The Aerosol Foam Formulation of the Fixed Combination Calcipotriene Plus Betamethasone Dipropionate Improves the Health-Related Quality of Life in Patients With Psoriasis Vulgaris: Results from the Randomized PSO-FAST Study

August 2016 | Volume 15 | Issue 8 | Original Article | 981 | Copyright © August 2016


Craig Leonardi MD,a Jerry Bagel MD,b Paul Yamauchi MD,c David Pariser MD,d Zhenyi Xu MD,e Anders Møller MSc,e Marie Louise Østerdal MSc,e and Linda Stein Gold MDf

aDepartment of Dermatology, Saint Louis University School of Medicine, St Louis, MO
bPsoriasis Treatment Center of Central New Jersey, East Windsor, NJ
cDivision of Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, CA
dDepartment of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, VA
eLEO Pharma A/S, Ballerup, Denmark
fHenry Ford Health System, Detroit, MI

Abstract
INTRODUCTION: Psoriasis has a major impact on patient quality of life, similar to that seen in other chronic diseases, eg, diabetes. Health-related quality of life (HRQoL) measures are commonly included in clinical trial designs, capturing the disease burden and therapeutic success of a treatment. In the randomized, double-blind, phase III PSO-FAST (Psoriasis vulgaris, a Four-week, vehicle-controlled, efficacy And Safety Trial) study (nCT01866163), fixed combination calcipotriene (Cal) 0.005% plus betamethasone dipropionate (BD) 0.064% aerosol foam was compared with vehicle. By treatment end, 53% of patients using Cal/BD foam achieved treatment success.
OBJECTIVE: To compare the impact on HRQoL of Cal/BD foam vs vehicle in patients with mild-to-severe psoriasis.
METHOD: HRQoL was assessed by dermatology life-quality index (DLQI; baseline, weeks 1, 2, 4) and EQ-5D-5L (EQ-5D; baseline, week 4) questionnaires. A DLQI score of 0 (range, 0–30) indicates no effect on the patient’s life; an EQ-5D utility score of 1 (range, 0–1) and an EQ-5D visual analog scale (VAS) score of 100 (range, 1–100) indicate perfect health.
RESULTS: 426 patients were randomized (Cal/BD foam, n=323; vehicle, n=103). Baseline mean DLQI scores were 9.9 (Cal/BD foam) and 10.3 (vehicle). The impact of psoriasis on HRQoL (EQ-5D utility score) at baseline was primarily driven by pain/discomfort (Cal/BD foam: 69.9%; vehicle: 65.0%) and anxiety/depression (Cal/BD foam: 45.3%; vehicle 44.7%). There was a greater improvement from baseline in DLQI score for Cal/BD foam vs vehicle at week 4 (–7.0 vs –4.4; P<.001); increased improvement was also seen in EQ-5D scores. At week 4, 48.1% of patients using Cal/BD foam reported no effect of psoriasis on their lives (DLQI = 0/1), and of patients using Cal/BD foam with baseline DLQI scores ≥5, 81.2% achieved a ≥5-point improvement.
CONCLUSION: Cal/BD aerosol foam improved HRQoL after 4 weeks, with most patients experiencing a clinically meaningful improvement and almost 50% reporting no impairment.

J Drugs Dermatol. 2016;15(8):981-987.

INTRODUCTION

Psoriasis is a chronic inflammatory disorder characterized by itchy, scaly erythematous plaques on the skin.1,2 The presence of plaques on visible areas of the body can lead to considerable psychological stress and psychosocial disability, with acute feelings of stigmatization.3 Patients have reported that psoriasis reduces their self-esteem and emotional well-being, and that it can adversely affect social interactions and intimate relationships.4,5 As such, determining the burden of psoriasis on the patient is not simply a case of measuring disease severity.6 Health-related quality of life (HRQoL) measures are increasingly used in clinical trials to provide a better overall picture of the burden of the disease. For example,the dermatology life-quality index (DLQI)7 is most often used as an indicator of changes in HRQoL during psoriasis treatment. The EQ-5D-5L (EQ-5D) HRQoL measure, which is a generic, non-disease-specific index, is also commonly used, and allows clinical experts and reimbursement authorities to compare the impact of psoriasis on HRQoL with that of other diseases.8 EQ-5D data from previous studies indicate that the disutility in the HRQoL of patients with psoriasis is within the range of diseases such as diabetes, cardiovascular diseases, and cancer.9-11
For most patients with psoriasis, topical therapies are the first-line treatment of choice.12,13 An alcohol-free aerosol foam
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