贝利单抗和telitacicept治疗系统性红斑狼疮患者的疗效和安全性评价:一项回顾性观察性研究的结果。

IF 3.2 4区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Tianxiao Feng, Manyu Zhang, Jieying Wang, Yang Li, Yang Cui
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引用次数: 0

摘要

本研究旨在评估贝利姆单抗和telitacicept治疗活动性系统性红斑狼疮(SLE)的有效性和安全性,并探索治疗-靶标模式下的潜在预测因素。101例患者于2021年1月至2023年12月在广东省人民医院回顾性入选,接受贝利单抗(n = 50)或telitacicept (n = 51)联合标准治疗超过24周。主要临床终点以狼疮低疾病活动状态(LLDAS)为主要终点进行评估。采用多变量分析来调查未能达到LLDAS的相关因素。在基于倾向评分的治疗加权逆概率后,两组的基线特征得到平衡。在24周时,telitacicept组的LLDAS达到率为54.86%,而belimumab组为33.13% (p = 0.048)。接受telitacicept的患者中,更大比例的患者的强的松剂量≤7.5 mg/天(p = 0.012)。在接受telitacicept治疗的患者中,补体C4水平的改善和严重低γ球蛋白血症的发生更为明显,在SLE应答指数4、DORIS缓解和肾脏反应方面没有差异。泰利他塞普治疗(OR = 0.80, p = 0.032)和补体C3水平升高(OR = 0.63, p = 0.003)与无法达到LLDAS的风险降低相关。两组均未发生严重不良事件。贝利单抗和telitacicept均显示出令人满意的有效性和安全性。我们的研究结果表明,telitacicept可能提供与早期达到LLDAS和减少糖皮质激素暴露相关的潜在益处。受观察性设计的限制,研究结果需要在前瞻性研究中进一步验证。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of the efficacy and safety of belimumab and telitacicept in patients with systemic lupus erythematosus: results from a retrospective, observational study.

This investigation aimed to evaluate the efficacy and safety of belimumab and telitacicept in active systemic lupus erythematosus (SLE) and to explore potential predictors within a treat-to-target paradigm. 101 individuals were retrospectively enrolled at Guangdong Provincial People's Hospital between January 2021 and December 2023, receiving either belimumab (n = 50) or telitacicept (n = 51) in conjunction with standard therapy for more than 24 weeks. Key clinical endpoints were evaluated, with lupus low disease activity state (LLDAS) as the primary outcome. Multivariate analysis was employed to investigate factors associated with failure to attain LLDAS. Baseline characteristics were balanced in both groups after propensity score-based inverse probability of treatment weighting. At 24 weeks, the rates of attainment of LLDAS were 54.86% in the telitacicept group and 33.13% in patients receiving belimumab (p = 0.048). A larger proportion of patients receiving telitacicept attained prednisone dosages of ≤ 7.5 mg/day (p = 0.012). Improvements in complement C4 levels and the occurrence of severe hypogammaglobulinemia were more pronounced among patients receiving telitacicept, with no differences in SLE Responder Index 4, DORIS remission, and renal response. Treatment with telitacicept (OR = 0.80, p = 0.032) and elevated levels of complement C3 (OR = 0.63, p = 0.003) were associated with a decreased risk of failing to achieve LLDAS. No severe adverse events were documented in both groups. Both belimumab and telitacicept displayed satisfactory effectiveness and safety profiles. Our findings imply telitacicept may offer potential benefits associated with the early attainment of LLDAS and reduced glucocorticoid exposure. Restricted by the observational design, the findings require further validation in prospective studies.

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来源期刊
Clinical and Experimental Medicine
Clinical and Experimental Medicine 医学-医学:研究与实验
CiteScore
4.80
自引率
2.20%
发文量
159
审稿时长
2.5 months
期刊介绍: Clinical and Experimental Medicine (CEM) is a multidisciplinary journal that aims to be a forum of scientific excellence and information exchange in relation to the basic and clinical features of the following fields: hematology, onco-hematology, oncology, virology, immunology, and rheumatology. The journal publishes reviews and editorials, experimental and preclinical studies, translational research, prospectively designed clinical trials, and epidemiological studies. Papers containing new clinical or experimental data that are likely to contribute to changes in clinical practice or the way in which a disease is thought about will be given priority due to their immediate importance. Case reports will be accepted on an exceptional basis only, and their submission is discouraged. The major criteria for publication are clarity, scientific soundness, and advances in knowledge. In compliance with the overwhelmingly prevailing request by the international scientific community, and with respect for eco-compatibility issues, CEM is now published exclusively online.
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