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贝利尤单抗和泰它西普治疗系统性红斑狼疮的有效性和安全性:一项真实世界、回顾性观察研究。

Effectiveness and safety of Belimumab and Telitacicept in systemic lupus erythematosus: a real-world, retrospective, observational study.

作者信息

Jin Hui-Zhi, Cai Ming-Long, Wang Xin, Li Zhijun, Ma Bin, Niu Lin, Wang Peng, Pan Hai-Feng, Li Si-Dong, Bao Wei, Wang Guo-Sheng, Li Xiao-Mei, Xie Changhao, Chen Zhu

机构信息

Department of Rheumatology and Immunology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Lujiang Str 17, Hefei, 230001, Anhui, China.

Department of Rheumatology and Immunology, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China.

出版信息

Clin Rheumatol. 2025 Jan;44(1):247-256. doi: 10.1007/s10067-024-07266-y. Epub 2024 Dec 16.

Abstract

OBJECTIVE

To examine the effectiveness and safety of two different B cell activating factor/proliferation-inducing ligand inhibitors, telitacicept and belimumab, in treating patients with active systemic lupus erythematosus (SLE).

METHODS

Patients with active SLE who received belimumab (n = 100) or telitacicept (n = 101) from 2019 to 2023 at multiple centers in China were retrospectively collected, and the effectiveness and safety of telitacicept and belimumab was evaluated. The subgroups of lupus nephritis and hematologic abnormalities were analyzed to explore if there were any differences in the efficacy of the two biologics on improving kidney and blood systems. Propensity score-based inverse probability of treatment weighting (IPTW) was used to reduce selection bias.

RESULTS

No significant between-group differences in patient characteristics were observed after adjustment by IPTW. The proportion of SLE Responder Index 4 at 24 weeks was significantly higher in the telitacicept group (p = 0.031), but no significant difference was observed in 52 weeks follow-up data. More significant improvements were observed in telitacicept group for C4 and a larger decrease was observed in telitacicept group for IgA and IgM levels at 4 weeks. A better improvement of hemoglobin in anemia patients from the telitacicept group at 24 weeks was observed. There were no significant differences in kidney effectiveness and treatment-related adverse events differences between the two groups.

CONCLUSIONS

Patients receiving telitacicept showed a higher SRI-4 rate compared to those receiving belimumab at 24 weeks. Due to the real-world nature of this study and the limitation of IPTW application, further extensive investigations in larger cohorts and head-to-head clinical trials are required to validate these findings. Key Points • The telitacicept group displayed a higher SRI-4 rate at 24 weeks and a more substantial improvement in serological indices at 4 weeks. • No differences were observed in the effectiveness in lupus nephritis patients between belimumab and telitacicept groups. • A better improvement of hemoglobin in anemia patients at 24 weeks was observed in telitacicept group.

摘要

目的

研究两种不同的B细胞活化因子/增殖诱导配体抑制剂——泰它西普和贝利尤单抗,治疗活动性系统性红斑狼疮(SLE)患者的有效性和安全性。

方法

回顾性收集2019年至2023年在中国多个中心接受贝利尤单抗(n = 100)或泰它西普(n = 101)治疗的活动性SLE患者,评估泰它西普和贝利尤单抗的有效性和安全性。分析狼疮性肾炎和血液学异常亚组,以探讨这两种生物制剂在改善肾脏和血液系统方面的疗效是否存在差异。采用基于倾向评分的逆概率加权法(IPTW)减少选择偏倚。

结果

IPTW调整后,两组患者特征无显著组间差异。泰它西普组在24周时SLE应答者指数4的比例显著更高(p = 0.031),但在52周的随访数据中未观察到显著差异。在4周时,泰它西普组C4改善更显著,IgA和IgM水平下降幅度更大。在24周时,观察到泰它西普组贫血患者的血红蛋白改善更好。两组在肾脏疗效和治疗相关不良事件方面无显著差异。

结论

在24周时,接受泰它西普治疗的患者SRI-4率高于接受贝利尤单抗治疗的患者。由于本研究的真实世界性质以及IPTW应用的局限性,需要在更大队列中进行进一步广泛研究和头对头临床试验来验证这些发现。要点 • 泰它西普组在24周时SRI-4率更高,在4周时血清学指标改善更显著。 • 贝利尤单抗组和泰它西普组在狼疮性肾炎患者的疗效方面未观察到差异。 • 在24周时,泰它西普组贫血患者的血红蛋白改善更好。

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