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
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.