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.

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.<BR />

OBJECTIVE:

To compare the impact on HRQoL of Cal/BD foam vs vehicle in patients with mild-to-severe psoriasis.<BR />

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.<BR />

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; <em>P</em>&lt;.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 &ge;5-point improvement.<BR />

CONCLUSION:

Cal/BD aerosol foam improved HRQoL after 4 weeks, with most patients experiencing a clinically meaningful improvement and almost 50% reporting no impairment.<br /><br /> <em>J Drugs Dermatol</em>. 2016;15(8):981-987.

• Authors: Craig Leonardi, Jerry Bagel, Paul Yamauchi, David Pariser, Zhenyi Xu, Anders Moller, Marie Louise Osterdal, Linda Stein Gold
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 15 Issue 8 Pg. 981-7 (Aug 01 2016) ISSN: 1545-9616 [Print] United States
• PMID: 27537999 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Aerosols
• Dermatologic Agents
• Drug Combinations
• calcipotriene
• betamethasone-17,21-dipropionate
• Betamethasone
• Calcitriol

Topics

• Adult
• Aerosols
• Betamethasone (administration & dosage, analogs & derivatives, chemistry)
• Calcitriol (administration & dosage, analogs & derivatives, chemistry)
• Dermatologic Agents (administration & dosage, chemistry)
• Double-Blind Method
• Drug Combinations
• Drug Compounding
• Female
• Health Status
• Humans
• Male
• Psoriasis (diagnosis, drug therapy)
• Quality of Life