profiles of obinutuzumab and rituximab in the treatment of patients with primary membranous nephropathy (MN). Methods Patients with primary MN who had urine protein ≥3.5 g/24 hours and eGFR ≥30 ml/min per 1.73 m2 despite 6 months of angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker and treatment with obinutuzumab or rituximab were included and matched by propensity score (ratio: 1:2) on the basis of age, sex, urine protein, eGFR, and titers of Anti-Phospholipase A2 receptor (PLA2R) antibody. The primary outcome was defined as a combination of partial or complete remission at 12 months. Logistic regression models, Kaplan–Meier curves, and absolute risk differences were used to compare the therapeutic effectiveness and safety profiles of obinutuzumab and rituximab. Results Sixty-three patients with primary MN were included in the study, with 21 patients receiving obinutuzumab and 42 patients receiving rituximab. At 12 months, the primary outcome was achieved in 20 of 21 patients in the obinutuzumab group and 28 of 42 patients in the rituximab group (obinutuzumab versus rituximab: 95% versus 67%; odds ratio, 10.00; 95% confidence intervals, 1.21 to 82.35; P = 0.03). Moreover, patients in the obinutuzumab group acquired more complete remission (obinutuzumab versus rituximab: 38% versus 14%; odds ratio, 3.69; 95% confidence interval, 1.08 to 12.68; P = 0.04). In PLA2R-associated primary MN subgroup analyses, patients in the obinutuzumab group sustained lower CD19 B-cell counts (CD19 B-cell counts: median [interquartile range] 0 [0–6] cells/μl versus 20 [3–58] cells/μl, P = 0.002) and were more prone to achieve immunological remission (defined as PLA2R antibody <2 RU/ml) at 6 months (obinutuzumab versus rituximab: 92% [12 out of 13] versus 64% [16 out of 25], P = 0.06) than rituximab. Both treatment regimens were well tolerated. Conclusions Our study demonstrated that obinutuzumab is associated with higher odds of clinical remission compared with rituximab at 12 months, which may be due to higher immunological remission at 6 months with a similar safety profile in patients with primary MN....

中文翻译：

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Obinutuzumab 和利妥昔单抗治疗原发性膜性肾病的比较


obinutuzumab 和利妥昔单抗治疗原发性膜性肾病 （MN） 患者的概况。方法 纳入接受血管紧张素转换酶抑制剂/血管紧张素 II 受体阻滞剂治疗 6 个月并接受 obinutuzumab 或利妥昔单抗治疗后尿蛋白 ≥3.5 g/24 小时和 eGFR ≥30 ml/min /1.73 m2 的原发性 MN 患者，并根据年龄、性别、尿蛋白、eGFR 进行匹配。 以及抗磷脂酶 A2 受体 （PLA2R） 抗体的滴度。主要结局定义为 12 个月时部分或完全缓解的组合。使用 Logistic 回归模型、 Kaplan-Meier 曲线和绝对风险差异来比较 obinutuzumab 和利妥昔单抗的治疗效果和安全性。结果 纳入 63 例原发性 MN 患者，其中 21 例接受 obinutuzumab，42 例接受利妥昔单抗治疗。12 个月时，奥妥珠单抗组 21 例患者中有 20 例达到主要结局，利妥昔单抗组 42 例患者中有 28 例达到主要结局（奥妥珠单抗与利妥昔单抗：95% 对 67%;比值比，10.00;95% 置信区间，1.21 至 82.35;P = 0.03）。此外，奥妥珠单抗组患者获得了更完全的缓解（奥妥珠单抗与利妥昔单抗：38% 对 14%;比值比，3.69;95% 置信区间，1.08 至 12.68;P = 0.04）。在 PLA2R 相关的原发性 MN 亚组分析中，obinutuzumab 组患者的 CD19 B 细胞计数较低（CD19 B 细胞计数：中位 [四分位距] 0 [0-6] 个细胞/μl 与 20 个 [3-58] 个细胞/μl，P = 0。002），并且在 6 个月时更容易达到免疫缓解（定义为 PLA2R 抗体 <2 RU/ml）（obinutuzumab 与利妥昔单抗：92% [13 例中的 12 例] 对 64% [25 例中的 16 例]，P = 0.06）比利妥昔单抗。两种治疗方案的耐受性都很好。结论 我们的研究表明，与利妥昔单抗相比，obinutuzumab 在 12 个月时临床缓解的几率更高，这可能是由于 6 个月时免疫缓解较高，在原发性 MN 患者中具有相似的安全性。