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Lupus, Vol. 17, No. 7, 638-644 (2008)
DOI: 10.1177/0961203308089408


research-article

Induction treatment of proliferative lupus nephritis with leflunomide combined with prednisone: a prospective multi-centre observational study

HY Wang

Renal Division, Peking University First Hospital, Beijing, China

TG Cui

Renal Division, Peking University First Hospital, Beijing, China

FF Hou

Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China

ZH Ni

Renal Division, Renji Hospital, Shanghai Jiaotong University, Shanghai, China

XM Chen

Department of Nephrology, Kidney Center and key Lab of PLA, Chinese General Hospital of PLA, Beijing, China

FM Lu

Renal Division, Huashan Hospital, Fudan University, Shanghai, China

FF Xu

Renal Division, First Affiliated Hospital of Wenzhou Medical College, Wenzhou, China

XQ Yu

Renal Division, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

FS Zhang

Department of Rheumatology, The Second Affiliated Hospital, Harbin Medical University, Harbin, China

XZ Zhao

Department of Nephrology, Shanghai Changzheng Hospital, Shanghai, China

MH Zhao

Renal Division, Peking University First Hospital, Beijing, China

GB Wang

Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China

JQ Qian

Renal Division, Renji Hospital, Shanghai Jiaotong University, Shanghai, China

GY Cai

Department of Nephrology, Kidney Center and key Lab of PLA, Chinese General Hospital of PLA, Beijing, China

TY Zhu

Renal Division, Huashan Hospital, Fudan University, Shanghai, China

YH Wang

Renal Division, First Affiliated Hospital of Wenzhou Medical College, Wenzhou, China, why{at}bjmu.edu.cn

ZP Jiang

Renal Division, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

YN Li

Department of Rheumatology, The Second Affiliated Hospital, Harbin Medical University, Harbin, China

CL Mei

Department of Nephrology, Shanghai Changzheng Hospital, Shanghai, China

WZ Zou

Renal Division, Peking University First Hospital, Beijing, China

To evaluate the efficacy and safety of leflunomide in the treatment of proliferative lupus nephritis, a prospective multi-centre observational study was conducted. Patients with biopsy proven proliferative lupus nephritis were assigned to receive either leflunomide or cyclophosphamide with concomitant prednisone. Leflunomide was given orally with a loading dose of 1 mg/kg/day for 3 days followed by 30 mg/day. Intravenous cyclophosphamide was administered monthly at a dose of 0.5 g/m2 of body-surface area. A total of 110 patients were enrolled, 70 in the leflunomide group and 40 in the cyclophosphamide group. The complete remission rate in the leflunomide group was 21% and partial remission rate 52%, as compared with 18% and 55%, respectively, in the cyclophosphamide group. Renal parameters and systemic lupus erythematosus disease activity index improved significantly and similarly in both groups. Serum creatinine decreased or stabilized in both treatment groups. No significant difference was noted with respect to clinical outcome between groups. Repeat biopsy also showed a significant reduction of active lesions in kidney pathology after 6 months of leflunomide treatment. Major adverse events, similar in both treatment groups, included infection, alopecia and hypertension. Leflunomide, compared with cyclophosphamide, in combination with prednisone was effective in the induction therapy of proliferative lupus nephritis and was generally well-tolerated.

Key Words: leflunomide • lupus nephritis • multi-centre observational study


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