Desoximetasone 0.25% Spray for the Relief of Scaling in Adults With Plaque Psoriasis
August 2015 | Volume 14 | Issue 8 | Original Article | 835 | Copyright © August 2015
Brian Robert Keegan MD PhD
Windsor Dermatology and Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ
Abstract
Data from two Phase 3, double-blind, randomized, vehicle-controlled parallel studies were evaluated to determine the efficacy and safety of twice daily desoximetasone 0.25% spray for the treatment of plaque psoriasis. In addition to global disease assessments, scaling assessments were performed at baseline and at weeks 1, 2, and 4.
To qualify for inclusion, subjects were required to have a clinical diagnosis of stable plaque psoriasis involving ≥10% of the body surface area (BSA), a combined target lesion severity score (TLSS) of ≥7 for the target lesion, a plaque elevation score of ≥3 (moderate) for the target lesion, and a Physician Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.
At the baseline visit, the mean proportions of BSA affected by psoriasis were 17% (range 10% to 86%) in the desoximetasone 0.25% spray group and 16% (range 10% to 70%) in the vehicle spray group. Approximately 90% of the patients in each group had moderate to very severe scaling at baseline. Desoximetasone 0.25% spray was effective with significant improvements in overall severity and was well tolerated, with dryness, irritation, and pruritus at the application site being the only reported adverse events occurring in >1% of patients, each of which occurred in less than 3% of patients.
As a large proportion of psoriasis patients (94%) have reported being bothered by scaling, the relief of scaling was examined in these studies. At week 1, 69.7% of patients on desoximetasone 0.25% spray had scaling that was considered clear / almost clear / mild compared with 48.3% for those on vehicle spray (
P= .0027). By week 4, the proportion of patients with clear / almost clear / mild scaling had risen to 83.9% in the desoximetasone 0.25% spray group (
P < .0001). After four weeks of treatment, 66.4% of patients in the topical corticosteroid group had an overall improvement of at least two grades of disease severity. This demonstrates that desoximetasone 0.25% spray provided fast and effective relief of scaling in patients with plaque psoriasis affecting 10% to 86% of their BSA.
J Drugs Dermatol. 2015;14(8):835-840.
INTRODUCTION
Plaque psoriasis is a chronic, inflammatory disease of the skin characterized by a wide array of symptoms such as scaling, itching, redness, and pain.1-3 A survey of 10,676 adults in the United States estimated the prevalence at 3.1% with nearly 7 million
adults ≥20 years of age being affected by the disorder.1
The quality of life for patients with moderate to severe psoriasis
can be adversely affected by their disease.3 There is a significant correlation between the severity of the disease and its impact on daily life (P = .0001).1 One survey of 6,194 patients with severe disease reported that 79% of respondents thought their disease had a negative effect on their lives and 40% were frustrated with the ineffectiveness of their current therapies.2 Several psychological and sociological comorbidities have been associated with psoriasis including depression,4,5 anxiety,
5 decreased productivity,3 suicidal tendancies,5 metabolic syndrome,6 smoking,7 and alcohol use.8 Another survey from the National Psoriasis Foundation of over 17,000 respondents with psoriasis found the most commonly reported bothersome
symptom (reported by 94%) was scaling.2
There is currently no cure for plaque psoriasis; therefore, the goal of treatment is to provide symptom relief.9,10 Topical corticosteroids
are considered mainstays of psoriasis treatment either as primary treatment or when added to a systemic agent or phototherapy.10,11 With adherence to prescribing instructions, noticeable improvement can be seen in as little as one week of therapy, although the full benefits may require several weeks of treatment.
Topical corticosteroids affect genetic transcription and thus provide anti-inflammatory, immunosuppressive, and antiproliferative
actions.10 Desoximetasone 0.25% spray is a super-potent topical corticosteroid.12,13 Two Phase 3 studies were conducted to compare the efficacy and safety of desoximetasone
0.25% spray to a vehicle spray for the treatment plaque psoriasis. Results from these studies led to the FDA approval of desoximetasone 0.25% spray for the treatment of plaque psoriasis. Overall disease severity data have been previously published.14,15 Results for the relief of scaling are presented herein.
