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利妥昔单抗持续清除 CD-19 可有效维持钙调磷酸酶抑制剂依赖的足细胞病缓解。

Persistent CD-19 depletion by rituximab is cost-effective in maintaining remission in calcineurin-inhibitor dependent podocytopathy.

机构信息

Department of Nephrology, PGIMER, Chandigarh, India.

Department of Nephrology, KMC, Manipal, India.

出版信息

Nephrology (Carlton). 2019 Dec;24(12):1241-1247. doi: 10.1111/nep.13554. Epub 2019 May 1.

Abstract

AIM

A significant proportion of patients with minimal change disease (MCD) and focal segmental glomerulosclerosis (FSGS) are either steroid dependent or steroid resistant, requiring long-term calcineurin inhibitors (CNI) use. Rituximab has more favourable safety profile. The present study was undertaken to evaluate the efficacy and safety of rituximab in CNI-dependent patients.

METHODS

This was a prospective observational study conducted from July 2014 to February 2018. Steroid-dependent nephrotic syndrome or steroid-resistant nephrotic syndrome (biopsy proven MCD/FSGS), who were CNI dependent were enrolled. Mean age at enrolment was 22.77 ± 7.45 years. All patients received rituximab at a dose of 375 mg/m at entry in the study. CD-19 levels were monitored monthly and patients having CD-19 levels >5/μL and/or > 1% received additional low-dose (100 mg) of rituximab.

RESULTS

A total of 24 patients were followed up for 12 months. At the end of 6 and 12 months, 87.5% and 79.16% of the patients achieved remission, respectively. Eight (33.33%) patients developed relapse. The mean dose of rituximab in the first year was 791 mg. The average cost of rituximab in the first year was 487.17$. Rituximab was well-tolerated, with mild infusion reactions, respiratory tract infection and oral candidiasis in 5 (20.83%), 5 (20.83%) and 1 (4.17%) patient, respectively.

CONCLUSIONS

CD-19 targeted rituximab is a safe and cost-effective agent in remission maintenance in adults with CNI dependent. Over three-fourths of the patients with CNI-dependent podocytopathy maintain clinical remission with CD-19 targeted rituximab therapy.

摘要

目的

相当一部分微小病变性肾病(MCD)和局灶节段性肾小球硬化症(FSGS)患者对类固醇治疗依赖或抵抗,需要长期使用钙调磷酸酶抑制剂(CNI)。利妥昔单抗具有更好的安全性。本研究旨在评估利妥昔单抗在 CNI 依赖患者中的疗效和安全性。

方法

这是一项从 2014 年 7 月至 2018 年 2 月进行的前瞻性观察性研究。纳入了对类固醇治疗依赖的肾病综合征或类固醇抵抗的肾病综合征(活检证实为 MCD/FSGS)的患者。入组时的平均年龄为 22.77±7.45 岁。所有患者在入组时均接受了 375mg/m 的利妥昔单抗治疗。每月监测 CD-19 水平,当患者的 CD-19 水平>5/μL 和/或>1%时,给予额外的低剂量(100mg)利妥昔单抗。

结果

共有 24 例患者接受了为期 12 个月的随访。在第 6 个月和第 12 个月时,分别有 87.5%和 79.16%的患者达到缓解。8 例(33.33%)患者复发。第一年的平均利妥昔单抗剂量为 791mg。第一年的利妥昔单抗平均费用为 487.17 美元。利妥昔单抗耐受性良好,5 例(20.83%)患者出现轻度输液反应,5 例(20.83%)患者出现呼吸道感染,1 例(4.17%)患者出现口腔念珠菌病。

结论

针对 CD-19 的利妥昔单抗是一种安全且具有成本效益的药物,可用于维持 CNI 依赖的成年人的缓解。超过四分之三的 CNI 依赖足细胞病患者用 CD-19 靶向利妥昔单抗治疗可维持临床缓解。

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