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司库奇尤单抗改善环孢素 A 应答不足的银屑病患者的症状:评估直接转换的前瞻性研究。

Secukinumab improves psoriasis symptoms in patients with inadequate response to cyclosporine A: A prospective study to evaluate direct switch.

机构信息

Jichi Medical University, Shimotsuke, Japan.

Nagoya City University, Nagoya, Japan.

出版信息

J Dermatol. 2017 Oct;44(10):1105-1111. doi: 10.1111/1346-8138.13911. Epub 2017 May 23.

Abstract

There are limited data on the safety and efficacy of switching to secukinumab from cyclosporine A (CyA) in patients with psoriasis. The purpose of the present study was to assess the efficacy and safety of secukinumab for 16 weeks after direct switching from CyA in patients with moderate-to-severe psoriasis. In this multicenter, open-label, phase IV study, 34 patients with moderate-to-severe psoriasis and inadequate response to CyA received secukinumab 300 mg s.c. at baseline and weeks 1, 2, 3, 4, 8 and 12. The primary end-point was ≥75% improvement from baseline in Psoriasis Area and Severity Index score (PASI 75) at week 16. The efficacy of secukinumab treatment was evaluated up to week 16, and adverse events (AE) were monitored during the study. The primary end-point of the PASI 75 response at week 16 was achieved by 82.4% (n = 28) of patients receiving secukinumab. Early improvements were observed with secukinumab, with PASI 50 response of 41.2% at week 2 and PASI 75 response of 44.1% at week 4. AE were observed in 70.6% (n = 24) of patients, and there were no serious AE or deaths reported in the entire study period. Secukinumab showed a favorable safety profile consistent with previous data with no new or unexpected safety signals. The results of the present study show that secukinumab is effective in patients with psoriasis enabling a smooth and safe direct switch from CyA to biological therapy.

摘要

关于将环孢素 A (CyA) 转换为司库奇尤单抗治疗银屑病患者的安全性和疗效的数据有限。本研究的目的是评估司库奇尤单抗在中重度银屑病患者从 CyA 直接转换后 16 周的疗效和安全性。在这项多中心、开放标签、IV 期研究中,34 名对 CyA 反应不足的中重度银屑病患者在基线时和第 1、2、3、4、8 和 12 周时接受司库奇尤单抗 300mg sc。主要终点是第 16 周时银屑病面积和严重程度指数评分(PASI 75)较基线改善≥75%。在第 16 周时,评估了司库奇尤单抗治疗的疗效,并在研究期间监测了不良反应(AE)。第 16 周时 PASI 75 应答的主要终点达到了 82.4%(n=28)接受司库奇尤单抗治疗的患者。司库奇尤单抗治疗早期就观察到改善,第 2 周 PASI 50 应答率为 41.2%,第 4 周 PASI 75 应答率为 44.1%。70.6%(n=24)的患者出现了 AE,整个研究期间没有严重 AE 或死亡报告。司库奇尤单抗的安全性特征与先前的数据一致,没有新的或意外的安全性信号。本研究结果表明,司库奇尤单抗对银屑病患者有效,能够安全平稳地从 CyA 直接转换为生物治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7fc5/5655923/37220498d70a/JDE-44-1105-g001.jpg

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