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Background <p>Belimumab is approved for treating systemic lupus erythematosus (SLE) in children over 5&#xa0;years old; however, its efficacy and safety in pediatric SLE patients require further validation. This study aimed to&#xa0;evaluate&#xa0;the&#xa0;impact&#xa0;of belimumab on the long-term cumulative probability of sustained renal response&#xa0;and&#xa0;disease flare&#xa0;in children with lupus nephritis (LN),&#xa0;to inform clinical decision-making.</p> Methods <p>We included a total of 96 children with LN in our study. The patients were part of a prospective cohort study and were divided into two groups: belimumab group (68 cases) and standard treatment (group (28 cases). We compared remission rates, flare rates, and adverse event incidence between these two&#xa0;groups.</p> Results <p>After 152&#xa0;weeks of follow-up, belimumab increased the renal response and complete renal response rates by 16.7% [odds ratios (OR) = 5.38 (1.33, 15.12)] and 24.7% [OR = 2.74 (1.04, 7.19)]. Belimumab significantly reduced the risk of LN flare, with a 46.2% lower flare rate in the belimumab group compared to the standard treatment group. There was no significant difference in long-term cumulative probability of complete remission between the belimumab and standard treatment groups (<i>P</i> = 0.081), and&#xa0;the&#xa0;standard treatment group had a higher flare rate (<i>P</i> = 0.004).</p> Conclusions <p>Adding belimumab to&#xa0;standard treatment may effectively maintain long-term kidney function and reduce LN flares, making it an effective and safe biologic agent.</p> Graphical abstract <p></p>

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Sustained renal response with belimumab in children with new-onset lupus nephritis

  • 期刊论文

  • 发表日期：

    2025年11月13日

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  • Ren Wang,
  • Tao Sun,
  • Zhuo Shi,
  • Xiang Fang,
  • Xiao Yang,
  • Yu Zhou,
  • Qianhuining Kuang,
  • Jun Yao,
  • Jingjing Wang,
  • ZhiQiang Zhang,
  • Zhengkun Xia,
  • Chunlin Gao,
  • Pei Zhang

摘要

Background

Belimumab is approved for treating systemic lupus erythematosus (SLE) in children over 5 years old; however, its efficacy and safety in pediatric SLE patients require further validation. This study aimed to evaluate the impact of belimumab on the long-term cumulative probability of sustained renal response and disease flare in children with lupus nephritis (LN), to inform clinical decision-making.

Methods

We included a total of 96 children with LN in our study. The patients were part of a prospective cohort study and were divided into two groups: belimumab group (68 cases) and standard treatment (group (28 cases). We compared remission rates, flare rates, and adverse event incidence between these two groups.

Results

After 152 weeks of follow-up, belimumab increased the renal response and complete renal response rates by 16.7% [odds ratios (OR) = 5.38 (1.33, 15.12)] and 24.7% [OR = 2.74 (1.04, 7.19)]. Belimumab significantly reduced the risk of LN flare, with a 46.2% lower flare rate in the belimumab group compared to the standard treatment group. There was no significant difference in long-term cumulative probability of complete remission between the belimumab and standard treatment groups (P = 0.081), and the standard treatment group had a higher flare rate (P = 0.004).

Conclusions

Adding belimumab to standard treatment may effectively maintain long-term kidney function and reduce LN flares, making it an effective and safe biologic agent.

Graphical abstract