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已发表论文
利妥昔单抗治疗成人微小病变病和局灶节段性肾小球硬化症的疗效和安全性：一项与糖皮质激素对比的前瞻性研究
Authors Zhao YX , Li X , Cheng X , Pan Y, Liu L
Received 26 June 2025
Accepted for publication 27 October 2025
Published 27 November 2025 Volume 2025:19 Pages 10571—10587
DOI https://doi.org/10.2147/DDDT.S549834
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Tuo Deng
Yong Xin Zhao, Xi Li, Xu Cheng, Yan Pan, Lei Liu
Department of Nephrology, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, 233004, People’s Republic of China
Correspondence: Yan Pan, Email py19841205@163.com Lei Liu, Email bbmcll@163.com
Background: Minimal Change Disease (MCD) / Focal Segmental Glomerulosclerosis (FSGS) are leading causes of adult nephrotic syndrome. Roughly half of patients need long-term immunosuppression for steroid dependence or relapse, but traditional drugs carry substantial adverse effects. Rituximab (RTX) depletes CD20⁺ B cells and reduces anti-podocyte antibodies; pediatric data are encouraging, yet direct adult evidence—especially between treatment-naïve and relapsed patients—remains scarce.
Methods: This study enrolled 82 patients with MCD/FSGS diagnosed between 2020 and 2023, divided into the RTX group (24 patients, 9 treatment-naïve and 15 relapsed) and the glucocorticoid group (58 patients). The RTX group received standard-dose RTX (375 mg/m2 weekly for 4 weeks), while the glucocorticoid group was treated with prednisone (1 mg/kg/day). Outcomes were compared using t-tests, χ2/Fisher, logistic regression, and Kaplan–Meier analyses.
Results: The overall remission rates were 100% in the RTX group and 98.3% in the glucocorticoid group (P=0.876), but the RTX group had a significantly higher eGFR at the last follow-up (124.25 vs 109.00 mL/min/1.73 m2, P=0.019). A statistically significant intergroup difference was also observed, with complete remission achieved in 89.5% of MCD patients versus 40% of FSGS patients (P< 0.05). In relapsed patients treated with RTX, prednisone dosage decreased from 34.0± 15.7 mg/day to 7.7± 7.8 mg/day (P< 0.001), annual relapse frequency dropped from 1.0 to 0 episodes/year (P=0.001), and 40% of patients completely discontinued glucocorticoids. The Complete Remission rate in treatment-naïve patients (88.9%) was higher than in relapsed patients (73.3%), but the difference was not statistically significant. No independent predictors of RTX efficacy were identified, and no severe infections or allergic reactions were observed.
Conclusion: RTX equals glucocorticoids in podocytopathy, cuts steroid use and relapse, improves long-term kidney survival, and is safe. Treatment-naïve patients may choose RTX upfront to avoid steroid side effects; relapsed patients can taper and stop steroids. However, due to the limited sample size, these results should be interpreted with caution. Larger trials must confirm its long-term efficacy and ESRD protection.
Keywords: rituximab, minimal change disease, focal segmental glomerulosclerosis, therapeutic effects, nephrotic syndrome
Department of Nephrology, The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, 233004, People’s Republic of China
Correspondence: Yan Pan, Email py19841205@163.com Lei Liu, Email bbmcll@163.com
Background: Minimal Change Disease (MCD) / Focal Segmental Glomerulosclerosis (FSGS) are leading causes of adult nephrotic syndrome. Roughly half of patients need long-term immunosuppression for steroid dependence or relapse, but traditional drugs carry substantial adverse effects. Rituximab (RTX) depletes CD20⁺ B cells and reduces anti-podocyte antibodies; pediatric data are encouraging, yet direct adult evidence—especially between treatment-naïve and relapsed patients—remains scarce.
Methods: This study enrolled 82 patients with MCD/FSGS diagnosed between 2020 and 2023, divided into the RTX group (24 patients, 9 treatment-naïve and 15 relapsed) and the glucocorticoid group (58 patients). The RTX group received standard-dose RTX (375 mg/m2 weekly for 4 weeks), while the glucocorticoid group was treated with prednisone (1 mg/kg/day). Outcomes were compared using t-tests, χ2/Fisher, logistic regression, and Kaplan–Meier analyses.
Results: The overall remission rates were 100% in the RTX group and 98.3% in the glucocorticoid group (P=0.876), but the RTX group had a significantly higher eGFR at the last follow-up (124.25 vs 109.00 mL/min/1.73 m2, P=0.019). A statistically significant intergroup difference was also observed, with complete remission achieved in 89.5% of MCD patients versus 40% of FSGS patients (P< 0.05). In relapsed patients treated with RTX, prednisone dosage decreased from 34.0± 15.7 mg/day to 7.7± 7.8 mg/day (P< 0.001), annual relapse frequency dropped from 1.0 to 0 episodes/year (P=0.001), and 40% of patients completely discontinued glucocorticoids. The Complete Remission rate in treatment-naïve patients (88.9%) was higher than in relapsed patients (73.3%), but the difference was not statistically significant. No independent predictors of RTX efficacy were identified, and no severe infections or allergic reactions were observed.
Conclusion: RTX equals glucocorticoids in podocytopathy, cuts steroid use and relapse, improves long-term kidney survival, and is safe. Treatment-naïve patients may choose RTX upfront to avoid steroid side effects; relapsed patients can taper and stop steroids. However, due to the limited sample size, these results should be interpreted with caution. Larger trials must confirm its long-term efficacy and ESRD protection.
Keywords: rituximab, minimal change disease, focal segmental glomerulosclerosis, therapeutic effects, nephrotic syndrome