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

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 significantThis is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Improvements in Plaque Psoriasis Associated with Calcipotriol/Betamethasone Aerosol Foam Treatment: A Post Hoc Analysis of Non-interventional Studies and Clinical Experience

“…This post hoc analysis consolidated shared baseline characteristics and effectiveness data from NIS of Cal/BD foam from five European countries and from Korea. Overall, consistent improvement in signs and symptoms of psoriasis was observed in patients on 4 weeks of Cal/BD foam treatment, with alignment between the randomized clinical trials (RCTs) and the RWE included here [ 12 – 17 ]. There are differences, however, that are important to consider between the countries and their respective studies that may provide insight and context on how the different patient populations may benefit from this topical therapy.…”

“…Difficulties from the COVID-19 pandemic also contributed to the poorer recruitment and smaller size of the final analysis set (i.e., number of patients with before and after treatment assessments) in the French NIS [ 16 ]. In contrast, the Italian ( n ≥ 200) and Korean ( n = 218) NIS enrolled their planned number of patients, so dropouts due to the COVID-19 pandemic only decreased the size of their final analysis sets and were not expected to impact the overall results of the studies [ 15 , 17 ]. Further, it is difficult to schedule an appointment with a dermatologist in France, with wait times of up to 1 year.…”

“…Of the seven remaining prospective studies with data on 4 weeks of Cal/BD foam treatment, one was omitted, as it focused on scalp psoriasis [ 19 ], and the endpoints are not comparable to the other six studies. The post hoc analysis reported here included six total phase 4 NIS (five from European countries, one from Asia) of 4 weeks of Cal/BD foam treatment in patients with plaque psoriasis (Table 1 ): Germany (NIS-1295, completed 03/2017) [ 12 ]; Greece (NIS-1438, completed 02/2019) [ 13 ]; Austria (NIS-1363, completed 03/2020) [ 14 ]; Italy (NIS-1473, completed 11/2020) [ 15 ]; France (NIS-1447, completed 11/2020) [ 16 ]; and Korea (NIS-1524, completed 07/2021) [ 17 ]. Since the six Cal/BD foam studies are NIS, the inclusion and exclusion criteria were per label in each country.…”

“…1 Selection of Cal/BD foam NIS for a post hoc analysis of effectiveness outcomes. a Gerdes et al [ 12 ]; b Rigopoulos et al [ 13 ]; c Zenahlik et al [ 14 ]; d Campanati et al [ 15 ]; e Misery et al [ 16 ]; f Jo et al [ 17 ]. g Staubach et al [ 19 ].…”

Basic Therapeutic Approach for Patients with Plaque Psoriasis: Korean Expert Consensus Using the Modified Delphi Method

“…In Korea, various topical and systemic agents are used to treat psoriasis. Various topical corticosteroids, calcineurin inhibitors, and combinations of corticosteroids and vitamin D analogs are readily available 6 . Phototherapy using narrow-band ultraviolet B radiation is widely used in both private dermatologic clinics and hospitals.…”