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Impact of Clobetasol Propionate 0.05% Spray on Health-Related Quality of Life in Patients With Plaque Psoriasis

November 2012 | Volume 11 | Issue 11 | 1348 | Copyright © November 2012


M. Alan Menter MD,a Scott W. Caveney MD PhD,b and Ronald W. Gottschalk MDb

aBaylor Psoriasis Research Center (Baylor Research Institute), Baylor University Medical Center, Dallas, TX bGalderma Laboratories, L.P., Fort Worth, TX

Abstract
Psoriasis causes significant distress and impairment in health-related quality of life (QOL) in afflicted patients. For this reason, QOL is an essential and important measure of treatment outcome in patients with the disease. Clobetasol propionate is a super-highpotent class I topical corticosteroid. The spray formulation is approved for twice-daily use for up to 4 weeks by patients 18 years and older with moderate to severe plaque psoriasis. Data collected from 2,236 patients enrolled in 5 clinical trials demonstrate consistent improvement in QOL measures using multiple instruments. In a randomized, double-blind trial in patients with scalp psoriasis, treatment with clobetasol propionate 0.05% spray produced significantly greater improvement in QOL compared with vehicle, as measured by the Scalpdex QOL instrument. In another randomized trial in patients with moderate to severe plaque psoriasis, clobetasol propionate 0.05% spray produced significantly greater reductions in mean affected body surface area and significantly greater improvements in QOL, as measured by the Dermatology Life Quality Index (DLQI), compared with a 0.05% foam formulation. When compared with calcipotriene/betamethasone dipropionate ointment, clobetasol propionate 0.05% spray produced greater rates of lesion clearance and similar improvement in QOL scores after 2 or 4 weeks of treatment. When clobetasol propionate 0.05% spray was used as monotherapy or as an add-on therapy for 4 weeks in a large, observational trial, approximately 80% of patients experienced consistent and significant improvement in QOL on 2 separate, validated QOL instruments (DLQI and the Koo-Menter Psoriasis Index). In conclusion, clobetasol propionate 0.05% spray is an efficacious and safe treatment for plaque psoriasis and produces significant improvement in QOL for affected patients.

J Drugs Dermatol. 2012;11(11):1348-1354.

INTRODUCTION

Psoriasis is a highly visible skin disease, affecting approximately 2% to 3% of the U.S. population. It causes significant psychological and social distress and impairs health-related quality of life (HRQOL).1-3 Psoriatic lesions are painful, uncomfortable, and even debilitating, with significant interference in patients' personal relationships and sexual activitiy. 4-7 The disease affects body image and self-esteem and causes shame and embarrassment for many individuals.8,9 Large surveys conducted in the United States and Europe have shown that approximately 80% of patients with psoriasis feel that the disease has a negative impact on their lives.4,10
Psoriasis can impose a substantial burden, even in those whose disease is not extensive.11 The degree of impairment in QOL associated with psoriasis is significant compared with U.S. population norms and is apparent on all subscales of the Short Form 36 Health Survey (SF-36) questionnaire.2 Although the condition in the majority of patients is not life threatening, the impairment in the physical and mental components of QOL as measured by the SF-36 in patients with psoriasis is comparable or even worse than seen in patients with cancer, arthritis, heart disease, depression, and other serious chronic medical conditions.2
Some studies have detected a correlation between disease severity and impairment of QOL.2,4 For example, a survey of 317 patients with mild to severe disease showed that the severity of psoriasis lesions, as rated by the self-administered Psoriasis Area and Severity Index, was significantly correlated with the extent of impairment in the physical and mental components of QOL, as measured by the SF-36.2
In contrast, a study that was limited to patients with moderate to severe plaque psoriasis showed that lesions located on visible body parts had a significant impact on QOL, but that the overall disease severity did not correlate with impairment in QOL, as measured by the SF-36 instrument.12
Work limitation and productivity loss are more strongly linked to QOL than to disease severity in patients with psoriasis.13,14 In a study of work productivity and QOL in 201 German patients with mild to severe psoriasis, most of whom (59%) were using topical therapy to manage their condition, there was only a weak correlation between the extent and severity of lesions and work productivity.13 In contrast, there was a strong and statistically significant correlation between impairment in QOL and reductions in work productivity.13 Similar findings were obtained in a study conducted in 273 patients in Sweden and Finland. Patients who were less satisfied with their treatment tended to have more severe disease and lower QOL; however, work productivity was more strongly correlated with QOL than with disease severity.14
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