Long-term efficacy and safety of belimumab in children with systemic lupus erythematosus: a meta-analysis of real-world data

OBJECTIVES: Belimumab is the first biologic approved for children aged over 5 years with systemic lupus erythematosus (SLE); however, evidence on its long-term efficacy and safety remains limited. This meta-analysis synthesized available data to provide quantitative evidence for clinical decision-making. METHODS: PubMed, Embase, Cochrane Library, and Wanfang databases were searched for studies reporting belimumab outcomes in pediatric SLE. Random-effects models were used for single-arm analyses, and risk ratios (RRs) and mean differences (MDs) were calculated for double-arm comparisons. RESULTS: Sixteen cohort studies and trials were included. Belimumab reduced the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score by 10.16 points at 6 months and 17.71 points at 12 months from baseline. LLDAS was achieved 42% at 6 months and 79% at 12 months. Mean glucocorticoid dose decreased by 19.88 mg/day at 6 months and 11.84 mg/day at 12 months. The 12-month flare rate was 7%, and adverse event (AE) rates were 12% and 46% at 6 and 12 months, respectively. In lupus nephritis (LN), complete remission occurred in 88% at 6 months and 94% at 12 months. Compared with standard immunotherapy, belimumab produced significant greater SLEDAI score reduction (MD, 2.86; p < 0.001), fewer AEs (RR, 0.37; p = 0.004), and higher LN remission rates (RR, 1.26; p = 0.03) at 6 months and lower flare risk at 12 months (RR, 0.44; p = 0.02). CONCLUSION: In pediatric SLE, add-on belimumab improves disease control and safety at 6 months and reduces flare risk at 12 months compared with standard immunotherapy. SYSTEMATIC REVIEW REGISTRATION: PROSPERO: https://www.crd.york.ac.uk/prospero, CRD420251142943.