Pub Date : 2024-09-12DOI: 10.2215/cjn.0000000000000557
Jung Nam An,Hyung Jung Oh,Sohee Oh,Harin Rhee,Eun Young Seong,Seon Ha Baek,Shin Young Ahn,Jang-Hee Cho,Jung Pyo Lee,Dong Ki Kim,Dong-Ryeol Ryu,Soyeon Ahn,Sejoong Kim
BACKGROUNDUltrafiltration with continuous kidney replacement therapy (CKRT) can be used to manage fluid balance in critically ill patients with acute kidney injury (AKI). We aimed to assess whether bioimpedance analysis (BIA)-guided volume management was more efficacious than conventional management for achieving estimated euvolemia (e-euvolemia) in CKRT-treated patients.METHODSIn a multi-center randomized controlled trial from July 2017 to July 2020, the patients with AKI requiring CKRT were eligible if the weight at the start of CKRT had increased by ≥5% compared to the weight at the time of admission, or total body water (TBW)/ height (H)2 ≥13 L/m2. We randomly assigned 208 patients to the control (conventional fluid management; N=103) and intervention groups (BIA-guided fluid management; N=105). Primary outcome was the proportion of attaining e-euvolemia seven days post-randomization. E-euvolemia was defined as the difference between TBW/H2 D7 and D0 was <-2.1 L/m2, or when TBW/H2 measured on D7 was <13 L/m2. The 28-, 60-, and 90-day mortality rate were secondary outcomes.RESULTSThe primary outcome occurred in 34 patients in the intervention group and 27 in the control group (47% versus 41%; P=0.50). The mean value of TBW/H2 measured on D7 was the same at 13.9 L/m2 in both groups. The differences between TBW/H2 D7 and D0 were -1.13 L/m2 in the intervention group and -1.08 L/m2 in the control group (P=0.84). Patients in the intervention group had a significantly higher proportion of reaching e-euvolemia on D1 than those in the control group (13% versus 4%, P=0.02). Adverse events did not differ significantly between the groups.CONCLUSIONSBIA-guided volume management did not affect the proportion of reaching the estimated euvolemia at seven days of the start of CKRT.TRIAL REGISTRATIONClinicalTrials.gov, ID: NCT03330626 (Registered on 6 November 2017; Seven study participants were retrospectively registered; nonetheless, IRB approval of each institution was completed before study participant registration).
{"title":"Bioimpedance-Guided Fluid Removal in Continuous Kidney Replacement Therapy: The VENUS Randomized Clinical Trial.","authors":"Jung Nam An,Hyung Jung Oh,Sohee Oh,Harin Rhee,Eun Young Seong,Seon Ha Baek,Shin Young Ahn,Jang-Hee Cho,Jung Pyo Lee,Dong Ki Kim,Dong-Ryeol Ryu,Soyeon Ahn,Sejoong Kim","doi":"10.2215/cjn.0000000000000557","DOIUrl":"https://doi.org/10.2215/cjn.0000000000000557","url":null,"abstract":"BACKGROUNDUltrafiltration with continuous kidney replacement therapy (CKRT) can be used to manage fluid balance in critically ill patients with acute kidney injury (AKI). We aimed to assess whether bioimpedance analysis (BIA)-guided volume management was more efficacious than conventional management for achieving estimated euvolemia (e-euvolemia) in CKRT-treated patients.METHODSIn a multi-center randomized controlled trial from July 2017 to July 2020, the patients with AKI requiring CKRT were eligible if the weight at the start of CKRT had increased by ≥5% compared to the weight at the time of admission, or total body water (TBW)/ height (H)2 ≥13 L/m2. We randomly assigned 208 patients to the control (conventional fluid management; N=103) and intervention groups (BIA-guided fluid management; N=105). Primary outcome was the proportion of attaining e-euvolemia seven days post-randomization. E-euvolemia was defined as the difference between TBW/H2 D7 and D0 was <-2.1 L/m2, or when TBW/H2 measured on D7 was <13 L/m2. The 28-, 60-, and 90-day mortality rate were secondary outcomes.RESULTSThe primary outcome occurred in 34 patients in the intervention group and 27 in the control group (47% versus 41%; P=0.50). The mean value of TBW/H2 measured on D7 was the same at 13.9 L/m2 in both groups. The differences between TBW/H2 D7 and D0 were -1.13 L/m2 in the intervention group and -1.08 L/m2 in the control group (P=0.84). Patients in the intervention group had a significantly higher proportion of reaching e-euvolemia on D1 than those in the control group (13% versus 4%, P=0.02). Adverse events did not differ significantly between the groups.CONCLUSIONSBIA-guided volume management did not affect the proportion of reaching the estimated euvolemia at seven days of the start of CKRT.TRIAL REGISTRATIONClinicalTrials.gov, ID: NCT03330626 (Registered on 6 November 2017; Seven study participants were retrospectively registered; nonetheless, IRB approval of each institution was completed before study participant registration).","PeriodicalId":50681,"journal":{"name":"Clinical Journal of the American Society of Nephrology","volume":null,"pages":null},"PeriodicalIF":9.8,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142231501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-12DOI: 10.2215/cjn.0000000000000530
Conrado Lysandro R Gomes,Thais Lyra Cleto-Yamane,Patricia da Silva Fucuta,Heitor Blesa Farias,Frederico Ruzany,José Hermógenes Rocco Suassuna
BACKGROUNDAcute kidney injury (AKI) is a complex syndrome typically classified into strict categories. Alternatively, it may be more accurate to consider it as an intermediate event between an initiating cause and its outcome. Therefore, we investigated the burden of clinical scenarios associated with dialysis-requiring AKI (AKI-D) using latent class analysis (LCA) and examined the etiological spectrum and clinical phenotypes across different life stages.METHODSWe analyzed 17,158 AKI-D patients from 170 medical facilities in Rio de Janeiro, Brazil (2002-2012). Utilizing survival curves and mixed-effects Cox regression for survival estimation, LCA classified patients based on clinical characteristics and outcomes, focusing on etiological variation over the human lifespan.RESULTSThe median age was 75 (IQR 59-83). Infections were the most common cause (44.2%), particularly community-acquired pneumonia (23.8%). Cardiovascular issues, especially ischemic heart disease (9.0%) and acute heart failure (8.1%), were also significant. LCA identified four distinct patient classes with varying clinical and outcome profiles. Class 1 patients were younger (median age 66), predominantly male, with lower ICU admission and higher rates of community-acquired AKI (60.8%). They had the lowest mortality (39.5%) and highest recovery rates. Class 2 had intermediate mortality (67.4%) and the highest comorbidity burden (mean Charlson score: 3.39). Classes 3 and 4 had the highest mortality (82.8% and 78.6%), requiring more mechanical ventilation and vasopressor use. Class 3 had a high prevalence of sepsis (92.7%) with lower comorbidities, while Class 4 had high chronic heart disease (76.3%) and perfusion factors (79.4%). Despite high mortality, Class 3 recovered better than Class 2 and 4. Survival analyses revealed diverse outcomes across etiological groups, with liver-related conditions being the most severe.CONCLUSIONSThis study highlights the complexity of AKI and the utility of LCA in revealing its clinical heterogeneity. It underscores distinct etiological trends across ages, suggesting future research should integrate clinical profiles with advanced diagnostics to understand AKI's clinical and molecular phenotypes throughout life.
背景急性肾损伤（AKI）是一种复杂的综合征，通常被严格分类。或者，将其视为起因和结果之间的中间事件可能更为准确。因此，我们使用潜类分析法（LCA）调查了与透析要求的 AKI（AKI-D）相关的临床情景的负担，并研究了不同生命阶段的病因谱和临床表型。结果中位年龄为 75 岁（IQR 59-83）。感染是最常见的病因（44.2%），尤其是社区获得性肺炎（23.8%）。心血管问题也很重要，尤其是缺血性心脏病（9.0%）和急性心力衰竭（8.1%）。LCA 确定了四类不同的病人，他们的临床和治疗结果各不相同。1 类患者更年轻（中位年龄为 66 岁），以男性为主，入住重症监护病房的比例较低，社区获得性 AKI 的比例较高（60.8%）。他们的死亡率最低（39.5%），康复率最高。2 级患者的死亡率居中（67.4%），合并症负担最重（平均 Charlson 评分：3.39）。3 级和 4 级的死亡率最高（分别为 82.8% 和 78.6%），需要更多的机械通气和血管加压。3 级患者脓毒症发病率高（92.7%），合并症较少，而 4 级患者慢性心脏病（76.3%）和灌注因素（79.4%）较多。尽管死亡率较高，但3级患者的恢复情况优于2级和4级。本研究强调了 AKI 的复杂性以及 LCA 在揭示其临床异质性方面的作用。结论：本研究强调了 AKI 的复杂性以及 LCA 在揭示其临床异质性方面的作用，并强调了不同年龄段的不同病因趋势，这表明未来的研究应将临床特征与先进的诊断技术相结合，以了解 AKI 在整个生命周期中的临床和分子表型。
{"title":"Phenotypes of Dialysis-Requiring Acute Kidney Injury and Associations with Mortality in a South American Population.","authors":"Conrado Lysandro R Gomes,Thais Lyra Cleto-Yamane,Patricia da Silva Fucuta,Heitor Blesa Farias,Frederico Ruzany,José Hermógenes Rocco Suassuna","doi":"10.2215/cjn.0000000000000530","DOIUrl":"https://doi.org/10.2215/cjn.0000000000000530","url":null,"abstract":"BACKGROUNDAcute kidney injury (AKI) is a complex syndrome typically classified into strict categories. Alternatively, it may be more accurate to consider it as an intermediate event between an initiating cause and its outcome. Therefore, we investigated the burden of clinical scenarios associated with dialysis-requiring AKI (AKI-D) using latent class analysis (LCA) and examined the etiological spectrum and clinical phenotypes across different life stages.METHODSWe analyzed 17,158 AKI-D patients from 170 medical facilities in Rio de Janeiro, Brazil (2002-2012). Utilizing survival curves and mixed-effects Cox regression for survival estimation, LCA classified patients based on clinical characteristics and outcomes, focusing on etiological variation over the human lifespan.RESULTSThe median age was 75 (IQR 59-83). Infections were the most common cause (44.2%), particularly community-acquired pneumonia (23.8%). Cardiovascular issues, especially ischemic heart disease (9.0%) and acute heart failure (8.1%), were also significant. LCA identified four distinct patient classes with varying clinical and outcome profiles. Class 1 patients were younger (median age 66), predominantly male, with lower ICU admission and higher rates of community-acquired AKI (60.8%). They had the lowest mortality (39.5%) and highest recovery rates. Class 2 had intermediate mortality (67.4%) and the highest comorbidity burden (mean Charlson score: 3.39). Classes 3 and 4 had the highest mortality (82.8% and 78.6%), requiring more mechanical ventilation and vasopressor use. Class 3 had a high prevalence of sepsis (92.7%) with lower comorbidities, while Class 4 had high chronic heart disease (76.3%) and perfusion factors (79.4%). Despite high mortality, Class 3 recovered better than Class 2 and 4. Survival analyses revealed diverse outcomes across etiological groups, with liver-related conditions being the most severe.CONCLUSIONSThis study highlights the complexity of AKI and the utility of LCA in revealing its clinical heterogeneity. It underscores distinct etiological trends across ages, suggesting future research should integrate clinical profiles with advanced diagnostics to understand AKI's clinical and molecular phenotypes throughout life.","PeriodicalId":50681,"journal":{"name":"Clinical Journal of the American Society of Nephrology","volume":null,"pages":null},"PeriodicalIF":9.8,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142231285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-11DOI: 10.2215/cjn.0000000000000528
Lama Ghazi, Vibhu Parcha, Tomonori Takeuchi, Catherine R Butler, Elizabeth Baker, Gabriela R Oates, Lucia D Juarez, Ariann F Nassel, AKM Fazlur Rahman, Edward D. Siew, Xinyuan Chen, Orlando M Gutierrez, Javier A Neyra
Pub Date : 2024-09-10DOI: 10.2215/cjn.0000000000000577
Orlando M Gutiérrez
{"title":"Symptom Burden and Altered Mineral Metabolism in Advanced Chronic Kidney Disease: Two Peas in a Pod.","authors":"Orlando M Gutiérrez","doi":"10.2215/cjn.0000000000000577","DOIUrl":"https://doi.org/10.2215/cjn.0000000000000577","url":null,"abstract":"","PeriodicalId":50681,"journal":{"name":"Clinical Journal of the American Society of Nephrology","volume":null,"pages":null},"PeriodicalIF":9.8,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142170561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-09DOI: 10.2215/cjn.0000000000000529
Amanda Sluiter,Rosanna Cazzolli,Allison Jaure,Nicole Scholes-Robertson,Jonathan C Craig,David W Johnson,Andrea Matus Gonzalez,Benedicte Sautenet,Ben J Smith,Karine Manera,
BACKGROUNDMany patients with chronic kidney disease (CKD) experience loneliness and social isolation, which are associated with a higher risk of mortality, morbidity, and poor mental health. We aimed to describe the perspectives of patients with CKD and their caregivers on loneliness and social isolation, to inform strategies to increase social participation.METHODSA secondary analysis of qualitative data from the Standardized Outcomes in Nephrology (SONG) initiative dataset (36 focus groups, three Delphi surveys and seven consensus workshops) was conducted. We extracted and thematically analyzed data from patients with CKD, including those receiving hemodialysis or peritoneal dialysis and those with a kidney transplant, as well as their caregivers, on the perspectives and experiences of loneliness and social isolation.RESULTSCollectively the studies included 1261 patients and caregivers from 25 countries. Six themes were identified: restricted by the burdens of disease and treatment (withdrawing from social activities due to fatigue, consumed by the dialysis regimen, tethered to treatment, travel restrictions); external vulnerability (infection risk, anxiety of dining out); diminishing societal role (grieving loss of opportunities, social consequences of inability to work); fending for oneself in healthcare (no one to relate to, lost in uncertainty, unmet psychosocial needs); undermining self-esteem (unable to engage in activities which previously defined self, shame and self-consciousness about appearance, hindering confidence for intimate relationships); and feeling ostracized (disconnected by family and friends, fear of stigma and being misunderstood, guilt of burdening others).CONCLUSIONSFor patients with CKD and their caregivers, social participation is substantially impaired by the burden of CKD and its treatment, and fear of risks to health such as infection. This undermines patient and caregiver mental health, particularly self-esteem and sense of belonging. Additional interventions are needed to improve social connections among people with CKD and their caregivers.
{"title":"Experiences of social isolation and loneliness in chronic kidney disease: a secondary qualitative analysis.","authors":"Amanda Sluiter,Rosanna Cazzolli,Allison Jaure,Nicole Scholes-Robertson,Jonathan C Craig,David W Johnson,Andrea Matus Gonzalez,Benedicte Sautenet,Ben J Smith,Karine Manera,","doi":"10.2215/cjn.0000000000000529","DOIUrl":"https://doi.org/10.2215/cjn.0000000000000529","url":null,"abstract":"BACKGROUNDMany patients with chronic kidney disease (CKD) experience loneliness and social isolation, which are associated with a higher risk of mortality, morbidity, and poor mental health. We aimed to describe the perspectives of patients with CKD and their caregivers on loneliness and social isolation, to inform strategies to increase social participation.METHODSA secondary analysis of qualitative data from the Standardized Outcomes in Nephrology (SONG) initiative dataset (36 focus groups, three Delphi surveys and seven consensus workshops) was conducted. We extracted and thematically analyzed data from patients with CKD, including those receiving hemodialysis or peritoneal dialysis and those with a kidney transplant, as well as their caregivers, on the perspectives and experiences of loneliness and social isolation.RESULTSCollectively the studies included 1261 patients and caregivers from 25 countries. Six themes were identified: restricted by the burdens of disease and treatment (withdrawing from social activities due to fatigue, consumed by the dialysis regimen, tethered to treatment, travel restrictions); external vulnerability (infection risk, anxiety of dining out); diminishing societal role (grieving loss of opportunities, social consequences of inability to work); fending for oneself in healthcare (no one to relate to, lost in uncertainty, unmet psychosocial needs); undermining self-esteem (unable to engage in activities which previously defined self, shame and self-consciousness about appearance, hindering confidence for intimate relationships); and feeling ostracized (disconnected by family and friends, fear of stigma and being misunderstood, guilt of burdening others).CONCLUSIONSFor patients with CKD and their caregivers, social participation is substantially impaired by the burden of CKD and its treatment, and fear of risks to health such as infection. This undermines patient and caregiver mental health, particularly self-esteem and sense of belonging. Additional interventions are needed to improve social connections among people with CKD and their caregivers.","PeriodicalId":50681,"journal":{"name":"Clinical Journal of the American Society of Nephrology","volume":null,"pages":null},"PeriodicalIF":9.8,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142165885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-06DOI: 10.2215/cjn.0000000000000562
Cheng-Wei Huang, Albert S. Yu, Hui Zhou, Katherine Pak, Sally F. Shaw, Jiaxiao Shi, Benjamin I. Broder, John J. Sim
An abstract is unavailable. This article is available as a PDF only.
无摘要。本文仅以 PDF 格式提供。
{"title":"Comparative Effectiveness of Bisoprolol, Carvedilol, and Metoprolol Succinate in Patients with Heart Failure and Chronic Kidney Disease","authors":"Cheng-Wei Huang, Albert S. Yu, Hui Zhou, Katherine Pak, Sally F. Shaw, Jiaxiao Shi, Benjamin I. Broder, John J. Sim","doi":"10.2215/cjn.0000000000000562","DOIUrl":"https://doi.org/10.2215/cjn.0000000000000562","url":null,"abstract":"An abstract is unavailable. This article is available as a PDF only.","PeriodicalId":50681,"journal":{"name":"Clinical Journal of the American Society of Nephrology","volume":null,"pages":null},"PeriodicalIF":9.8,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142170858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-09-04DOI: 10.2215/CJN.0000000000000572
Csaba P Kovesdy
{"title":"Intradialytic Hypotension in the Face of Using Different Antihypertensive Medication Classes.","authors":"Csaba P Kovesdy","doi":"10.2215/CJN.0000000000000572","DOIUrl":"https://doi.org/10.2215/CJN.0000000000000572","url":null,"abstract":"","PeriodicalId":50681,"journal":{"name":"Clinical Journal of the American Society of Nephrology","volume":null,"pages":null},"PeriodicalIF":8.5,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142127233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Despina Rüssmann, Prabir Roy-Chaudhury, Glenn M Chertow, Patrick Gee, Cynthia Chauhan, Steven Macari, Michael Murphy, Patrick Rossignol
{"title":"Where Are Patients' Voices in Chronic Kidney Disease?","authors":"Despina Rüssmann, Prabir Roy-Chaudhury, Glenn M Chertow, Patrick Gee, Cynthia Chauhan, Steven Macari, Michael Murphy, Patrick Rossignol","doi":"10.2215/CJN.0000000581","DOIUrl":"https://doi.org/10.2215/CJN.0000000581","url":null,"abstract":"","PeriodicalId":50681,"journal":{"name":"Clinical Journal of the American Society of Nephrology","volume":null,"pages":null},"PeriodicalIF":8.5,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142114427","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: This study compared the effectiveness and safety profiles of obinutuzumab and rituximab in the treatment of patients with primary membranous nephropathy.
Methods: Patients with primary membranous nephropathy who had urine protein ≥ 3.5 g/24 hours and estimated glomerular filtration 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.
简介本研究比较了奥比妥珠单抗和利妥昔单抗治疗原发性膜性肾病患者的有效性和安全性：方法：原发性膜性肾病患者，尿蛋白≥3.5 g/24 小时，估计肾小球滤过率（eGFR）≥30 mL/min/1.73 m2，且使用血管紧张素转换酶抑制剂/血管紧张素 II 受体阻滞剂和奥比妥珠单抗或利妥昔单抗治疗 6 个月的患者被纳入，并根据年龄、性别、尿蛋白、eGFR 和抗磷脂酶 A2 受体 (PLA2R) 抗体滴度进行倾向评分匹配（比例：1:2）。主要结果定义为 12 个月时部分或完全缓解的组合。采用逻辑回归模型、卡普兰-梅耶曲线和绝对风险差异比较了奥比妥珠单抗和利妥昔单抗的治疗效果和安全性：研究共纳入63名原发性膜性肾病患者，其中21名患者接受了奥比妥珠单抗治疗，42名患者接受了利妥昔单抗治疗。12个月后，奥比妥珠单抗组21名患者中有20名患者达到了主要治疗效果，利妥昔单抗组42名患者中有28名患者达到了主要治疗效果（奥比妥珠单抗与利妥昔单抗相比：95%对67%；几率）：95%对67%；几率比（OR）：10.00，95%置信区间（CI）：1.21-82.35，P=0.03）。此外，奥比妥珠单抗组患者获得的完全缓解率更高（奥比妥珠单抗 vs. 利妥昔单抗：38% vs. 14%; OR=0.03）：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，奥比妥珠单抗组患者的CD19 B细胞计数较低（CD19 B细胞计数：中位数（IQR）0（0-6）个/ul vs. 20（3-58）个/ul，P=0.002），更容易达到免疫学缓解（定义为PLA2R抗体结论）：我们的研究表明，与利妥昔单抗相比，奥比妥珠单抗在12个月时临床缓解的几率更高，这可能是由于原发性膜性肾病患者在6个月时免疫学缓解率更高，且安全性相似。
{"title":"Comparison of obinutuzumab and rituximab for treating primary membranous nephropathy.","authors":"Xiaofan Hu, Muyin Zhang, Jing Xu, Chenni Gao, Xialian Yu, Xiao Li, Hong Ren, Weiming Wang, Jingyuan Xie","doi":"10.2215/CJN.0000000000000555","DOIUrl":"https://doi.org/10.2215/CJN.0000000000000555","url":null,"abstract":"<p><strong>Introduction: </strong>This study compared the effectiveness and safety profiles of obinutuzumab and rituximab in the treatment of patients with primary membranous nephropathy.</p><p><strong>Methods: </strong>Patients with primary membranous nephropathy who had urine protein ≥ 3.5 g/24 hours and estimated glomerular filtration 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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":50681,"journal":{"name":"Clinical Journal of the American Society of Nephrology","volume":null,"pages":null},"PeriodicalIF":8.5,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142114426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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