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已发表论文
针对抗PLA2R血清学与组织学均阴性的原发性膜性肾病：靶向CD20治疗中奥滨尤妥珠单抗是否优于利妥昔单抗？
Authors Cao H, Feng Y, Li X, Ke B , Gong L
Received 14 August 2025
Accepted for publication 25 October 2025
Published 7 November 2025 Volume 2025:19 Pages 9983—9992
DOI https://doi.org/10.2147/DDDT.S560746
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Solomon Tadesse Zeleke
Huiling Cao,1,* Yumei Feng,2,* Xueting Li,1 Ben Ke,1 Limin Gong3
1Department of Nephrology, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, People’s Republic of China; 2Department of Emergency, Pingxiang People’s Hospital, Pingxiang, Jiangxi, 337055, People’s Republic of China; 3Department of General Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Ben Ke, Department of Nephrology, The Second Affiliated Hospital of Nanchang University, No. 1 Minde Road, Nanchang, Jiangxi, 330006, People’s Republic of China, Tel +8615270882765, Email keben-1989125@163.com Limin Gong, Department of General Medicine, The Second Affiliated Hospital of Nanchang University, No. 1 Minde Road, Nanchang, Jiangxi, 330006, People’s Republic of China, Tel +8613907099310, Email 1419424379@qq.com
Background: Anti-CD20 monoclonal antibody has become the first-line treatment option for primary membranous nephropathy (PMN), regardless of PLA2R status. Obinutuzumab (OBZ), a humanized anti-CD20 monoclonal antibody, has shown higher remission rates with an acceptable safety profile over rituximab (RTX), whether in the initial treatment or refractory PLA2R-associated membranous nephropathy. However, the efficacy evaluation of the OBZ and RTX in PLA2R-negative PMN has not been reported yet.
Methods: 39 patients with PMN who were negative for serum anti-PLA2R antibodies and showed negative PLA2R staining in renal biopsy were retrospectively included in this study, with 18 receiving OBZ and 21 receiving RTX. All patients received a 12-month follow-up. The primary outcome was the rate of patients achieving complete or partial remission (CR or PR) at 12 months. Secondary outcomes included changes in laboratory parameters, relapse, and adverse events.
Results: At 12 months, CR or PR was achieved in 17 of 18 (94.4%) patients in the OBZ group and 18 of 21 (85.7%) patients in the RTX group, with the difference between the two groups not being statistically significant (OR=2.83, 95% CI: 0.27– 29.96; p=0.61). Kaplan-Meier analyses showed that the cumulative CR or PR rates were not significantly different (Log-Rank p=0.68). Adverse events occurred in 4 cases (22.2%) in the OBZ group and 6 cases (28.6%) in the RTX group. During the 12-momth follow-up, no relapse was observed in the OBZ group, whereas post remission relapse occurred in 2 (9.5%) of 21 patients in the RTX group (p=0.49).
Conclusion: In patients with PLA2R-negative PMN, OBZ demonstrated similar efficacy to RTX, and both had a favorable safety profile.
Keywords: primary membranous nephropathy, rituximab, obinutuzumab, M-type phospholipase A2 receptor, anti-CD20 monoclonal antibody
1Department of Nephrology, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, People’s Republic of China; 2Department of Emergency, Pingxiang People’s Hospital, Pingxiang, Jiangxi, 337055, People’s Republic of China; 3Department of General Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Ben Ke, Department of Nephrology, The Second Affiliated Hospital of Nanchang University, No. 1 Minde Road, Nanchang, Jiangxi, 330006, People’s Republic of China, Tel +8615270882765, Email keben-1989125@163.com Limin Gong, Department of General Medicine, The Second Affiliated Hospital of Nanchang University, No. 1 Minde Road, Nanchang, Jiangxi, 330006, People’s Republic of China, Tel +8613907099310, Email 1419424379@qq.com
Background: Anti-CD20 monoclonal antibody has become the first-line treatment option for primary membranous nephropathy (PMN), regardless of PLA2R status. Obinutuzumab (OBZ), a humanized anti-CD20 monoclonal antibody, has shown higher remission rates with an acceptable safety profile over rituximab (RTX), whether in the initial treatment or refractory PLA2R-associated membranous nephropathy. However, the efficacy evaluation of the OBZ and RTX in PLA2R-negative PMN has not been reported yet.
Methods: 39 patients with PMN who were negative for serum anti-PLA2R antibodies and showed negative PLA2R staining in renal biopsy were retrospectively included in this study, with 18 receiving OBZ and 21 receiving RTX. All patients received a 12-month follow-up. The primary outcome was the rate of patients achieving complete or partial remission (CR or PR) at 12 months. Secondary outcomes included changes in laboratory parameters, relapse, and adverse events.
Results: At 12 months, CR or PR was achieved in 17 of 18 (94.4%) patients in the OBZ group and 18 of 21 (85.7%) patients in the RTX group, with the difference between the two groups not being statistically significant (OR=2.83, 95% CI: 0.27– 29.96; p=0.61). Kaplan-Meier analyses showed that the cumulative CR or PR rates were not significantly different (Log-Rank p=0.68). Adverse events occurred in 4 cases (22.2%) in the OBZ group and 6 cases (28.6%) in the RTX group. During the 12-momth follow-up, no relapse was observed in the OBZ group, whereas post remission relapse occurred in 2 (9.5%) of 21 patients in the RTX group (p=0.49).
Conclusion: In patients with PLA2R-negative PMN, OBZ demonstrated similar efficacy to RTX, and both had a favorable safety profile.
Keywords: primary membranous nephropathy, rituximab, obinutuzumab, M-type phospholipase A2 receptor, anti-CD20 monoclonal antibody