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 (<b>Pso</b>riasis vulgaris, a <b>F</b>our-week, vehicle-controlled, efficacy <b>A</b>nd <b>S</b>afety <b>T</b>rial) 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><.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.<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.
RCT Entities:
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 (<b>Pso</b>riasis vulgaris, a <b>F</b>our-week, vehicle-controlled, efficacy <b>A</b>nd <b>S</b>afety <b>T</b>rial) 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: Siegfried Segaert; Neil H Shear; Andrea Chiricozzi; Diamant Thaçi; Jose-Manuel Carrascosa; Helen Young; Vincent Descamps Journal: Dermatol Ther (Heidelb) Date: 2017-08-07