Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics, Beijing, 100020, China.
Eur J Pediatr. 2024 Sep;183(9):3987-3995. doi: 10.1007/s00431-024-05662-9. Epub 2024 Jun 28.
The purpose of this study is to evaluate the efficacy and safety of belimumab combined with the standard regimen in treating children with active lupus nephritis. This single-center, retrospective cohort study used clinical data of children with newly active lupus nephritis hospitalized in the Department of Nephrology between December 2004 and February 2023. Patients were divided into a belimumab or traditional treatment group according to whether or not they received belimumab. Renal remission and recurrence rates and glucocorticoid dose were compared between groups. Forty-seven children (median age 11 years) were enrolled, including 30 and 17 children in the traditional treatment and belimumab groups, respectively. The Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2000) score of children in the belimumab group (23.59 ± 7.78) was higher than that in the traditional treatment group (19.13 ± 6.10) (P = 0.035). The two groups showed no significant difference in the frequency of pyuria, gross hematuria, and the levels of 24-h proteinuria and estimated glomerular filtration rate. The complement C3/C4 in the belimumab group recovered faster than that in the traditional treatment group (P < 0.05). There were no between-group differences in the complete renal remission rate at 6 or 12 months (P = 0.442, P = 0.759). There were no between-group differences in 1-year recurrence rate (P = 0.303). Furthermore, 6 and 12 months after treatment, glucocorticoid doses were lower in the belimumab than the traditional treatment group (17.87 ± 6.96 mg/d vs. 27.33 ± 8.40 mg/d, P = 0.000; 10.00 (5.3) mg/d vs. 13.75 (10.0) mg/d, P = 0.007), respectively.
With an equivalent renal remission rate, belimumab combined with the standard traditional regimen might promote the tapering of glucocorticoids, and the incidence of adverse events is low.
• Belimumab is documented as an adjunctive treatment with systemic lupus erythematosus (c-SLE) LN with efficacy. • Due to the paucity of studies, its effects and side effects in children with LN remain unclear.
• This single-center, retrospective cohort study evaluated the efficacy and safety of belimumab combined with the standard regimen in treating children with proliferative LN. • Belimumab combined with the standard traditional treatment might promote the tapering of glucocorticoids, while exhibiting a low occurrence of adverse events.
目的 本研究旨在评估贝利尤单抗联合标准方案治疗儿童活动性狼疮肾炎的疗效和安全性。
方法 这是一项单中心、回顾性队列研究，使用了 2004 年 12 月至 2023 年 2 月期间在肾脏病科住院的新确诊活动性狼疮肾炎患儿的临床数据。根据是否使用贝利尤单抗，将患儿分为贝利尤单抗或传统治疗组。比较两组患儿的肾脏缓解率和复发率以及糖皮质激素剂量。
结果 共纳入 47 例患儿（中位年龄 11 岁），其中传统治疗组 30 例，贝利尤单抗组 17 例。贝利尤单抗组患儿的系统性红斑狼疮疾病活动指数 2000 评分（SLEDAI-2000）[23.59±7.78]高于传统治疗组[19.13±6.10]（P=0.035）。两组患儿的脓尿、肉眼血尿频率以及 24 h 尿蛋白定量、估计肾小球滤过率水平无显著差异。贝利尤单抗组患儿的补体 C3/C4 恢复更快（P＜0.05）。两组患儿在治疗后 6 个月和 12 个月时的完全肾脏缓解率无显著差异（P=0.442，P=0.759）。两组患儿的 1 年复发率也无显著差异（P=0.303）。治疗后 6 个月和 12 个月时，贝利尤单抗组患儿的糖皮质激素剂量均低于传统治疗组[17.87±6.96 mg/d 比 27.33±8.40 mg/d，P=0.000；10.00（5.3）mg/d 比 13.75（10.0）mg/d，P=0.007]。
结论 与标准传统方案相比，贝利尤单抗联合方案在获得同等肾脏缓解率的同时，可能有助于糖皮质激素的减量，且不良反应发生率较低。
局限性 该研究为回顾性研究，存在选择偏倚。
背景 贝利尤单抗被证明是一种治疗系统性红斑狼疮（c-SLE）相关狼疮肾炎的辅助治疗药物，疗效确切。但由于研究较少，其在儿童狼疮肾炎患者中的疗效和不良反应仍不明确。
重要性 本单中心、回顾性队列研究评估了贝利尤单抗联合标准方案治疗儿童增殖性狼疮肾炎的疗效和安全性。
创新性 贝利尤单抗联合标准传统治疗方案可能有助于糖皮质激素的减量，同时不良反应发生率较低。
