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Efficacy and safety of obinutuzumab in refractory membranous nephropathy: a single-arm meta-analysis
Pengli Cong1, Jiayang Wang1, Xuanyi Du1
1Department of Nephrology, The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.
Objective:
Membranous nephropathy (MN) constitutes an autoimmune glomerular disorder and represents the most frequent etiology of primary nephrotic syndrome in adults. Although obinutuzumab exhibits favorable efficacy in managing refractory MN, outcomes diverge across individual investigations. Consequently, the present meta-analysis is undertaken to systematically evaluate the clinical efficacy and safety of obinutuzumab in individuals with refractory MN.
Methods:
A systematic search was conducted across the Cochrane Library, Embase, Web of Science, and PubMed to determine relevant clinical investigations published up to November 12, 2025. Treatment effects were quantified employing the pooled proportion rate with 95% confidence interval (CI), mean difference (MD, 95% CI), and standardized mean difference (SMD, 95% CI). Heterogeneity was examined via the I² statistic. Subgroup analyses were implemented based on the geographic distribution of the study population and duration of follow-up. All extracted data were subjected to statistical analysis using R (v4.5.2).
Results:
The present meta-analysis ultimately incorporated 12 articles (222 individuals) after applying the eligibility criteria. Concerning remission rates, the overall clinical remission rate reached 86% (95% CI: 80% to 90%), the complete clinical remission rate stood at 31% (25% to 37%), the partial clinical remission rate was 55% (49% to 63%), and the immunologic remission rate achieved 88% (81% to 92%). Obinutuzumab reduced proteinuria (SMD = -1.2, 95%CI -1.37 to -1.03) and raised serum albumin (MD = 12.5, 95%CI 9.91-15.08), while eGFR showed no significant change (MD = 3.23, 95%CI -3.76-10.21). The pooled adverse event rate was 29% (95%CI 15%-48%), with two fatal pneumonia-related events: severe COVID-19 pneumonia and pneumonia-induced respiratory failure.
Conclusion:
Obinutuzumab demonstrates marked efficacy in treating refractory MN, with an overall clinical remission rate of 86% and a low incidence of severe adverse events. This profile signifies a potential therapeutic role for this condition. However, all raw data included in this meta-analysis were derived from uncontrolled retrospective single-arm trials and case series. Given factors such as selection bias, the remission rate may be overestimated. Large-scale, multicenter randomized controlled trials are necessary for verification in future investigations.
Systematic Review Registration:
https://www.crd.york.ac.uk/PROSPERO/, identifier CRD420251231344.
Insights
Obinutuzumab shows 86% clinical remission in refractory membranous nephropathy (MN). This meta-analysis highlights its efficacy but calls for randomized trials due to potential bias in current data.
Area of Science:
- Nephrology
- Immunology
- Pharmacology
Background:
- Membranous nephropathy (MN) is an autoimmune glomerular disorder and a leading cause of adult nephrotic syndrome.
- Obinutuzumab shows promise for refractory MN, but individual study outcomes vary.
Purpose of the Study:
- To systematically evaluate the clinical efficacy and safety of obinutuzumab in patients with refractory MN through a meta-analysis.
Main Methods:
- A systematic literature search was performed across major databases up to November 2025.
- Treatment effects were quantified using pooled proportions and measures of central tendency with confidence intervals.
- Heterogeneity and subgroup analyses were conducted, with data analyzed using R (v4.5.2).
Main Results:
- The meta-analysis included 12 articles with 222 patients.
- Overall clinical remission was 86%, with complete remission at 31% and partial at 55%. Immunologic remission was 88%.
- Obinutuzumab reduced proteinuria and increased serum albumin, with no significant change in eGFR. Adverse events occurred in 29% of patients.
Conclusions:
- Obinutuzumab demonstrates significant efficacy in treating refractory MN with a favorable safety profile.
- The current data, derived from uncontrolled studies, may overestimate remission rates.
- Further large-scale, multicenter randomized controlled trials are essential to validate these findings.