Department of Nephrology, Nanfang Hospital, 198153Southern Medical University; National Clinical Research Center for Kidney Disease, Nanfang Hospital; State Key Laboratory of Organ Failure Research, Southern Medical University; Guangdong Provincial Institute of Nephrology; Guangdong Provincial Key Laboratory of Renal Failure Research; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou, China.
Department of Nephrology, 364187The Second People's Hospital of Guizhou Province, Guangzhou, China.
Lupus. 2022 Oct;31(12):1456-1467. doi: 10.1177/09612033221119123. Epub 2022 Aug 12.
Systemic lupus erythematosus is a chronic inflammatory autoimmune disease that has various manifestations. Lupus nephritis is a common and severe presentation, which results in increased morbidity and mortality. Belimumab added on standard therapy has been proved to induce disease remission and improve renal parameters. However, the use of belimumab has not been explored in patients requiring dialysis treatment.
Seven patients diagnosed as SLE with renal involvement requiring dialysis, who received belimumab in addition to steroids or immunosuppressants were identified. Clinical and biological data were extracted from medical records and laboratory databases. Ten mg/kg belimumab was applied on day 1, 15, 29, and every 28 days thereafter for a total of 8 dose. Renal parameters including urine output and serum creatinine level, immunologic index including anti-ds-DNA antibody titer and complement level, and disease activity were documented to reveal the response to belimumab.
After belimumab therapy, all the 7 patients receiving dialysis therapy showed immunologic improvement. Disease activity significantly declined from 16.5 to 5.33 using SLEDAI-2K score. Apart from patient 7 on maintenance dialysis, 5 of 6 patients had increased urine output and were out of dialysis treatment. Patient 5 and 6 showed significant decrease in serum creatinine level. Only one pulmonary infection was documented.
Belimumab added to steroids or immunosuppressive agents was able to improve renal and immunologic parameters and decrease disease activity of SLE patients receiving dialysis treatment. The safety issue is promising with no severe adverse effect recorded. Further large, controlled, randomized clinical trials are required to confirm the results.
系统性红斑狼疮是一种慢性炎症性自身免疫性疾病，其临床表现多样。狼疮肾炎是一种常见且严重的表现，可导致发病率和死亡率增加。在标准治疗的基础上添加贝利尤单抗已被证明可诱导疾病缓解并改善肾脏参数。然而，尚未在需要透析治疗的患者中探索贝利尤单抗的使用。
确定了 7 例被诊断为伴有肾脏受累需要透析的 SLE 患者，这些患者在接受类固醇或免疫抑制剂治疗的基础上还接受了贝利尤单抗治疗。从病历和实验室数据库中提取了临床和生物学数据。第 1、15、29 天及第 28 天（此后每 28 天）给予 10mg/kg 的贝利尤单抗，共 8 个剂量。记录了肾脏参数（尿量和血清肌酐水平）、免疫指标（抗 ds-DNA 抗体滴度和补体水平）和疾病活动度，以揭示对贝利尤单抗的反应。
在接受贝利尤单抗治疗后，所有接受透析治疗的 7 例患者的免疫功能均得到改善。SLEDAI-2K 评分从 16.5 分降至 5.33 分，疾病活动度显著下降。除了维持性透析的患者 7 外，6 例中有 5 例患者的尿量增加，已脱离透析治疗。患者 5 和 6 的血清肌酐水平显著下降。仅记录了 1 例肺部感染。
在类固醇或免疫抑制剂治疗的基础上添加贝利尤单抗可改善接受透析治疗的 SLE 患者的肾脏和免疫参数，并降低疾病活动度。安全性问题有希望，没有记录到严重的不良反应。需要进一步开展大型、对照、随机临床试验来证实这些结果。
