Yuan An1, Yunshan Zhou1, Liqi Bi2, Bo Liu2, Hong Wang3, Jin Lin4, Danyi Xu4, Mei Wang5, Jing Zhang5, Yongfu Wang6, Yan An6, Ping Zhu7, Ronghua Xie7, Zhiyi Zhang8, Yifang Mei8, Xiangyuan Liu9, Xiaoli Deng9, Zhongqiang Yao9, Zhuoli Zhang10, Yu Wang10, Weiguo Xiao11, Hui Shen11, Xiuyan Yang12, Hanshi Xu12, Feng Yu13, Guochun Wang14, Xin Lu14, Yang Li15, Yingnan Li15, Xiaoxia Zuo16, Yisha Li16, Yi Liu17, Yi Zhao17, Jianping Guo1, Lingyun Sun3, Minghui Zhao13, Zhanguo Li18. 1. Department of Rheumatology and Immunology, Peking University People's Hospital, 11 Xizhimen South Street, Xicheng District, Beijing, 100044, China. 2. Department of Rheumatology, China Japan Union Hospital, Jilin University, Changchun, China. 3. Department of Rheumatology and Immunology, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China. 4. Department of Rheumatology and Immunology, First Affiliated Hospital, Zhejing University, Hangzhou, China. 5. Department of Nephrology, Peking University People's Hospital, Beijing, China. 6. Department of Rheumatology, First Affiliated Hospital of Baotou Medical College, Baotou, China. 7. Department of Clinical Immunology, Fourth Military Medical University Xijing Hospital, Xi'an, China. 8. Department of Rheumatology and Immunology, The First Affiliated Hospital of Harbin Medical University, Harbin, China. 9. Department of Rheumatology and Immunology, Peking University Third Hospital, Beijing, China. 10. Department of Rheumatology and Immunology, Peking University First Hospital, Beijing, China. 11. Department of Rheumatology and Immunology, First Affiliated Hospital of China Medical University, Shenyang, China. 12. Department of Rheumatology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. 13. Department of Nephrology, Peking University First Hospital, Beijing, China. 14. Department of Rheumatology and Immunology, China-Japan Friendship Hospital, Beijing, China. 15. Department of Rheumatology and Immunology, Second Clinical Hospital, Harbin Medical University, Harbin, China. 16. Department of Rheumatology and Immunology, Xiangya Hospital Central South University, Changsha, China. 17. Department of Rheumatology and Immunology, West China Hospital, Sichuan University, Chengdu, China. 18. Department of Rheumatology and Immunology, Peking University People's Hospital, 11 Xizhimen South Street, Xicheng District, Beijing, 100044, China. zgli99@aliyun.com.
Abstract
OBJECTIVES: The standard strategy for treating lupus nephritis comprises glucocorticoids together with either intravenous cyclophosphamide or oral mycophenolate mofetil, but the low remission rate is still a challenge in practice. This study was aimed to seek higher remission rate of lupus nephritis using a combined strategy. METHOD: A 24-week trial was conducted in 17 rheumatology or nephrology centers in China. A total of 191 lupus nephritis patients were randomized to follow a combined immunosuppressive treatment (CIST) with intravenous cyclophosphamide, an oral immunosuppressive agent, namely mycophenolate mofetil, azathioprine or leflunomide, and hydroxychloroquine (n = 95), or receive intravenous cyclophosphamide alone (n = 96) for 24 weeks. Glucocorticoid was given to both groups. The primary end point was a complete remission with a most stringent standard as proteinuria < 150 mg per 24 h, normal urinary sediment, serum albumin, and renal function at 24 weeks. The secondary end point was treatment failure at 24 weeks. RESULTS: At week 24, both the rate of complete remission (39.5%) and total response (87.2%) was higher in the combined group, compared with CYC group (20.8% and 68.8%, p < 0.05). The cumulative probability of complete remission was also higher in the combined group (p = 0.013). In addition, the combined treatment was superior to routine CYC with less treatment failure (12.8% vs.31.2%, p < 0.001). No difference was found between the incidences of severe adverse events in the two arms: 3.2% (3/95 combined group) vs.4.2% (4/96 CYC group). CONCLUSION: Treatment with a combined immunosuppressive agent is superior to routine CYC only therapy in lupus nephritis.
RCT Entities:
OBJECTIVES: The standard strategy for treating lupus nephritis comprises glucocorticoids together with either intravenous cyclophosphamide or oral mycophenolate mofetil, but the low remission rate is still a challenge in practice. This study was aimed to seek higher remission rate of lupus nephritis using a combined strategy. METHOD: A 24-week trial was conducted in 17 rheumatology or nephrology centers in China. A total of 191 lupus nephritispatients were randomized to follow a combined immunosuppressive treatment (CIST) with intravenous cyclophosphamide, an oral immunosuppressive agent, namely mycophenolate mofetil, azathioprine or leflunomide, and hydroxychloroquine (n = 95), or receive intravenous cyclophosphamide alone (n = 96) for 24 weeks. Glucocorticoid was given to both groups. The primary end point was a complete remission with a most stringent standard as proteinuria < 150 mg per 24 h, normal urinary sediment, serum albumin, and renal function at 24 weeks. The secondary end point was treatment failure at 24 weeks. RESULTS: At week 24, both the rate of complete remission (39.5%) and total response (87.2%) was higher in the combined group, compared with CYC group (20.8% and 68.8%, p < 0.05). The cumulative probability of complete remission was also higher in the combined group (p = 0.013). In addition, the combined treatment was superior to routine CYC with less treatment failure (12.8% vs.31.2%, p < 0.001). No difference was found between the incidences of severe adverse events in the two arms: 3.2% (3/95 combined group) vs.4.2% (4/96 CYC group). CONCLUSION: Treatment with a combined immunosuppressive agent is superior to routine CYC only therapy in lupus nephritis.
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Authors: F A Houssiau; C Vasconcelos; D D'Cruz; G D Sebastiani; E de Ramon Garrido; M G Danieli; D Abramovicz; D Blockmans; A Cauli; H Direskeneli; M Galeazzi; A Gül; Y Levy; P Petera; R Popovic; R Petrovic; R A Sinico; R Cattaneo; J Font; G Depresseux; J-P Cosyns; R Cervera Journal: Ann Rheum Dis Date: 2010-01 Impact factor: 19.103