ABS1153 A PHASE 4, MULTICENTRE, OPEN-LABEL STUDY OF INTRAVENOUS BELIMUMAB IN PAEDIATRIC PATIENTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS IN CHINA

作者：Chen Li, Jing Zhang, Honggang Yu, Li Zhu, Siqi Yang, Lu Ma, Qiang Feng, Xiaoli Li, Lixin Sun, Xiaoping Tang, Juan Chen, Chongjian Wang, Deepak Assudani · 发表于：Annals of the Rheumatic Diseases · 年份：2025 · DOI：10.1016/j.ard.2025.06.1928 · 被引用次数：2 · 研究领域：Systemic Lupus Erythematosus Research、Immunodeficiency and Autoimmune Disorders、Monoclonal and Polyclonal Antibodies Research

Background: Belimumab, a human immunoglobulin G1-lambda (IgG1λ) monoclonal antibody that selectively binds to soluble B-lymphocyte stimulator (BLyS), was approved by the China National Medical Products Administration as add-on therapy for adult patients with active systemic lupus erythematosus (SLE) in 2019, and for paediatric patients with active SLE in 2020. Approval for paediatric patients in China was based on extrapolated data from mainly Western paediatric patients [1] and global studies in adult patients, including Northeast Asia [2-4]. This Phase 4 open-label study evaluated the efficacy and safety of intravenous (IV) belimumab in Chinese paediatric patients with SLE, where data are limited. Objectives: To evaluate efficacy and safety of IV belimumab plus standard therapy (ST) in Chinese paediatric patients with active SLE. Methods: This was a multicentre, single-arm, prospective, 52-week study (GSK Study 213560; NCT04908865) of belimumab 10 mg/kg IV in Chinese paediatric patients aged 5–17 years with active SLE, defined as a Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score ≥8 at screening. Belimumab 10 mg/kg IV (plus ST) was administered on Days 0, 14, 28 and then every 28 days to Week 48. The primary efficacy endpoint was the proportion of SELENA-SLEDAI responders (≥4-point reduction from baseline) at Week 52. Secondary efficacy endpoints included: the change from baseline at Wee...