02955nam a2200313 4500 ESSALUD 20260902161050.0 ta t pe ||||| |||| 00| 0 spa d BMG eng Lv, Jicheng 54473 Telitacicept for IgA nephropathy — interim Analysis of a phase 3 trial páginas: 1916-1924 Background: The pathogenesis of IgA nephropathy is mediated by B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL). Telitacicept is a fusion protein that targets and neutralizes both BAFF and APRIL and, as such, might be effective in IgA nephropathy. Methods: We now report a prespecified interim analysis of a phase 3, multicenter, double-blind, randomized, placebo-controlled trial, which enrolled adults with biopsy-proven IgA nephropathy and persistent proteinuria (protein level, ≥1.0 g per day), despite appropriate supportive care. Patients were randomly assigned in a 1:1 ratio to receive subcutaneous once-weekly telitacicept (240 mg) or matching placebo. The primary end point was the geometric mean ratio of the 24-hour urinary protein-to-creatinine ratio at 39 weeks relative to baseline. Safety was also evaluated. Results: A total of 318 patients were assigned to receive telitacicept or placebo (159 in each group). At week 39, the percentage change in the 24-hour urinary protein-to-creatinine ratio was −58.9% with telitacicept and −8.8% with placebo, which corresponded to a relative difference (based on the ratio of geometric mean reductions between the two groups) of −55.0% (95% confidence interval [CI], −61.3 to −47.6; P<0.001) in favor of active medication. The percentage change in the estimated glomerular filtration rate relative to baseline was −1.0% (95% CI, −3.2 to 1.2) with telitacicept and −7.7% (95% CI, −9.9 to −5.4) with placebo. Adverse events were more common with telitacicept than with placebo (in 89.3% vs. 78.6% of patients), although serious adverse events were less common (in 2.5% vs. 8.2%). No unexpected safety findings were reported with telitacicept. Conclusions: In patients with IgA nephropathy at high risk for progression, 39 weeks of treatment with telitacicept led to a greater reduction in the 24-hour urinary protein-to-creatinine ratio than placebo. ENFERMEDAD RENAL CRÓNICA 32213 MEDICINA CLÍNICA GENERAL 53666 ENFERMEDAD GLOMERULAR 54474 NEFROLOGÍA GENERAL 53655 Liu, Lijun 54475 Wang, Wenxiang 54476 Wang, Xinyue 54477 Zuraw, Qing 54478 Perkovic, Vlado 54479 Fang, Jianmin 54480 Zhang, Hong 54481 22717 22669 Massachusetts NEJM Group NEJM014 The New England Journal of Medicine ESSALUD 0028-4793 ARTICULOS 2026-08-31 sqb 22903 22903