Department of Dermatology, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea.
Department of Dermatology, Bucheon St. Mary's Hospital, The Catholic University of Korea, Bucheon, South Korea.
J Dermatol. 2022 Nov;49(11):1085-1095. doi: 10.1111/1346-8138.16519. Epub 2022 Jul 18.
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.
一种新型的钙泊三醇倍他米松二丙酸酯（Cal/BD）固定剂量复方泡沫制剂已可用于治疗寻常型银屑病。在几个西方国家，已经开展了多项在常规实践中接受 Cal/BD 泡沫治疗的患者观察性研究，但亚洲患者的结局数据有限。我们进行了一项前瞻性、开放标签、非对照、非干预性研究，以调查在韩国皮肤科中心和门诊接受 Cal/BD 泡沫治疗寻常型银屑病的成年患者的治疗结局和满意度。数据在入组时（访视 1）和大约 4 周后的常规就诊时（访视 2）收集。共有 218 名患者入组，其中 175 名患者纳入安全性分析集（58.9%为男性；平均年龄 ± 标准差 46.7±15.1 岁；至少每日使用 Cal/BD 泡沫 1 次 74.3%）。安全性分析集中，166 名患者至少患有轻度银屑病（研究者整体评估 [IGA]≥2），对其进行治疗结局和满意度分析。166 名患者中，71.7%基线时患有轻度银屑病（IGA 2）。大多数（57.8%）患者在访视 2 时达到 IGA 0/1（清除/几乎清除）。银屑病面积严重程度指数（PASI）和皮肤病生活质量指数（DLQI）显示从访视 1 到访视 2 显著改善（PASI-2.4±3.0，DLQI-4.5±5.2，均 P<0.0001）。大多数患者对 Cal/BD 泡沫治疗满意；分别有 77.0%、60.0%和 73.9%的患者对有效性、易用性和总体满意度表示满意。安全性分析集中，13 名患者（7.4%）报告了不良事件。总之，这项 Cal/BD 泡沫在韩国的首个真实世界研究显示，在治疗 4 周后皮损和健康相关生活质量得到改善，总体满意度高，且整体耐受性和安全性良好。
