000			02955nam a2200313 4500
001			ESSALUD
005			20260902161050.0
007			ta
008			t pe ||||| |||| 00| 0 spa d
040			_aBMG
041			_aeng
100			_aLv, Jicheng _954473
245			_aTelitacicept for IgA nephropathy — interim Analysis of a phase 3 trial
300			_apáginas: 1916-1924
520			_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.
650			_aENFERMEDAD RENAL CRÓNICA _932213
650			_aMEDICINA CLÍNICA GENERAL _953666
650			_aENFERMEDAD GLOMERULAR _954474
650			_aNEFROLOGÍA GENERAL _953655
700			_aLiu, Lijun _954475
700			_aWang, Wenxiang _954476
700			_aWang, Xinyue _954477
700			_aZuraw, Qing _954478
700			_aPerkovic, Vlado _954479
700			_aFang, Jianmin _954480
700			_aZhang, Hong _954481
773	0		_022717 _922669 _dMassachusetts NEJM Group _oNEJM014 _tThe New England Journal of Medicine _wESSALUD _x0028-4793
942			_cARTICULOS _e2026-08-31 _zsqb
999			_c22903 _d22903