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. Issue 11 (18th July 2022)

• Record Type: Journal Article
• Authors: Jo, Seong Jin; Park, Chul‐Jong; Bang, Chul Hwan; Jeong, Ki‐Heon; Shin, Bong Seok; Kim, Dong Hyun; Park, Hai‐Jin; Kim, Byung‐Soo; Song, Hae‐Jun; Lee, Ju‐Hee; Youn, Sang Woong
• Is Part Of: Journal of dermatology. Volume 49:Issue 11(2022)
• Page Start: 1085
• Page End: 1095
• Publication Date: 2022-07-18
• Subjects: betamethasone dipropionate -- calcipotriol drug combination -- health‐related quality of life -- Korea -- observational study -- psoriasis; Dermatology -- Periodicals; Dermatology -- Japan -- Periodicals; Skin -- Diseases -- Periodicals; 616.5005
• DOI: 10.1111/1346-8138.16519
• Languages: English
• ISSNs: 0385-2407

Abstract

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.