title: Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study.
abstract: Fixed combination calcipotriol 50 μg/g (Cal) plus betamethasone 0.5 mg/g (BD) foam has been developed as a new treatment option for patients with psoriasis.
  
  
  
  The randomized, parallel-group, investigator-blinded Phase III, 12-week PSO-ABLE study compared the efficacy and safety of Cal/BD foam with Cal/BD gel. Patients aged ≥18 years with mild-to-severe psoriasis were randomized 4:4:1:1 to once-daily Cal/BD foam, Cal/BD gel, foam vehicle or gel vehicle (NCT02132936). The primary efficacy endpoint was the proportion of patients who were clear/almost clear with a ≥ 2 grade improvement according to the physician's global assessment of disease severity (i.e. treatment success) at week 4 for Cal/BD foam vs. week 8 for Cal/BD gel. Secondary efficacy endpoints included: proportion of patients achieving at least a 75% reduction in modified psoriasis area and severity index (mPASI75), and time to treatment success (TTTS). Safety was monitored throughout.
  
  
  
  A total of 463 patients were randomized: Cal/BD foam (n = 185), Cal/BD gel (n = 188), foam vehicle (n = 47), gel vehicle (n = 43); overall completion rate was 90%. Cal/BD foam achieved higher treatment success rates (38% vs. 22%; P < 0.001) and mPASI75 (52% vs. 35%; P < 0.001) by week 4 than Cal/BD gel by week 8. Median TTTS with Cal/BD foam was 6 weeks; this could not be determined for Cal/BD gel as 50% treatment success was not achieved (P < 0.001). Adverse drug reactions were reported in 14 (7.6%) Cal/BD aerosol foam patients and 7 (3.7%) Cal/BD gel patients; all were single events except for itch with Cal/BD aerosol foam (n = 5; 2.7%) and worsening psoriasis with Cal/BD gel (n = 3; 1.6%).
  
  
  
  Cal/BD aerosol foam showed significantly greater efficacy after 4 weeks, than 8 weeks of treatment with Cal/BD gel, with similar tolerability.
authors.affiliation: Paul Sabatier University and Larrey Hospital, Toulouse, France.
authors.forename: C
authors.initials: C
authors.lastname: Paul
authors.affiliation: Henry Ford Health System, Detroit, MI, USA.
authors.forename: L
authors.initials: L
authors.lastname: Stein Gold
authors.affiliation: Jean Monnet University, Saint-Etienne, France.
authors.forename: F
authors.initials: F
authors.lastname: Cambazard
authors.affiliation: State University of New York, Buffalo, NY, USA.
authors.forename: R E
authors.initials: RE
authors.lastname: Kalb
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: D
authors.initials: D
authors.lastname: Lowson
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: B
authors.initials: B
authors.lastname: Bang
authors.affiliation: Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester, UK.
authors.forename: C E M
authors.initials: CE
authors.lastname: Griffiths
mesh_terms: D000328:Adult; D000336:Aerosols; D001623:Betamethasone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002117:Calcitriol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*
chemical_list: D000336:Aerosols; D005782:Gels; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D002117:Calcitriol