摘要
目的:探索性观察奥妥珠单抗(OBZ)治疗难治及复发性狼疮肾炎(LN)患者的临床疗效与安全性。方法:回顾性分析2023年11月至2024年12月于国家肾脏疾病临床医学研究中心接受OBZ治疗的LN患者资料。治疗方案:第1天、第15天接受1.0 g OBZ,第6个月根据缓解情况或B细胞重建决定是否追加OBZ。主要结局为累积肾脏缓解率。结果:共纳入9例患者(复发7例,难治2例),女性8例。中位随访12个月,所有患者均获得肾脏缓解,其中4例获得完全肾脏缓解(CRR)。治疗6个月时尿蛋白定量由基线1.97(1.78~8.94)g/d降至0.79(0.46~1.09)g/d,血清补体及系统性红斑狼疮疾病活动指数(SLE-DAI)评分均明显改善,肾功能保持稳定。治疗3个月所有患者外周血B细胞均呈完全耗竭状态,6个月仅1例患者出现B细胞重建。9个月时泼尼松剂量降至7.5 mg/d。治疗期间无严重不良事件发生。结论:OBZ治疗难治及复发性LN患者,能够有效获得肾脏缓解,改善免疫学指标及SLE疾病活动,治疗期间耐受性及安全性良好。仍需前瞻性大样本研究进一步证实OBZ在这类患者中的疗效。
Objective:To evaluate the clinical efficacy and safety of Obinutuzumab(OBZ)in the treatment of patients with refractory and relapsing lupus nephritis(LN).Methodology:We retrospectively analyzed data from LN patients treated with OBZ at the National Clinical Research Center for Kidney Diseases from November 2023 to December 2024.Treatment regimen:1.0 g of OBZ was administered on days 1 and 15,whether to administer additional OBZ was based on remission status or B-cell reconstitution at month 6.The primary outcome was the cumulative renal response rate.Results:A total of 9 patients were included(7 relapsing LN,2 refractory LN)with 8 females.The median follow-up was 12 months.All patients achieved renal response,and 4 patiens acheived complete renal response(CRR).At month 6,the median proteinuria decreased from a baseline of 1.97(1.78~8.94)g/d to 0.79(0.46~1.09)g/d.Serum complement levels and Systemic Lupus Erythematosus Disease Activity Index(SLE-DAI)scores showed significant improvement,while renal function remained stable.All patients achieved complete peripheral B-cell depletion within 3 months,with only one patient showing reconstitution at month 6.The median prednisone dosage was tapered to 7.5 mg/d by month 9.No serious adverse events occurred during the treatment period.Conclusion:OBZ therapy could effectively improve renal response in patients with refractory and relapsing LN,with alleviated immunological parameters and disease activity.The patients showed favorable tolerability and safety during the treatment.The large prospective studies are needed to confirm the efficacy of OBZ in these special patients.
作者
张芮枫
王晶晶
汪欣悦
陈独群
涂远茂
章海涛
ZHANG Ruifeng;WANG Jingjing;WANG Xinyue;CHEN Duqun;TU Yuanmao;ZHANG Haitao(National Clinical Research Center for Kidney Diseases,Jinling Hospital,Affiliated Hospital of Medical School,Nanjing University,Nanjing 210016,China)
出处
《肾脏病与透析肾移植杂志》
2025年第6期518-523,共6页
Chinese Journal of Nephrology,Dialysis & Transplantation
基金
国家重点研发计划项目(2024YFC2511002)
院管课题临床研究专项(2024LCYXXH009)。
