Comparison of the efficacy and impact on coagulation function of different rituximab dosage regimens in the treatment of membranous nephropathy.

OBJECTIVE

To compare the efficacy and safety of two rituximab (RTX) dosage regimens - 1 g and 375 mg/m - in patients with idiopathic membranous nephropathy (IMN), focusing on their effects on coagulation function.

METHODS

We conducted a single-center, retrospective cohort study involving 323 IMN patients treated at Baoji High-Tech Hospital between May 1, 2022, and February 28, 2024. Patients were categorized into a standard-dose group (375 mg/m, n=157) and a low-dose group (1 g, n=166) based on their RTX regimen. We compared clinical remission rates, relapse rates, adverse reactions, and changes in coagulation parameters (thrombin time [TT], prothrombin time [PT], fibrinogen [Fib]) between the groups.

RESULTS

Baseline characteristics, including age, gender, BMI, comorbidities, and immune indices, were similar between the groups (all P>0.05). Complete remission rates were 28.7% in the standard-dose group and 31.3% in the low-dose group, with overall response rates of 82.2% and 71.7%, respectively. Relapse rates were 19.1% and 19.3%, showing no significant differences (P>0.05). No significant differences in renal function, serum protein, urine protein, or PLA2R levels were observed between the groups (all P>0.05). Coagulation parameters remained unchanged before and after treatment (all P>0.05). Adverse reactions, including infections, infusion reactions, liver dysfunction, and gastrointestinal symptoms, occurred at similar rates in both groups (all P>0.05). Multivariate analysis identified BMI (OR=1.710, P<0.001), history of diabetes (OR=7.186, P=0.002), 24-hour urine protein at 6 months (OR=2.227, P<0.001), and PLA2R levels (OR=1.391, P<0.001) as independent risk factors for hypercoagulability.

CONCLUSION

Both 1 g and 375 mg/m RTX regimens exhibit comparable efficacy and safety in IMN patients, without significantly affecting coagulation function. Treatment should be individualized based on factors such as BMI, diabetes history, urine protein levels, and PLA2R levels to optimize coagulation risk management.