02959nam a2200313   4500001000800000005001700008007000300025008004100028040000800069041000800077100002400085245007700109300002500186520196000211650003802171650003802209650003302247650003202280700002202312700002702334700002502361700002402386700002802410700002502438700002402463773011002487942003102597999001702628ESSALUD20260902161050.0ta      t        pe ||||| |||| 00| 0 spa d  aBMG  aeng  aLv, Jicheng 954473  aTelitacicept for IgA nephropathy — interim Analysis of a phase 3 trial  apáginas: 1916-1924  aBackground: 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.   aENFERMEDAD RENAL CRÓNICA932213  aMEDICINA CLÍNICA GENERAL953666  aENFERMEDAD GLOMERULAR954474  aNEFROLOGÍA GENERAL953655  aLiu, Lijun954475  aWang, Wenxiang 954476  aWang, Xinyue 954477  aZuraw, Qing 954478  aPerkovic, Vlado 954479  aFang, Jianmin954480  aZhang, Hong 9544810 022717922669dMassachusetts NEJM GroupoNEJM014tThe New England Journal of Medicine wESSALUDx0028-4793  cARTICULOSe2026-08-31zsqb  c22903d22903