A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus

作者：Ronald van Vollenhoven, Li Wang, Joan T. Merrill, Yi Liu, Chunde Bao, LI Fen, Jiankang Hu, Chenghui Huang, Jianhong Zhao, Cibo Huang, Hanyou Mo, Wei Wei, Lu Fang, Jingyang Li, Dongbao Zhao, Wenxiang Wang, Lin Li, Qing Zuraw, Xiaofei Wang, Xuebin Wang, Jianmin Fang, Fengchun Zhang · 发表于：New England Journal of Medicine · 年份：2025 · DOI：10.1056/nejmoa2414719 · 被引用次数：36 · 研究领域：Systemic Lupus Erythematosus Research、T-cell and B-cell Immunology、Rheumatoid Arthritis Research and Therapies

BACKGROUND: Telitacicept, a new dual inhibitor of the cytokines B-lymphocyte stimulator (BLyS) and APRIL (a proliferation-inducing ligand), showed efficacy in adults with active systemic lupus erythematosus (SLE) in a phase 2b trial when added to standard therapy. METHODS: We conducted a phase 3 trial in China in which participants with active SLE were randomly assigned (in a 1:1 ratio) to receive telitacicept (160 mg) or placebo subcutaneously once weekly for 52 weeks, in addition to standard therapy. The primary end point at week 52 was a response on the modified SLE Responder Index 4 (SRI-4), with a response on this composite measure defined as a reduction of at least 4 points in the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score (ranging from 0 to 105, with higher scores indicating greater disease activity), no new disease activity as measured on the British Isles Lupus Assessment Group index, and no worsening in the Physician's Global Assessment score. RESULTS: Of 433 adults screened, 335 underwent randomization (167 to the telitacicept group and 168 to the placebo group). At week 52, significantly more participants receiving telitacicept had a response on the modified SRI-4 than those receiving placebo (67.1% vs. 32.7%; adjusted difference, 34.5 percentage points; 95% confidence interval [CI], 24.3 to 44.7; P<0.001). A reduction of at least 4 points from baseline in the SELENA-SLED...