Calcipotriol/betamethasone aerosol foam (Enstilum) for the topical treatment of psoriasis vulgaris in routine practice in Korea: A prospective, noninterventional, multicenter study of treatment outcomes and patient satisfaction

Seong Jin Jo, Chul Jong Park, Chul Hwan Bang, Ki Heon Jeong, Bong Seok Shin, Dong Hyun Kim, Hai Jin Park, Byung Soo Kim, Hae Jun Song, Ju Hee Lee, Sang Woong Youn

Research output: Contribution to journalArticlepeer-review

Abstract

An innovative foam formulation for the fixed-dose combination of calcipotriol and betamethasone dipropionate (Cal/BD) has recently become available for the treatment of psoriasis vulgaris. Observational studies of patients treated with Cal/BD foam in routine practice have been conducted in several Western countries, but there are limited data on outcomes in Asian patients. We performed a prospective, open-label, noncomparative, noninterventional study to investigate treatment outcomes and satisfaction in adult patients receiving Cal/BD foam for psoriasis vulgaris in dermatological centers and outpatient clinics in Korea. Data were collected at the time of enrollment (Visit 1) and at a routine clinic visit ~4 weeks later (Visit 2). In total, 218 patients were enrolled, of whom 175 were included in the safety analysis set (58.9% male; mean age ± standard deviation 46.7 ± 15.1 years; use of Cal/BD foam at least once daily 74.3%). Of the safety analysis set, 166 patients had at least mild psoriasis (Investigator Global Assessment [IGA] ≥ 2) and were analyzed for treatment outcomes and satisfaction. Of the 166 patients, 71.7% had mild psoriasis (IGA 2) at baseline. The majority (57.8%) achieved an IGA of 0/1 (clear/almost clear) at Visit 2. The Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) showed significant improvements from Visit 1 to Visit 2 (PASI −2.4 ± 3.0, DLQI −4.5 ± 5.2, both P < 0.0001). Most of the patients were satisfied with the Cal/BD foam treatment; 77.0%, 60.0%, and 73.9% were satisfied in terms of effectiveness, ease of use, and global satisfaction, respectively. In the safety analysis set, adverse events were reported in 13 patients (7.4%). In conclusion, this first Korean real-world study of Cal/BD foam shows improvement of lesions and health-related quality of life after 4 weeks of treatment, with high global satisfaction and good overall tolerability and safety.

Original languageEnglish
Pages (from-to)1085-1095
Number of pages11
JournalJournal of Dermatology
Volume49
Issue number11
DOIs
StatePublished - Nov 2022

Keywords

  • Korea
  • betamethasone dipropionate
  • calcipotriol drug combination
  • health-related quality of life
  • observational study
  • psoriasis

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