms and BSA involvement.

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References

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Ultravate [package insert]. Jacksonville, FL: Ranbaxy; 2012.

Psoriasis is a chronic, immune-mediated, inflammatory disease affecting almost 2% of the population.^1-3 It is characterized by patches of raised reddish skin covered by silvery-white scales. Most patients have limited disease (<5% body surface area [BSA] involvement) that can be managed with topical agents.⁴ Topical corticosteroids (TCSs) are considered first-line therapy for mild to moderate disease because of the inflammatory nature of the condition and often are used in conjunction with systemic agents in more severe psoriasis.⁴

As many as 20% to 30% of patients with moderate to severe plaque psoriasis have inadequate disease control.⁵ Several factors may affect patient outcomes; however, drug selection and patient adherence are important given the chronic nature of the disease. A survey of 1200 patients with psoriasis reported nonadherence rates of 73% with topical therapy.⁶ In addition, patients tend to apply less than the recommended dose or abandon treatment altogether if rapid improvement does not occur^7,8; it is not uncommon for patients with psoriasis to mistakenly believe treatment will improve their condition within 1 to 2 weeks.⁹ Patient satisfaction with topical treatments is low, partly because of these false expectations and formulation issues. Treatments can be greasy and sticky, with unpleasant odors and the potential to stain clothes and linens.^7,10 Safety concerns with TCSs also limit their consecutive use beyond 2 to 4 weeks, which is not ideal for a disease that requires a long-term management strategy.

A potent/superpotent TCS that is administered once daily and has a safety profile that affords longer-term, once-daily treatment in an aesthetically pleasing formulation would seem ideal. Herein, we investigate the safety and tolerability of a novel low-concentration (0.01%) lotion formulation of halobetasol propionate (HP), reporting on the pooled data from 2 phase 3 clinical studies in participants with moderate to severe psoriasis.

METHODS
Study Design

We conducted 2 multicenter, double-blind, randomized, parallel-group phase 3 studies to assess the safety, tolerability, and efficacy of HP lotion 0.01% in participants with a clinical diagnosis of moderate to severe psoriasis with an investigator global assessment (IGA) score of 3 or 4 and an affected BSA of 3% to 12%. Participants were randomized (2:1) to receive HP lotion or vehicle applied topically to the affected area once daily for 8 weeks.

Safety and Efficacy of Halobetasol Propionate Lotion 0.01% in the Treatment of Moderate to Severe Plaque Psoriasis: A Pooled Analysis of 2 Phase 3 Studies

References

METHODSStudy Design

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METHODS
Study Design