Abstract: ObjectiveTo study the clinical effect of belimumab on children with systemic lupus erythematosus. MethodsA retrospective, real-world clinical study was conducted to analyze the clinical data of CSLE patients who were diagnosed and treated with belimumab for 16 weeks in Henan Province People's Hospital from January 2021 to August 2022. ResultsA total of 11 children (1 boy and 10 girls) were enrolled, and the average age was (13.91±1.70) years. The median course of disease on receiving belimumab was (8.91±10.41) months. After treatment, the proportion of systemic symptoms, skin and mucous membrane, and other system involvement decreased;C3 and C4 returned to normal, the anti-double-stranded DNA(dsDNA) quantitation decreased, and the urinary protein quantitation of 24 hours decreased in children with lupus nephritis. The dosage of prednisone before and after treatment was statistically different（P<0.01）.The difference in systemic lupus erythematosus disease activity index(SLEDAI-2000) and physician's global assessment(PGA) were statistically significant at different time points(0, 2, 4, 8, 12, 16 weeks) after belimumab treatment（P<0.05）.All patients achieved SRI-4 response at 16 weeks. Adverse events occurred in 2 patients(18.18%) during belimumab treatment; hemoglobin and platelet decreased in 1 case after 2 weeks of treatment; and returned to normal after 12 weeks of treatment; 1 case had upper respiratory infection.Conclusion Belimumab is effective in the treatment of CSLE with low incidence of adverse events, and the dose of glucocorticoid is reduced.

Key words: Systemic lupus erythematosus, Belimumab, Clinical effect, Children