a Department of Dermatology , Kurume University School of Medicine , Fukuoka , Japan.
J Dermatolog Treat. 2019 Jun;30(4):383-386. doi: 10.1080/09546634.2018.1525480. Epub 2018 Oct 8.
Real-world data differ from clinical trial data. Although some real-world data regarding apremilast use for psoriasis treatment has been reported in Western countries, no such data has been reported in Asian countries. To study the efficacy, including Psoriasis Area and Severity Index (PASI) and drug survival, and safety of apremilast in Japanese patients with psoriasis. Data on all the patients treated with apremilast in Kurume University Hospital between May 2017 and June 2018 were retrieved, with June 30 2018, as the data lock date. Efficacy was analyzed by PASI50, PASI75, and PASI90; drug survival by Kaplan-Meier analysis; and drug safety by the proportion of adverse events (AEs). Fourteen of 42 (33.3%) patients achieved PASI75/90; 16 (32%) patients had discontinued apremilast by the data lock date. Drug survival at week 28 was 70%. No serious AEs were reported; the most prevalent one was loose stools/diarrhea (60%), followed by nausea (38%). The most common reason for apremilast discontinuation was primary/secondary failure. Apremilast is safe and effective in Japanese patients with psoriasis. Higher occurrence of loose stools/diarrhea was noted in our cohort than that reported in Western real-world studies on apremilast.
真实世界数据与临床试验数据不同。虽然在西方国家已经报道了一些关于阿普米司特治疗银屑病的真实世界数据，但在亚洲国家尚未有相关报道。本研究旨在评估阿普米司特治疗日本银屑病患者的疗效（包括银屑病面积和严重程度指数（PASI）和药物生存情况）和安全性。检索了 2017 年 5 月至 2018 年 6 月在久留米大学医院接受阿普米司特治疗的所有患者的数据，数据锁定日期为 2018 年 6 月 30 日。通过 PASI50、PASI75 和 PASI90 分析疗效；通过 Kaplan-Meier 分析评估药物生存情况；通过不良反应（AE）比例评估药物安全性。42 例患者中有 14 例（33.3%）达到 PASI75/90；16 例（32%）患者在数据锁定日期前已停止使用阿普米司特。第 28 周的药物生存率为 70%。未报告严重 AE；最常见的 AE 为稀便/腹泻（60%），其次为恶心（38%）。阿普米司特停药的最常见原因是原发性/继发性失败。阿普米司特在日本银屑病患者中安全且有效。与西方阿普米司特真实世界研究相比，本研究队列中稀便/腹泻的发生率更高。
