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泰它西普治疗系统性红斑狼疮的疗效与安全性:一项回顾性真实世界研究。

Efficacy and safety of telitacicept in the treatment of systemic lupus erythematosus: A retrospective real-world study.

作者信息

Zhang Jing, Sun Yue, Zhang Na, Chang Li-Hua, Jin Lei, Guo Yun

机构信息

Department of Rheumatology and Immunology, Shengjing Hospital of China Medical University, Shenyang, China.

出版信息

Lupus. 2025 May;34(6):597-607. doi: 10.1177/09612033251332052. Epub 2025 Apr 20.

Abstract

ObjectivesTo assess the real-world efficacy and safety of telitacicept in Chinese systemic lupus erythematosus (SLE) patients.MethodsThis retrospective single-center observational study enrolled 41 SLE patients treated with telitacicept between April 2021 and March 2022. Baseline characteristics and 24-week follow-up clinical outcomes were collected for analysis.ResultsA total of 41 SLE patients who received telitacicept at least once were included. Compared with baseline (10.0 ± 6.85), SLEDAI-2K scores significantly decreased at 12 weeks (6.25 ± 5.46, < .001) and 24 weeks (4.18 ± 4.78, < .001). The proportion of organ involvement, as assessed by SLEDAI-2K, significantly decreased in skin/mucosa and musculoskeletal involvement. The mean glucocorticoid dose (prednisone equivalent) was significantly reduced at 12 weeks (14.19 ± 8.88 mg/d, < .001) and 24 weeks (9.86 ± 4.25 mg/d, = .001) compared with baseline (20.87 ± 16.71 mg/d). C3 and C4 levels showed an increasing trend. In patients with lupus nephritis, 24-h urinary protein levels significantly reduced from 2.81 ± 3.83 g/day at baseline to 1.00 ± 1.32 g/day after 24 weeks of treatment ( = .005), with a 68.66% decline (IQR, 35.61%, 76.30%). Albumin levels also significantly improved ( = .003). Nine treatment-emergent adverse events (TEAEs) were recorded in six patients, all of which were mild and moderate.ConclusionsIn this real-world study, telitacicept combined with conventional therapy showed good onset efficacy and safety for treating SLE patients.

摘要

目的

评估泰它西普在中国系统性红斑狼疮(SLE)患者中的真实世界疗效和安全性。

方法

这项回顾性单中心观察性研究纳入了2021年4月至2022年3月期间接受泰它西普治疗的41例SLE患者。收集基线特征和24周随访临床结局进行分析。

结果

共纳入41例至少接受过一次泰它西普治疗的SLE患者。与基线时(10.0±6.85)相比,SLEDAI-2K评分在12周时(6.25±5.46,P<0.001)和24周时(4.18±4.78,P<0.001)显著降低。根据SLEDAI-2K评估,皮肤/黏膜和肌肉骨骼受累方面的器官受累比例显著降低。与基线时(20.87±16.71mg/d)相比,12周时(14.19±8.88mg/d,P<0.001)和24周时(9.86±4.25mg/d,P=0.001)平均糖皮质激素剂量(泼尼松等效剂量)显著降低。C3和C4水平呈上升趋势。在狼疮性肾炎患者中,24小时尿蛋白水平从基线时的2.81±3.83g/天显著降低至治疗24周后的1.00±1.32g/天(P=0.005),下降了68.66%(四分位距,35.61%,76.30%)。白蛋白水平也显著改善(P=0.003)。6例患者记录到9起治疗中出现的不良事件(TEAE),均为轻度和中度。

结论

在这项真实世界研究中,泰它西普联合传统疗法治疗SLE患者显示出良好的起效疗效和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/96dc/12010050/40bb36eb9974/10.1177_09612033251332052-fig1.jpg

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