Department of Dermatology, Teikyo University School of Medicine, Tokyo, Japan.
Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
J Dermatol. 2023 Nov;50(11):1415-1426. doi: 10.1111/1346-8138.16926. Epub 2023 Aug 24.
Psoriasis is a chronic, immune-mediated inflammatory skin disease with a high negative impact on patient's quality of life. Secukinumab, the first interleukin 17A inhibitor, has been used for the systemic treatment of psoriasis, but its long-term, real-world retention rates in Japan have not been fully investigated. In this multicenter, noninterventional, retrospective chart review study, the retention rate of secukinumab and its effectiveness among patients with psoriasis in Japan was evaluated up to 5 years. Data of patients who received secukinumab after December 26, 2014, were collected from medical charts obtained from seven sites, all certified for biologics use by the Japanese Dermatological Association. Patient characteristics, secukinumab retention, factors affecting secukinumab retention, reason for drug discontinuation, and effectiveness data were collected. The primary end point was secukinumab retention rate at week 52. A total of 123 patients were included in the analysis. Of these, 27 patients discontinued secukinumab by week 52, yielding a 78.0% (95% confidence interval, 69.6-84.4) retention rate at week 52. For patients whose Psoriasis Area and Severity Index (PASI) score was available, mean ± standard deviation PASI at baseline and at week 52 were 9.21 ± 7.37 and 1.4 ± 2.6, respectively. During the entire study period, "insufficient response" was the most common reason for discontinuation, and "history of biologics use" was a factor significantly associated with secukinumab discontinuation (hazard ratio, 1.72; p = 0.018). This study demonstrates the real-world retention rate and effectiveness of secukinumab in patients with psoriasis in Japan for up to 5 years and provides clinical insights into psoriasis treatment strategies.
银屑病是一种慢性、免疫介导的炎症性皮肤病，对患者的生活质量有很大的负面影响。司库奇尤单抗是首个白细胞介素 17A 抑制剂，已被用于银屑病的系统治疗，但在日本，其长期的真实世界保留率尚未得到充分研究。在这项多中心、非干预性、回顾性病历审查研究中，评估了司库奇尤单抗在日本银屑病患者中的保留率及其疗效，最长可达 5 年。从日本皮肤科协会认证的 7 个地点获得的病历中收集了 2014 年 12 月 26 日后接受司库奇尤单抗治疗的患者的数据。收集了患者特征、司库奇尤单抗保留率、影响司库奇尤单抗保留率的因素、停药原因和疗效数据。主要终点是第 52 周时司库奇尤单抗的保留率。共有 123 名患者纳入分析。其中，27 名患者在第 52 周时停用司库奇尤单抗，第 52 周时的保留率为 78.0%（95%置信区间，69.6-84.4）。对于可获得银屑病面积和严重程度指数（PASI）评分的患者，基线和第 52 周时的平均±标准差 PASI 分别为 9.21±7.37 和 1.4±2.6。在整个研究期间，“应答不足”是停药的最常见原因，“生物制剂使用史”是与司库奇尤单抗停药显著相关的因素（风险比，1.72；p=0.018）。这项研究表明，在日本，司库奇尤单抗在银屑病患者中的真实世界保留率和疗效最长可达 5 年，并为银屑病治疗策略提供了临床见解。
