活动性系统性红斑狼疮中SRI-4与LLDAS达成的比较有效性及预测因素：泰它西普与贝利尤单抗的真实世界研究

摘要(中文译文)

比较泰它西普与贝利尤单抗在活动性系统性红斑狼疮（SLE）患者中达到系统性红斑狼疮应答指数4（SRI-4）和狼疮低疾病活动状态（LLDAS）的情况，并识别治疗应答的基线临床预测因素。这项回顾性观察性队列研究于2020年至2024年在中国单中心进行。共有115例活动性SLE患者在接受标准治疗的同时接受泰它西普（n = 60，每周80 mg或160 mg）或贝利尤单抗（n = 55，每4周10 mg/kg）治疗。主要结局为第24周时的SRI-4应答率。采用LASSO和多变量Cox比例风险模型识别基线预测因素。泰它西普在第4周时显示出显著更高的早期SRI-4应答率（16.7% [10/60] vs. 3.6% [2/55]；OR 5.30，95% CI 1.11-25.39，P = 0.037）。在第24周时，泰它西普的SRI-4应答率为56.7%（34/60），而贝利尤单抗为40.0%（22/55）（OR 1.96，95% CI 0.93-4.12，P = 0.075）。单变量Cox分析表明泰它西普的累积SRI-4发生率更优（HR 3.03，95% CI 1.30-7.08，P = 0.011）。多变量分析确认基线SLEDAI-2 K（HR 1.29，95% CI 1.17-1.42，P = 0.001）和血清白蛋白水平（HR 1.16，95% CI 1.08-1.24，P = 0.001）是SRI-4达成的独立预测因素。泰它西普组与贝利尤单抗组的总不良事件发生率相当（38.3% [23/60] vs. 34.6% [19/55]，P = 0.675）。在临床实践中，与贝利尤单抗相比，泰它西普与活动性SLE患者更早达成SRI-4相关。基线疾病活动度评分和血清白蛋白水平是预测治疗应答达成的关键预后标志物。要点 • 在真实世界环境中，与贝利尤单抗相比，泰它西普与活动性系统性红斑狼疮患者显著更快速地达成SRI-4应答相关。 • 基线SLEDAI-2 K评分和血清白蛋白水平被确定为达成早期治疗应答的独立预测因素。 • 这两种BAFF/APRIL抑制剂表现出不同的血液学影响：泰它西普显著改善血红蛋白水平，而贝利尤单抗在提高血小板计数方面更有效。 • 与标准剂量相比，更高剂量的泰它西普（160 mg）可能有助于更优地长期达成狼疮低疾病活动状态（LLDAS）。

Abstract

To compare the attainment of Systemic Lupus Erythematosus Responder Index 4 (SRI-4) and lupus low disease activity state (LLDAS) between telitacicept and belimumab in patients with active systemic lupus erythematosus (SLE), and to identify baseline clinical predictors of treatment response. This retrospective observational cohort study was conducted at a single center in China between 2020 and 2024. A total of 115 patients with active SLE received either telitacicept (n = 60, 80 mg or 160 mg weekly) or belimumab (n = 55, 10 mg/kg every 4 weeks) alongside standard therapy. The primary outcome was the SRI-4 response rate at week 24. Baseline predictors were identified using LASSO and multivariable Cox proportional hazards models. Telitacicept demonstrated a significantly higher early SRI-4 response at week 4 (16.7% [10/60] vs. 3.6% [2/55]; OR 5.30, 95% CI 1.11-25.39, P = 0.037). At week 24, the SRI-4 response was 56.7% (34/60) for telitacicept compared to 40.0% (22/55) for belimumab (OR 1.96, 95% CI 0.93-4.12, P = 0.075). Univariate Cox analysis indicated a superior cumulative SRI-4 incidence for telitacicept (HR 3.03, 95% CI 1.30-7.08, P = 0.011). Multivariable analysis confirmed baseline SLEDAI-2 K (HR 1.29, 95% CI 1.17-1.42, P = 0.001) and serum albumin levels (HR 1.16, 95% CI 1.08-1.24, P = 0.001) as independent predictors of SRI-4 achievement. The incidence of total adverse events was comparable between the telitacicept and belimumab groups (38.3% [23/60] vs. 34.6% [19/55], P = 0.675). In clinical practice, telitacicept is associated with earlier SRI-4 attainment compared to belimumab in patients with active SLE. Baseline disease activity scores and serum albumin levels are key prognostic markers for achieving therapeutic response. Key Points • Telitacicept is associated with a significantly more rapid attainment of the SRI-4 response compared to belimumab in patients with active systemic lupus erythematosus in a real-world setting. • Baseline SLEDAI-2 K scores and serum albumin levels are identified as independent predictors for achieving early therapeutic responses. • The two BAFF/APRIL inhibitors exhibit distinct hematological impacts: telitacicept significantly improves hemoglobin levels, while belimumab is more effective at increasing platelet counts. • A higher dose of telitacicept (160 mg) may facilitate superior long-term attainment of the lupus low disease activity state (LLDAS) compared to the standard dose.

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