Department of Rheumatology, Zhangzhou Affiliated Hospital of Fujian Medical University, No.59 Shengli West Road, Xiangcheng District, Zhangzhou, 363000, Fujian Province, China.
Clin Exp Nephrol. 2024 Sep;28(9):902-909. doi: 10.1007/s10157-024-02501-x. Epub 2024 Apr 13.
Telitacicept, an innovative drug used for the treatment of systemic lupus erythematosus (SLE), can effectively control disease progression and achieve favorable outcomes. While case reports have mentioned the use of Telitacicept in lupus nephritis (LN) treatment, its safety and efficacy in treating patients with LN have not been explored. Therefore, in this study, we aimed to evaluate the safety and efficacy of Telitacicept in managing patients with LN.
In a single-center, real-world retrospective study, 30 LN patients with poor response or adverse reactions to conventional glucocorticoids at our Hospital were enrolled to receive Telitacicept. Patients were administered 160 mg of Telitacicept subcutaneously once a week for at least 24 weeks in addition to standard treatment. We assessed the SLE responder index-4 (SRI-4) at the beginning and the end of the treatment period, measured laboratory test indicators at 3, 6, and 9 months, and observed the occurrence of adverse events in these patients.
The SRI-4 response rate was 86.67% (n = 26), with a significantly lower systemic lupus erythematosus disease activity index (SLEDAI) score compared to the baseline. Post Telitacicept treatment, glucocorticoid intake of patients with LN significantly reduced from 50 (IQR:40, 51.25) at baseline to 10 (IQR:5,10) at the endpoint (Z = - 6.547, p < 0.001). Patients with LN showed significantly improved urine occult blood levels after Telitacicept therapy. While the complement (C3 and C4) contents increased, immunoglobulins (IgG, IgA and IgM) reduced markedly (p < 0.001). The negative rate of dsDNA reached 26.67% and adverse events were alleviated post treatment. Only two cases of LN-related adverse reactions were reported, including herpes and infectious fever, respectively. Telitacicept primarily serves as an agent for the induction of remission therapy, with an attainment of complete remission rate standing at a commendable 73.3%.
Telitacicept treatment reduced disease severity in patients with LN. The initial clinical trial provided supportive evidence for the effectiveness and safety of Telitacicept as a viable treatment option for LN, allowing a reduction in the daily glucocorticoid intake while maintaining a good safety profile, and improving hypocomplementation in LN management.
替利昔塞普特是一种用于治疗系统性红斑狼疮（SLE）的创新药物，可有效控制疾病进展并取得良好疗效。虽然病例报告提到了替利昔塞普特在狼疮性肾炎（LN）治疗中的应用，但尚未探讨其在 LN 患者中的安全性和疗效。因此，本研究旨在评估替利昔塞普特治疗 LN 患者的安全性和疗效。
在我院进行的一项单中心、真实世界回顾性研究中，纳入了 30 例对常规糖皮质激素反应不佳或有不良反应的 LN 患者，给予替利昔塞普特治疗。患者每周皮下注射 160mg 替利昔塞普特，同时接受标准治疗，至少 24 周。我们在治疗前后评估 SLE 应答指数-4（SRI-4），在 3、6 和 9 个月时测量实验室检测指标，并观察这些患者不良事件的发生情况。
SRI-4 应答率为 86.67%（n=26），与基线相比，系统性红斑狼疮疾病活动指数（SLEDAI）评分显著降低。替利昔塞普特治疗后，LN 患者的糖皮质激素摄入量从基线时的 50（IQR：40，51.25）显著减少到终点时的 10（IQR：5，10）（Z=-6.547，p<0.001）。LN 患者在替利昔塞普特治疗后尿潜血水平明显改善。同时，补体（C3 和 C4）含量升高，免疫球蛋白（IgG、IgA 和 IgM）显著降低（p<0.001）。dsDNA 的阴性率达到 26.67%，治疗后不良反应减轻。仅报告了 2 例与 LN 相关的不良反应，分别为疱疹和传染性发热。替利昔塞普特主要作为诱导缓解治疗的药物，完全缓解率达到了令人赞赏的 73.3%。
替利昔塞普特治疗降低了 LN 患者的疾病严重程度。初步临床试验为替利昔塞普特作为 LN 治疗的有效和安全选择提供了支持证据，在维持良好安全性的同时，减少了每日糖皮质激素的摄入，并改善了 LN 管理中的低补体血症。
