Objectives This study aims to evaluate the efficacy and safety of adjunctive Belimumab therapy compared to standard therapy alone in patients with lupus nephritis (LN) within a real-world clinical setting. Methods This single-center, retrospective observational study included patients with LN from January 2020 to December 2023. A total of 64 patients received belimumab as an adjunct to standard therapy. Patients were stratified into induction and maintenance treatment groups by renal remission status at belimumab initiation. A matched control group (n = 64) with comparable baseline characteristics was established. Clinical efficacy and safety were assessed by disease activity, glucocorticoid tapering, renal and extra-renal relapse rates, and treatment-emergent adverse events. Results During the induction phase in patients with LN, belimumab did not significantly enhance remission rates within the first six months. However, during maintenance therapy, belimumab effectively reduced disease activity, facilitated glucocorticoid tapering, and significantly decreased renal relapse rates. Furthermore, belimumab increased the cumulative rate of complete renal remission, improved lupus low disease activity state achievement, and slowed the decline in estimated glomerular filtration rate, with a more pronounced benefit observed in adolescents. The overall incidence of adverse events was comparable between the belimumab and control groups, whereas treatment-related comorbidities were reduced in the belimumab group. Conclusion Belimumab demonstrates a favorable safety profile and contributes to the long-term management of LN, particularly in adolescents. These findings support its potential role as an effective adjunctive therapy for LN.<Table Float="No" ID="Taba"> <tgroup cols="2"> <colspec align="justify" colname="c1" colnum="1" /> <colspec align="justify" colname="c2" colnum="2" /> <tbody> <row> <entry nameend="c2" namest="c1"> Key Points • Belimumab significantly reduces renal relapse, facilitates glucocorticoid tapering, and helps preserve long-term renal function in lupus nephritis maintenance therapy. • Adolescent patients with lupus nephritis represent a key subgroup that derives pronounced therapeutic advantages from adjunctive belimumab treatment. • Belimumab is associated with fewer treatment-related comorbidities compared to standard therapy alone, supporting its safety in real-world use. </entry> </row> </tbody> </tgroup> </Table>

Efficacy and safety of belimumab in lupus nephritis: a real-world retrospective observational study stratified by treatment phase and age

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发表日期：

2026年3月11日

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Shuting Hou,
Zhenlin Tang,
Xiaodi Zhou,
Jiaxiang Shang,
Xinyi Zhao,
Ruixia Ma

摘要

Objectives

This study aims to evaluate the efficacy and safety of adjunctive Belimumab therapy compared to standard therapy alone in patients with lupus nephritis (LN) within a real-world clinical setting.

Methods

This single-center, retrospective observational study included patients with LN from January 2020 to December 2023. A total of 64 patients received belimumab as an adjunct to standard therapy. Patients were stratified into induction and maintenance treatment groups by renal remission status at belimumab initiation. A matched control group (n = 64) with comparable baseline characteristics was established. Clinical efficacy and safety were assessed by disease activity, glucocorticoid tapering, renal and extra-renal relapse rates, and treatment-emergent adverse events.

Results

During the induction phase in patients with LN, belimumab did not significantly enhance remission rates within the first six months. However, during maintenance therapy, belimumab effectively reduced disease activity, facilitated glucocorticoid tapering, and significantly decreased renal relapse rates. Furthermore, belimumab increased the cumulative rate of complete renal remission, improved lupus low disease activity state achievement, and slowed the decline in estimated glomerular filtration rate, with a more pronounced benefit observed in adolescents. The overall incidence of adverse events was comparable between the belimumab and control groups, whereas treatment-related comorbidities were reduced in the belimumab group.

Conclusion

Belimumab demonstrates a favorable safety profile and contributes to the long-term management of LN, particularly in adolescents. These findings support its potential role as an effective adjunctive therapy for LN.

Key Points

• Belimumab significantly reduces renal relapse, facilitates glucocorticoid tapering, and helps preserve long-term renal function in lupus nephritis maintenance therapy.

• Adolescent patients with lupus nephritis represent a key subgroup that derives pronounced therapeutic advantages from adjunctive belimumab treatment.

• Belimumab is associated with fewer treatment-related comorbidities compared to standard therapy alone, supporting its safety in real-world use.