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实现当前免疫抑制治疗方案的 EULAR/ERA-EDTA 治疗目标以及治疗调整:一项多中心、真实世界观察性研究。

Attainment of EULAR/ERA-EDTA targets of therapy with current immunosuppressive regimens and adjustments in treatment: a multicentre, real-life observational study.

机构信息

National and Kapodistrian University of Athens, School of Medicine, Rheumatology Unit, First Department of Propaedeutic Internal Medicine, Athens, Greece.

National and Kapodistrian University of Athens, "Attikon" University Hospital, Rheumatology Unit, Fourth Department of Internal Medicine, Athens, Greece.

出版信息

RMD Open. 2024 Sep 18;10(3):e004437. doi: 10.1136/rmdopen-2024-004437.

DOI:10.1136/rmdopen-2024-004437
PMID:39299738
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11429000/
Abstract

OBJECTIVE

To estimate real-life European Alliance of Associations for Rheumatology (EULAR)/European Renal Association (ERA)-European Dialysis and Transplantation Association (EDTA) response rates and predictors for no response in patients with lupus nephritis (LN) managed with conventional immunosuppressive therapies.

METHODS

Ambidirectional cohort study of patients with new-onset LN (period 2014-to date). Response rates in the first year were calculated, and all treatment modifications were recorded. Univariate and multivariate regression analyses were performed to assess determinants of failure to respond at 12 months.

RESULTS

140 patients were included (81.4% women, median (IQR) age at LN diagnosis 38 (22) years). Among them, 32.1% presented with nephrotic range proteinuria, 28.6% with glomerular filtration rate <60 mL/min, 76.6% had proliferative and 19.7% class V LN. Initial treatment consisted of cyclophosphamide in 51.4% of patients (84.7% high-dose, 15.3% low-dose) and mycophenolate in 32.1%. 120 patients had available data at 12 months. EULAR/ERA-EDTA renal response rates at 3, 6 and 12 months were achieved by 72.6%, 78.5% % and 69.2% of patients, respectively. In multivariate analysis, increased Chronicity Index at baseline was associated with failure to achieve either complete or partial response at 12 months (OR 2.26, 95% CI 1.35 to 3.77). Notably, 20% of patients required treatment modifications due to suboptimal response during the first 12 months, with the addition of or switch to a different immunosuppressive drug in seven and nine patients, respectively.

CONCLUSIONS

More than two-thirds of patients with LN attain EULAR/ERA-EDTA response rates by 12 months, but 20% require therapy modifications within this time period. Patients with increased chronicity in baseline biopsy, when combined with histological activity, are at higher risk for a lack of clinical response.

摘要

目的

评估接受传统免疫抑制治疗的狼疮肾炎(LN)患者的欧洲抗风湿病联盟(EULAR)/欧洲肾脏协会(ERA)-欧洲透析和移植协会(EDTA)真实世界缓解率和无缓解预测因子。

方法

对新诊断为 LN 的患者进行双向队列研究(2014 年至今)。计算第一年的缓解率,并记录所有治疗调整。进行单变量和多变量回归分析,以评估 12 个月时无反应的决定因素。

结果

共纳入 140 例患者(81.4%为女性,LN 诊断时的中位(IQR)年龄为 38(22)岁)。其中,32.1%患者出现肾病范围蛋白尿,28.6%患者肾小球滤过率<60ml/min,76.6%患者为增生性 LN,19.7%患者为 V 型 LN。初始治疗中,51.4%的患者接受环磷酰胺治疗(84.7%为大剂量,15.3%为低剂量),32.1%的患者接受霉酚酸酯治疗。120 例患者在 12 个月时有可用数据。3、6 和 12 个月时,EULAR/ERA-EDTA 肾脏缓解率分别为 72.6%、78.5%和 69.2%。多变量分析显示,基线时慢性指数增加与 12 个月时未能完全或部分缓解相关(OR 2.26,95%CI 1.35-3.77)。值得注意的是,20%的患者由于前 12 个月的疗效不佳而需要治疗调整,分别有 7 例和 9 例患者添加或转换为不同的免疫抑制剂药物。

结论

超过三分之二的 LN 患者在 12 个月时达到 EULAR/ERA-EDTA 缓解率,但在此期间有 20%的患者需要调整治疗方案。基线活检中慢性程度增加的患者,结合组织学活动,发生临床无反应的风险更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/324c/11429000/57036b4c9211/rmdopen-10-3-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/324c/11429000/d1a0f5dc6401/rmdopen-10-3-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/324c/11429000/b29415fe8e7c/rmdopen-10-3-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/324c/11429000/57036b4c9211/rmdopen-10-3-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/324c/11429000/d1a0f5dc6401/rmdopen-10-3-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/324c/11429000/b29415fe8e7c/rmdopen-10-3-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/324c/11429000/57036b4c9211/rmdopen-10-3-g003.jpg

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