title: 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: BACKGROUND
  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, aFour-week, vehicle-controlled, efficacyAndSafetyTrial) 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 />
  
  
  METHODS
  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 />
  
  
  CONCLUSIONS
  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.forename: Craig
authors.initials: C
authors.lastname: Leonardi
authors.forename: Jerry
authors.initials: J
authors.lastname: Bagel
authors.forename: Paul
authors.initials: P
authors.lastname: Yamauchi
authors.forename: David
authors.initials: D
authors.lastname: Pariser
authors.forename: Zhenyi
authors.initials: Z
authors.lastname: Xu
authors.forename: Anders
authors.initials: A
authors.lastname: Moller
authors.forename: Marie Louise
authors.initials: ML
authors.lastname: Osterdal
authors.forename: Linda
authors.initials: L
authors.lastname: Stein Gold
mesh_terms: D000328:Adult; D000336:Aerosols; D001623:Betamethasone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry; D002117:Calcitriol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000737:chemistry; D004311:Double-Blind Method; D004338:Drug Combinations; D004339:Drug Compounding; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D011565:Psoriasis / Q000175:diagnosis / Q000188:drug therapy*; D011788:Quality of Life
chemical_list: D000336:Aerosols; D003879:Dermatologic Agents; D004338:Drug Combinations; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D002117:Calcitriol