Adults with biopsy-proven IgA nephropathy and persistent proteinuria despite supportive care received subcutaneous telitacicept 240 mg once weekly or matching placebo in a randomized, double-blind trial. The primary outcome measured the geometric mean ratio of the 24-hour urinary protein-to-creatinine ratio at 39 weeks relative to baseline. At week 39, urinary protein-to-creatinine ratio decreased substantially with telitacicept compared with placebo, producing a large relative difference favoring telitacicept. Estimated glomerular filtration rate changed slightly with telitacicept and declined more with placebo. Adverse events occurred more frequently with telitacicept, while serious adverse events were less frequent. No unexpected safety findings were reported.
"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."
"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."
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