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治疗活跃狼性炎的secukinumab:来自第三阶段,随机化,安慰剂对照研究 (SELUNE) 和开放式扩展研究的结果

Ming-Hui Zhao¹, Fidencio Cons Molina², Gustavo Aroca³

¹Renal Division, Peking University First Hospital, Peking University Institute of Nephrology, Beijing, China.

Rheumatology (Oxford, England)

|October 15, 2025

概括

与安慰剂相比,secukinumab在狼性炎 (LN) 患者的疗效没有得到改善. 治疗耐受性良好,在此临床试验中没有发现新的安全问题.

科学领域:

腎臟病學 (nephrology) 是一種醫學專業.
类风湿病学类风湿病学
免疫学免疫学免疫学

背景情况:

狼性炎 (LN) 是系统性红斑狼的严重并发症,通常导致功能衰竭.
活跃LN的标准护理 (SoC) 有局限性,需要新的治疗方法.
塞库金努马布 (Secukinumab) 是一种联素-17A抑制剂,研究其在治疗活性LN的潜力.

研究的目的:

评估300毫克加SoC和安慰剂加SoC在成年患有活跃LN的患者体内皮下sequinumab300毫克加SoC的疗效和安全性.
为了确定secukinumab是否改善活跃狼性炎的反应率.
评估secukinumab在该患者群体中的安全性.

主要方法:

进行了第三期随机,安慰剂控制,双盲研究 (NCT04181762).
患者接受了300毫克或安慰剂Secukinumab 4 周,随后每月维持剂量,以及SoC.
主要终点是患者在52周内达到完全功能响应 (CRR) 的比例.

主要成果:

该研究因徒劳性分析表明塞库金纽马布对安慰剂没有显著益处而提前终止.
在52周后的CRR率在sequinumab组 (24.2%) 与安慰剂组 (36.3%) 相比较较低.
治疗出现的不良事件在两组之间是可比的;没有观察到新的安全信号.

结论:

与安慰剂相比,secukinumab在患有活跃狼性炎的患者中没有显示出更高的疗效.
发现secukinumab在受研究的人群中耐受性很好.
对治疗狼性炎的secukinumab进行进一步的研究没有得到这些发现的支持.

关键词:

生物疗法是生物疗法.临床试验和方法.干预性研究是干预性研究.腎的腎的腎的腎的系统性红斑狼和自身免疫

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