Efficacy of initial combination with belimumab in newly diagnosed childhood-onset lupus nephritis: a single-centre historical control study

• Published in: Lupus science & medicine 2024-12, Vol.11 (2), p.e001350
• Main Authors: Gong, Yinv, Liu, Shuhua, Liu, Haimei, Shi, Yu, Li, Yifan, Guan, Wanzhen, Zeng, Qiaoqian, Lv, Qianying, Zhang, Xiaomei, Wei, Qijiao, Chen, Jing, Shen, Qian, Xu, Hong, Sun, Li
• Format: Article
• Language: English
• Subjects: Adolescent; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - therapeutic use; Anticoagulants; Biological Products; Child; Child, Preschool; Childhood Lupus; Clinical trials; Creatinine; Cyclophosphamide - administration & dosage; Cyclophosphamide - adverse effects; Cyclophosphamide - therapeutic use; Drug dosages; Drug Therapy, Combination; Female; Glucocorticoids - administration & dosage; Glucocorticoids - therapeutic use; Humans; Immunosuppressive agents; Immunosuppressive Agents - administration & dosage; Immunosuppressive Agents - adverse effects; Immunosuppressive Agents - therapeutic use; Immunotherapy; Lupus; Lupus Erythematosus, Systemic; Lupus Nephritis; Lupus Nephritis - drug therapy; Male; Medical diagnosis; Medical prognosis; Mycophenolic Acid - therapeutic use; Nephrology; Oral administration; Original Research; Pediatrics; Proteins; Remission (Medicine); Remission Induction; Rheumatology; Severity of Illness Index; Tacrolimus - administration & dosage; Tacrolimus - adverse effects; Tacrolimus - therapeutic use; Treatment Outcome; Urine
• ISSN: 2053-8790; 2053-8790
• DOI: 10.1136/lupus-2024-001350

ObjectiveTo explore the efficacy of initial treatment of newly diagnosed childhood-onset lupus nephritis (cLN) with combination of belimumab and either cyclophosphamide, mycophenolate mofetil, tacrolimus or multitargeted therapy.MethodsA historical control study was conducted on children aged 5–17 years with newly diagnosed cLN. All patients recruited met the 2012 Systemic Lupus International Collaborating Clinics and/or 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for SLE, and the 2003 International Society of Nephrology/Renal Pathology Society histopathological criteria for LN. The primary endpoint was primary efficacy renal response (PERR) at 12 months, and secondary endpoints included complete renal response (CRR), lupus low disease activity state (LLDAS) and remission (Definitions of Remission in Systemic Lupus Erythematosus (DORIS)) at 12 months, changes of SLE Disease Activity Index (SLEDAI) and dose of glucocorticoid (GC).ResultsA total of 101 patients were included with 38 patients in the belimumab group and 63 patients in the standard immunotherapy group. There were no statistically significant differences between the two groups at baseline. At 12 months, compared with the standard immunotherapy group, more patients in the belimumab group had a higher PERR (97.1% vs 80.0%, χ2=3.965, p=0.046), CRR (94.1% vs 76.6%, χ2=4.679, p=0.031), LLDAS (75.0% vs 18.6%, χ2=27.84, p