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20-11-2023 | Lupus Nephritis | ORIGINAL ARTICLE

Response to belimumab among patients with refractory lupus nephritis: a real-world observational retrospective multicenter study

Authors: Shuoyang Zhang, Qian Qiu, Shan Zeng, Hao Li, Liujing Xu, Ligang Jie, Xuejun Hu, Youjun Xiao, Dongying Chen, Zhongping Zhan, Liuqin Liang, Qinghong Yu, Hanshi Xu

Published in: Clinical Rheumatology

Abstract

Objectives

Belimumab is a biological agent approved for the treatment of active lupus nephritis (LN), but its efficacy on refractory lupus nephritis (LN) is unknown. This study aims to evaluate the efficacy and safety of belimumab in Chinese patients with refractory LN.

Methods

This multicenter, observational, and retrospective study enrolled patients with refractory LN who failed induction therapy with steroids, cyclophosphamide, mycophenolate, and calcineurin inhibitors and received 24-week belimumab treatment before data analysis. Treatment outcomes include the overall clinical response (physician judgment, disease activity, organ damage) and renal response (complete renal response, partial renal response, no renal response). Laboratory indices and adverse events were recorded as well.

Results

Of the 45 patients enrolled in the study, 6 (13.3%) achieved complete renal response, 19 (42.2%) achieved partial renal response, and the overall renal response rate was 55.6%. Median rSLEDAI decreased from 12 (IQR 8–12) at baseline to 8 (IQR 4–8) (p < 0.0001), 4 (IQR 4–8) (p < 0.0001) at 12 and 24 weeks. Mean urinary protein decreased more than 50% from 3.2 g/24 h at baseline to 1.0 g/24 h at 24 weeks (p < 0.0001). The conditions of hypoalbuminemia and hypocomplementemia had also gradually improved. The levels of autoantibodies showed a significant downward trend. Additionally, 9 (20.0%) patients successfully reduced the dosage of prednisone to a safe range, and 3 of them achieved their treatment goal of prednisone cessation. The mean prednisone dosage decreased from 32.7 mg/day at baseline to 18.6 mg/day (p < 0.0001), 13.3 mg/day (p < 0.0001) at 12 and 24 weeks. There were 3 adverse events reported, including 2 cases of infection, and 1 case of allergy. No serious events occurred during the follow-up.

Conclusions

Belimumab is effective and safe when used in clinical practice, which can be considered as an add-on therapy for refractory LN.

Key Points

• A multicenter observational study in the real clinical settings of China.

• First revealed the efficacy and safety of belimumab in Chinese patients with refractory LN.

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Title: Response to belimumab among patients with refractory lupus nephritis: a real-world observational retrospective multicenter study
Authors: Shuoyang Zhang
Qian Qiu
Shan Zeng
Hao Li
Liujing Xu
Ligang Jie
Xuejun Hu
Youjun Xiao
Dongying Chen
Zhongping Zhan
Liuqin Liang
Qinghong Yu
Hanshi Xu
Publication date: 20-11-2023
Publisher: Springer International Publishing
Keywords: Lupus Nephritis
Systemic Lupus Erythematosus
Mycophenolate Mofetil
Glucocorticoid
Published in: Clinical Rheumatology
Print ISSN: 0770-3198
Electronic ISSN: 1434-9949
DOI: https://doi.org/10.1007/s10067-023-06817-z

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