Sotiriou Elena, Tsentemeidou Aikaterini, Sideris Nikolaos, Lallas Aimilios, Kougkas Nikolaos, Ioannides Dimitrios, Vakirlis Efstratios
First Department of Dermatology and Venereology, School of Medicine, Aristotle University, Thessaloniki, Greece.
Fourth Department of Internal Medicine, Aristotle University of Thessaloniki, Greece.
Dermatol Pract Concept. 2022 Jan 1;12(2):e2022076. doi: 10.5826/dpc.1202a76. eCollection 2022 May.
Drug survival is an indirect measure of efficacy and safety and its post-marketing assessment using real-life data is invaluable.
To investigate the survival of apremilast in a cohort of psoriasis patients treated with apremilast in a Greek hospital.
A retrospective cross-sectional study examined adult psoriasis patients receiving apremilast (March 2016 to January 2021). Primary endpoint was the cumulative survival probability at 52 weeks. Kaplan-Meier analysis was used to calculate survival probability. Cox regression analysis was performed to investigate potential risk factors for apremilast discontinuation.
One hundred and two patients (29.4% females) with a mean age of 55.9 years (standard deviation 15.21) were included. Sixty-five patients (63.7%) had discontinued treatment by lock date: 19 (18.6%) due to lack of efficacy, 24 (23.5%) due to loss of efficacy, 15 (14.7%) due to adverse reactions, and 7 (6.9%) due to other reasons. Cumulative survival probability at 52 weeks was 52.1%. Median survival time for all reasons for discontinuation was 58 weeks (95% Confidence Interval 40.02, 75.98).
Approximately half of patients remained on apremilast after 1 year of treatment. Secondary drug failure was the most common reason for discontinuation.
药物留存率是疗效和安全性的间接指标,利用真实世界数据进行上市后评估具有重要价值。
调查在希腊一家医院接受阿普米司特治疗的银屑病患者队列中阿普米司特的留存情况。
一项回顾性横断面研究对2016年3月至2021年1月期间接受阿普米司特治疗的成年银屑病患者进行了检查。主要终点是52周时的累积留存概率。采用Kaplan-Meier分析计算留存概率。进行Cox回归分析以研究阿普米司特停药的潜在风险因素。
纳入了102例患者(女性占29.4%),平均年龄55.9岁(标准差15.21)。截至锁定日期,65例患者(63.7%)已停药:19例(18.6%)因疗效不佳停药,24例(23.5%)因疗效丧失停药,15例(14.7%)因不良反应停药,7例(6.9%)因其他原因停药。52周时的累积留存概率为52.1%。所有停药原因的中位留存时间为58周(95%置信区间40.02,75.98)。
治疗1年后,约一半患者仍在使用阿普米司特。继发性药物失效是停药的最常见原因。