title: Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study.
abstract: BACKGROUND
  Fixed-combination calcipotriol 50 μg/g plus betamethasone 0.5 mg/g (Cal/BD) aerosol foam is a new topical treatment for psoriasis. Although moderate-to-severe psoriasis is typically treated with systemic/biologic therapies, a topical treatment that is efficacious in these patients may be a significant cost-saving alternative to systemic therapy.
  
  
  OBJECTIVE
  The objective of this study was to assess the response to Cal/BD foam and gel in patients with moderate-to-severe psoriasis enrolled in the phase III, 12-week PSO-ABLE study.
  
  
  METHODS
  Patients eligible for this analysis had moderate-to-severe psoriasis, defined by the 'Rule of Tens': body surface area ≥10% or Psoriasis Area and Severity Index (PASI) [excluding head; modified PASI (mPASI)] >10 or Dermatology Life-Quality Index >10. Endpoints included: proportion of patients achieving mPASI75 or mPASI90; change in body surface area; proportion of patients clear/almost clear with a ≥2 grade improvement (i.e., treatment success); change in Dermatology Life-Quality Index.
  
  
  RESULTS
  Seventy-seven Cal/BD foam patients and 82 gel patients had moderate-to-severe psoriasis. A greater proportion achieved mPASI75 and mPASI90 with Cal/BD foam than gel at weeks 4, 8, and 12 (57.1 vs. 35.4%; p = 0.006 and 15.6 vs. 12.2% at week 12, respectively); overall reduction in mPASI from baseline to week 12 was 64% with the foam vs. 51% with the gel. Overall reduction in body surface area at week 12 was 50% with the foam and 39% with the gel. Treatment success rates were higher with the Cal/BD foam than the gel at weeks 1, 2, 4, 8 (p = 0.0089), and 12, and a greater proportion of foam patients achieved a Dermatology Life-Quality Index score of 0/1 at weeks 4 (p = 0.004), 8, and 12 (p = 0.001).
  
  
  CONCLUSIONS
  Cal/BD foam can be considered as a treatment option in some patients with moderate-to-severe psoriasis who are potential candidates for systemic therapy. CLINICALTRIALS.
  NCT02132936.
authors.affiliation: Paul Sabatier University and Larrey Hospital, Toulouse, France.
authors.forename: Carle
authors.initials: C
authors.lastname: Paul
authors.affiliation: Saint Louis University School of Medicine, St. Louis, MO, USA.
authors.forename: Craig
authors.initials: C
authors.lastname: Leonardi
authors.affiliation: Baylor University Medical Center, Dallas, TX, USA.
authors.forename: Alan
authors.initials: A
authors.lastname: Menter
authors.affiliation: Dermatologikum Hamburg and SCIderm GmbH, Hamburg, Germany.
authors.forename: Kristian
authors.initials: K
authors.lastname: Reich
authors.affiliation: Henry Ford Health System, Detroit, MI, USA.
authors.forename: Linda Stein
authors.initials: LS
authors.lastname: Gold
authors.affiliation: The Dermatology Centre, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
authors.forename: Richard B
authors.initials: RB
authors.lastname: Warren
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: Anders
authors.initials: A
authors.lastname: Møller
authors.affiliation: Department of Dermatology, Icahn School of Medicine at Mount Sinai, 5 E 98th St, New York, NY, 10029, USA. lebwohl@aol.com.
authors.forename: Mark
authors.initials: M
authors.lastname: Lebwohl
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000336:Aerosols; D000368:Aged; D001623:Betamethasone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002117:Calcitriol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004338:Drug Combinations; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000336:Aerosols; D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D002117:Calcitriol