| 초록 |
Objectives: To assess the safety and effectiveness of telitacicept when used in conjunction with immunosuppressive treatment plans for IgAN. Methods: 41 patients who met the inclusion criteria and had 24-hour proteinuria >0.5 g/d with IgAN were screened into two groups: the treatment group (n=20) and the control group (n=21). Both groups receive optimized supportive care for three months, during which time the treatment group receives a subcutaneous injection of 160 mg of telitacicept in addition to 0.5 mg/kg of methylprednisolone and/or mycophenolate mofetil, while the control group does not receive any telitacicept treatment for 24 weeks. The 24-hour proteinuria change at week 24 was the primary endpoint, and the change in eGFR was the secondary goal. Results: Week 24 saw a 58.66% (mean difference -2.27, 95% confidence interval, -0.72to-3.82, p=0.004) decrease in 24-hour proteinuria in the treatment group(Figure), and 22.92% (mean difference -1.93, 95% confidence interval, -2.68to-1.17, p<0.001) decrease in IgG, 44.61% (mean difference -1.20, 95% confidence interval, -1.70to-0.73, p<0.001) decrease in IgA, and 46.79% (mean difference -0.51, 95% confidence interval, -0.73to-0.29, p<0.001) decrease in IgM in the treatment group. The change in 24-hour proteinuria in the control group was observed to be 39.13% lower than the baseline at week 24 (mean difference -0.63, 95% confidence interval, -1.01 to -0.25, p=0.002) (Figure). Both before and after therapy, the eGFR in both groups stayed comparatively constant. Both groups experienced similar adverse events; no serious adverse events were reported. Conclusions: To a certain extent, telitacicept can slow the progression of IgAN by reducing the levels of 24-hour proteinuria, IgG, IgA, and IgM. |