Mizoribine or Cyclophosphamide for Lupus Nephritis

作者：Zheyi Dong, Ping Luo, Shiren Sun, Zhaohui Ni, Yani He, Xiangyang Huang, Zhangsuo Liu, Zhenbiao Wu, X. Zhang, Yunhua Liao, Jianhong Zhao, Hongli Lin, Xiao Zhang, Rongguo Fu, Guohua Ding, Yan Xu, Lihua Wang, Yue-Fei Xiao, Shumei Shi, Xiaoxia Zuo, Zhanguo Li, Li Qiao, Rong Wang, Wenge Li, Jianxin Wan, Ying Li, Tianjun Guan, Xiaoli Deng, Xiaoyan Wu, Hongguang Zheng, Jianghua Chen, Lan He, Seika Yamaguchi, Hua Wang, Guangyan Cai, Li Zhang, Xiangmei Chen · 发表于：JAMA Network Open · 年份：2025 · DOI：10.1001/jamanetworkopen.2025.0648 · 被引用次数：7 · 研究领域：Systemic Lupus Erythematosus Research、Renal Diseases and Glomerulopathies、Rheumatoid Arthritis Research and Therapies

Importance: Lupus nephritis is typically treated with intravenous cyclophosphamide, which is associated with serious adverse effects. Oral mizoribine may be an alternative for induction therapy of lupus nephritis. However, large-scale, long-term, randomized clinical studies of mizoribine are lacking. Objective: To assess the efficacy and safety of oral mizoribine vs intravenous cyclophosphamide as induction therapy for Chinese patients with lupus nephritis. Design, Setting, and Participants: This prospective, multicenter, parallel-group, open-label, phase 3 randomized clinical trial recruited patients with class III, III+V, IV, IV+V, or V lupus nephritis aged 18 to 70 years from 40 centers in China. Inclusion criteria included 24-hour urinary protein level of 1.0 g or higher and systemic lupus erythematosus disease activity index of 8 or higher. The first patient was enrolled on November 29, 2014, and the study finished March 14, 2019. The follow-up period was 52 weeks. Data were analyzed from September 4, 2019, to January 21, 2020. Interventions: Oral mizoribine (50 mg, 3 times a day) or cyclophosphamide (6 intravenous doses at 0.5-1.0 g/m2 body surface area, with a maximum dose of 1.0 g/d) for 52 weeks plus oral glucocorticoid. Main Outcomes and Measures: Total remission rate (complete remission rate plus partial remission rate) after 52 weeks (prespecified). Results: A total of 250 patients were randomized, and 243 patients (mean [SD] age, 34.6 [10.7] years, 213 women [87....