RETROSPECTIVE ANALYSIS OF RITUXIMAB EFFICACY AND SAFETY IN CHINESE PATIENTS WITH PODOCYTOPATHIES

Podocytopathies are common pathological subtypes of nephrotic syndrome, encompassing minimal change disease (MCD) and focal segmental glomerulosclerosis (FSGS). Patients with primary podocytopathies frequently experience relapses, glucocorticoid dependence or resistance, complicating disease management, thus underscoring the need for novel alternatives in refractory cases. These disorders are largely immune-mediated and usually show some responsiveness to immunosuppressors. Rituximab (RTX), a monoclonal antibody targeting CD 20, is increasingly being employed in the treatment of refractory podocytopathies. However, high-quality evidence supporting its efficacy in adults remains scarce, with most data derived from small observational studies or case reports. The present real-world study aims to evaluate the efficacy and safety of RTX in Chinese patients with podocytopathies.

This single-center retrospective study included rituximab-treated patients with primary podocytopathies from our hospital between 2017 and 2025. Eligible patients had received at least one course of RTX and had a minimum clinical follow-up of 12 months. Individuals with secondary glomerular diseases were excluded. The use and choice of maintenance therapy was left to the treating physician’s discretion. The primary outcome was initial response at 6 months and relapse-free survival rate at 12 months. Secondary analyses included renal function, use of immunosuppressants, and adverse events.

We administered RTX-based induction to 109 patients with refractory nephrotic syndrome (24 FSGS, 85 MCD): 86.1% were steroid-dependent/frequently relapsing and 81.7% had failed ≥2 prior immunosuppressive lines. Of the cohort, males comprised 71.6% and median age was 19.0 [15.0, 27.0] years. RTX dosing protocol was individualized: 47.7% received 375 mg/m² intravenously once weekly for four weeks, and 11% two 1g infusions with a two-week interval. At baseline, 15.6% of patients had a history of acute kidney injury, proteinuria was 3.91 [0.90, 9.35] g/24 h, and median follow-up period was 840 days. Within six months of first infusion, the complete response (CR) rate was 59.6%, and the partial response (PR) 29.4%, yielding an overall response of 89.0%. Figure 1 presents Kaplan–Meier estimates of relapse-free survival in all initial RTX responders, with no significant difference found between the maintenance (red line) subgroup with no-maintenance (blue line) subgroup (p = 0.11). At 12 months, relapse had occurred in 10% of the overall cohort. Over the follow-up period, eGFR remained stable in all the patients (Figure 2). Approximately 9.2% of patients experienced adverse events during or after rituximab therapy

In conclusion, RTX induced high initial remission and sustained relapse-free survival in patients with podocytopathies, while minimizing concomitant immunosuppression. Collectively, our findings support the use of RTX as an effective steroid-sparing remission strategy. Large-scale, multicenter, randomized controlled trials with prolonged follow-up are warranted to confirm these benefits and to establish the optimal induction and maintenance RTX regimens.