tration rate (eGFR) ≥30 mL/min/1.73 m2 despite six 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) based on 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 employed to compare the therapeutic effectiveness and safety profiles of obinutuzumab and rituximab. Results: Sixty-three patients with primary membranous nephropathy 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 vs. rituximab: 95% vs. 67%; odds ratio (OR): 10.00, 95% confidence intervals (CI):1.21-82.35, P=0.03). Moreover, patients in the obinutuzumab group acquired more complete remission (obinutuzumab vs. rituximab: 38% vs. 14%; OR: 3.69, 95% CI:1.08-12.68, P=0.04). In PLA2R-associated primary membranous nephropathy subgroup analyses, patients in obinutuzumab group sustained lower CD19 B cell counts (CD19 B cell counts: median (IQR) 0 (0-6) cells/ul vs. 20 (3-58) cells/ul, P=0.002) and were more prone to achieve immunological remission (defined as PLA2R antibody <2 RU/ml) at six months [obinutuzumab vs. rituximab: 92% (12 out of 13) vs. 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 to rituximab at 12 months which may be due to higher immunological remission at six months with a similar safety profile in patients with primary membranous nephropathy. Copyright © 2024 by the American Society of Nephrology...

中文翻译：

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奥比妥珠单抗与利妥昔单抗治疗原发性膜性肾病的比较


尽管接受了六个月的血管紧张素转换酶抑制剂/血管紧张素 II 受体阻滞剂以及 obinutuzumab 或利妥昔单抗治疗，但治疗率 (eGFR) ≥30 mL/min/1.73 m2 也被包括在内，并通过基于年龄的倾向评分（比例：1:2）进行匹配、性别、尿蛋白、eGFR 和抗磷脂酶 A2 受体 (PLA2R) 抗体滴度。主要结局定义为 12 个月时部分或完全缓解的组合。采用逻辑回归模型、Kaplan Meier 曲线和绝对风险差异来比较 obinutuzumab 和利妥昔单抗的治疗有效性和安全性。结果：该研究纳入了 63 名原发性膜性肾病患者，其中 21 名患者接受奥比妥珠单抗治疗，42 名患者接受利妥昔单抗治疗。 12 个月时，obinutuzumab 组 21 名患者中的 20 名和利妥昔单抗组 42 名患者中的 28 名达到主要结局（obinutuzumab 与利妥昔单抗：95% vs. 67%；比值比 (OR)：10.00, 95%置信区间（CI）：1.21-82.35，P=0.03）。此外，obinutuzumab 组的患者获得了更完全的缓解（obinutuzumab 与利妥昔单抗：38% vs. 14%；OR：3.69，95% CI：1.08-12.68，P=0.04）。在 PLA2R 相关原发性膜性肾病亚组分析中，obinutuzumab 组患者的 CD19 B 细胞计数持续较低（CD19 B 细胞计数：中位数 (IQR) 0 (0-6) 个细胞/ul vs. 20 (3-58) 个细胞/ul ，P=0.002）并且更容易在六个月时实现免疫缓解（定义为 PLA2R 抗体 <2 RU/ml）[obinutuzumab 与利妥昔单抗：92%（13 人中的 12 人）对比 64%（25 人中的 16 人） ），P=0.06] 优于利妥昔单抗。两种治疗方案均具有良好的耐受性。 结论：我们的研究表明，与 12 个月时的利妥昔单抗相比，obinutuzumab 与更高的临床缓解几率相关，这可能是由于原发性膜性肾病患者在 6 个月时的免疫学缓解率更高，且安全性相似。版权所有 © 2024 美国肾脏病学会...