Real-life effectiveness of once-daily calcipotriol and betamethasone dipropionate gel vs. ointment formulations in psoriasis vulgaris: final analysis of the 52-week PRO-long study

J Eur Acad Dermatol Venereol. 2015 Dec;29(12):2349-55. doi: 10.1111/jdv.13230. Epub 2015 Sep 3.

Abstract

Background: Topical therapies are the mainstay of treatment for psoriasis vulgaris. The fixed combination of calcipotriol (Cal) 50 μg/g plus betamethasone 0.5 mg/g (as dipropionate; BD) is a first-line topical treatment and available as a gel or ointment. The use of these fixed combination products was compared in PRO-long, a long-term noninterventional study, for which interim results (4 and 12 weeks) have previously been reported.

Objective: To describe and compare patients' perspectives on the fixed combination gel and ointment formulations; to include efficacy, adherence behaviour, treatment satisfaction and health-related quality of life (HRQoL) aspects during long-term real-life psoriasis management.

Methods: PRO-long was a multicentre, prospective, observational, 52-week study of patients prescribed fixed combination Cal/BD gel or ointment in clinical practice. For final analysis the following were assessed at weeks 24, 36 and 52: differences in the proportion of patients with 'mild'/'very mild' disease according to patient's global assessment of disease severity, adherence behaviour, treatment satisfaction (nine-item treatment satisfaction questionnaire for medication) and HRQoL (Skindex-29).

Results: Patients (n = 328) were prescribed once-daily Cal/BD gel (n = 152) or ointment (n = 176). At week 52, a higher proportion of patients reported that the severity of their psoriasis was 'mild'/'very mild' vs. baseline (gel: 60.2 vs. 47.1%; ointment: 58.8 vs. 42.4%), with greater treatment satisfaction reported in patients using gel vs. those using ointment. A higher proportion of patients found the gel 'easy' to use compared with the ointment (66.7 vs. 45.2%). Daily application of treatment took ≤ 5 min for 86.1% of patients using gel and 71.0% of patients using ointment.

Conclusion: This real-life study has demonstrated similar effectiveness between the Cal/BD formulations. However, over a 52-week treatment period, patients reported greater treatment satisfaction with the gel, which was considered easier to use, faster to apply and overall a more convenient product.

Publication types

  • Comparative Study
  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-Inflammatory Agents / administration & dosage*
  • Betamethasone / administration & dosage
  • Betamethasone / analogs & derivatives*
  • Calcitriol / administration & dosage
  • Calcitriol / analogs & derivatives*
  • Child
  • Dermatologic Agents / administration & dosage*
  • Drug Combinations
  • Female
  • Gels
  • Humans
  • Male
  • Medication Adherence
  • Middle Aged
  • Ointments
  • Patient Satisfaction
  • Prospective Studies
  • Psoriasis / drug therapy*
  • Quality of Life
  • Severity of Illness Index
  • Time Factors
  • Young Adult

Substances

  • Anti-Inflammatory Agents
  • Dermatologic Agents
  • Drug Combinations
  • Gels
  • Ointments
  • calcipotriene
  • betamethasone-17,21-dipropionate
  • Betamethasone
  • Calcitriol