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泰它西普治疗系统性红斑狼疮的疗效与安全性:一项真实世界观察性研究。

The efficacy and safety of telitacicept for the treatment of systemic lupus erythematosus: a real life observational study.

作者信息

Chen Ruilin, Fu Rong, Lin Zeying, Huang Chenghui, Huang Wenhui

机构信息

Department of Rheumatology, The Second Affiliated Hospital, 220741Guangzhou Medical University, Guangzhou, Guangdong, China.

出版信息

Lupus. 2023 Jan;32(1):94-100. doi: 10.1177/09612033221141253. Epub 2022 Nov 23.

Abstract

OBJECTIVE

To investigate the efficacy and safety of telitacicept treatment in a Chinese SLE cohort, with real-life settings.

METHODS

All patients with SLE who were receiving telitacicept treatment at least 4 weeks were included, and were followed up. Patients received subcutaneous injection of telitacicept weekly based on the standard treatment. SLE responder index-4 (SRI-4) was assessed before the first administration and at least 4 weeks after the first administration. Disease flares during the follow-up period were defined as an increase in disease activity and the number or dose of immunosuppressive drugs.

RESULTS

After 4-45 weeks' administration of telitacicept, 80% ( = 16) reached SRI-4 response. The prednisolone dosage declined from a mean of 30.25 mg/d (95% CI 21.99-38.51) before treatment to 13.25 mg/d (95% CI 9.92-16.58) after treatment. The proportion of patients without receiving an immunosuppressive drug increased from 15% to 43% at the endpoint. 19 cases showed various reduction of IgM after treatment ( < 0.05) and C3 and C4 showed either stable or an upward trend. The 24 h urinary protein median value of the 14 cases (baseline 24 h urinary protein >0.5 g/d) showed significant reduction, and 7 of them turned negative. Adverse events were mild to moderate and controllable.

CONCLUSION

Telitacicept is a potential treatment option for patients with SLE, especially in lupus nephritis, with significantly increased SRI-4 response rate and reduced the glucocorticoid and immunosuppressive drugs.

摘要

目的

在真实临床环境下,研究泰它西普治疗中国系统性红斑狼疮(SLE)队列的疗效和安全性。

方法

纳入所有接受泰它西普治疗至少4周的SLE患者,并进行随访。患者在标准治疗基础上每周接受一次泰它西普皮下注射。在首次给药前和首次给药至少4周后评估SLE反应指数-4(SRI-4)。随访期间疾病复发定义为疾病活动度增加以及免疫抑制药物数量或剂量增加。

结果

在给予泰它西普4 - 45周后,80%(n = 16)达到SRI-4反应。泼尼松龙剂量从治疗前的平均30.25 mg/d(95%CI 21.99 - 38.51)降至治疗后的13.25 mg/d(95%CI 9.92 - 16.58)。在终点时,未接受免疫抑制药物的患者比例从15%增加到43%。19例患者治疗后IgM有不同程度下降(P < 0.05),C3和C4呈稳定或上升趋势。14例基线24小时尿蛋白>0.5 g/d患者的24小时尿蛋白中位数显著降低,其中7例转阴。不良事件为轻至中度且可控。

结论

泰它西普是SLE患者的一种潜在治疗选择,尤其是在狼疮性肾炎患者中,其SRI-4反应率显著提高,同时减少了糖皮质激素和免疫抑制药物的使用。

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