To investigate the efficacy and safety of belimumab in the treatment of systemic lupus erythematosus (SLE) in a real-world setting and provide a valuable reference for clinical treatment. In this retrospective study, 101 patients with SLE who came to our hospital from March 2020 to September 2022, 56 of whom with lupus nephritis (LN), were selected. All patients received belimumab in combination with standard of care(SoC)therapy regimen for more than 52 weeks and their clinical/laboratory data, assessment of disease activity, glucocorticoids dosage and occurrence of adverse events were recorded. Lupus Low Disease Activity State (LLDAS) and DORIS remission as a primary goal in the treatment of SLE. The groups were classified according to the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2 K): SLEDAI-2 K < 6 was categorized as the mild group (mild activity) and SLEDAI-2 K ≥ 6 was categorized as the active group (moderate-severe activity). The disease of the two groups mentioned above were assessed using the SELENA-SLEDAI Flare Index (SFI) and the SLE Responder Index-4 (SRI-4), respectively. Furthermore, we used complete remission (CR) and partial remission (PR) in the kidney as the standard for efficacy evaluation for LN patients. After 52 weeks of treatment with belimumab, patients’ complement levels increased significantly (p < 0.05); Other indicators such as 24-hour urine protein quantification and daily glucocorticoids dose decreased compared to pretreatment (p < 0.05). At 52 weeks, (i) after evaluation, the whole group of patients showed significant improvement in their condition; (ii) 55.4% of patients achieved LLDAS and 23.8% achieved DORIS remission; (iii) 73.2% of patients with LN achieved CR, 16.1% achieved PR. Adverse reactions were observed in 15 patients (14.9%), all of which normalized after symptomatic treatment. In general, during treatment with belimumab, immunological and biochemical indices improved in SLE patients, urinary protein levels were reduced in LN patients, and the rate of renal function remission was effectively increased; At the same time, the use of belimumab is associated with a low frequency of side effects, good overall tolerability and a favorable safety profile.

中文翻译：

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使用贝利尤单抗治疗系统性红斑狼疮患者：一项单中心、真实世界回顾性研究


探讨贝利尤单抗在现实环境中治疗系统性红斑狼疮（SLE）的有效性和安全性，为临床治疗提供有价值的参考。本回顾性研究选取2020年3月至2022年9月期间来我院就诊的101例SLE患者，其中56例患有狼疮性肾炎（LN）。所有患者均接受贝利尤单抗联合标准护理（SoC）治疗方案超过52周，并记录其临床/实验室数据、疾病活动评估、糖皮质激素剂量和不良事件发生情况。狼疮低疾病活动状态 (LLDAS) 和 DORIS 缓解是 SLE 治疗的主要目标。根据系统性红斑狼疮疾病活动指数 2000 (SLEDAI-2 K) 对各组进行分类：SLEDAI-2 K < 6 被归类为轻度组（轻度活动），SLEDAI-2 K ≥ 6 被归类为活动组组（中度至重度活动）。分别使用SELENA-SLEDAI耀斑指数（SFI）和SLE反应指数4（SRI-4）评估上述两组的疾病。此外，我们以肾脏完全缓解（CR）和部分缓解（PR）作为LN患者疗效评价的标准。使用贝利尤单抗治疗 52 周后，患者的补体水平显着升高 (p < 0.05)；与治疗前相比，其他指标如 24 小时尿蛋白定量和每日糖皮质激素剂量有所下降 (p < 0.05)。 52周时，（i）评估后，全组患者病情明显改善； (ii) 55.4% 的患者达到 LLDAS 缓解，23.8% 的患者达到 DORIS 缓解； (iii) 73.2% 的 LN 患者达到 CR，16.1% 达到 PR。 15例（14.9%）患者出现不良反应，经对症治疗后均恢复正常。总体而言，贝利尤单抗治疗期间，SLE患者的免疫生化指标得到改善，LN患者的尿蛋白水平降低，肾功能缓解率有效提高；同时，贝利尤单抗的使用具有低频率的副作用、良好的总体耐受性和良好的安全性。