Department of Dermatology and Allergy, University Medical Center, Mainz, Germany.
LEO Pharma GmbH, Neu-Isenburg, Germany.
Dermatology. 2023;239(2):206-216. doi: 10.1159/000527496. Epub 2023 Jan 30.
Clinical trials have demonstrated the efficacy of fixed-dose combination calcipotriol/betamethasone (Cal/BD) aerosol foam for the treatment of patients with scalp psoriasis. However, data on the real-world effectiveness of Cal/BD aerosol foam in this subgroup of patients are lacking. Therefore, this study investigated the effectiveness and tolerability of 4 weeks' treatment with Cal/BD aerosol foam in patients with scalp psoriasis in everyday clinical practice.
This prospective, non-interventional multicenter study involved 217 adults with scalp psoriasis who were treated with Cal/BD aerosol foam for 4 weeks. Primary endpoints included the proportion of patients with <10% of the scalp area affected (Scalp-BSA) plus a Scalp-PGA of "mild" after 4 weeks, as well as the proportion of patients with an absolute PSSI ≤2 points after 4 weeks. Secondary endpoints included patient reported changes in erythema, itching, flaking, and thickness at baseline, 3 days, 1 week, 2 weeks, and 4 weeks.
After 4 weeks, 53.4% of patients treated with Cal/BD aerosol foam had achieved a Scalp-BSA of <10% and a mild Scalp-PGA. Furthermore, 47.6% of patients achieved a PSSI ≤2. Improvements in pruritus and other symptoms (induration, erythema, and scaling) were seen already within 3 days. The proportion of patients who reported that scalp psoriasis had no influence on their quality of life (Dermatology Quality of Life Index 0/1 points) increased from 3.2% at baseline to 47.9% at study end. Patient satisfaction with treatment was high (Treatment Satisfaction Questionnaire-9 scores of 74.5 ± 27.1 for effectiveness, 72.0 ± 25.2 for ease of use, and 77.8 ± 24.2 for general satisfaction). Overall, 97.4% of HCPs assessed the tolerability of Cal/BD aerosol foam as good/very good with no new safety concerns.
This study demonstrated the effectiveness, rapid onset of action, good tolerability, and good safety profile of the Cal/BD aerosol foam in patients with scalp psoriasis treated in a real-world setting.
临床试验已经证明了固定剂量复方钙泊三醇/倍他米松（Cal/BD）气雾剂泡沫在治疗头皮银屑病患者方面的疗效。然而，缺乏关于 Cal/BD 气雾剂泡沫在这一亚组患者中的实际有效性的数据。因此，本研究调查了 Cal/BD 气雾剂泡沫在日常临床实践中治疗头皮银屑病患者 4 周的有效性和耐受性。
这是一项前瞻性、非干预性多中心研究，涉及 217 名患有头皮银屑病的成年人，他们接受 Cal/BD 气雾剂泡沫治疗 4 周。主要终点包括治疗 4 周后头皮面积受累程度<10%（头皮-BSA）加上头皮 PGA 为“轻度”的患者比例，以及治疗 4 周后绝对 PSSI≤2 分的患者比例。次要终点包括治疗前、治疗后 3 天、1 周、2 周和 4 周时患者报告的红斑、瘙痒、脱屑和厚度的变化。
治疗 4 周后，53.4%接受 Cal/BD 气雾剂泡沫治疗的患者头皮-BSA<10%，头皮 PGA 为轻度。此外，47.6%的患者 PSSI≤2。瘙痒和其他症状（硬结、红斑和鳞屑）的改善在 3 天内就已经出现。报告头皮银屑病对生活质量没有影响（皮肤病生活质量指数 0/1 分）的患者比例从基线时的 3.2%增加到研究结束时的 47.9%。患者对治疗的满意度很高（治疗满意度问卷-9 评分，对疗效的评分为 74.5±27.1，对易用性的评分为 72.0±25.2，对总体满意度的评分为 77.8±24.2）。总体而言，97.4%的 HCP 评估 Cal/BD 气雾剂泡沫的耐受性良好/非常好，没有新的安全性问题。
本研究表明，Cal/BD 气雾剂泡沫在现实环境中治疗头皮银屑病患者时具有疗效、起效迅速、良好的耐受性和良好的安全性。
