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利妥昔单抗治疗系统性红斑狼疮的有效性和安全性:描述 2 个中心经验的病例系列

Effectiveness and Safety of Rituximab in Systemic Lupus Erythematosus: A Case Series Describing the Experience of 2 Centers.

机构信息

Universitat Pompeu Fabra, Universitat Autònoma de Barcelona, Barcelona, España.

Servicio de Reumatología, Hospital del Mar/Parc de Salut-Mar/IMIM, Barcelona, España.

出版信息

Reumatol Clin (Engl Ed). 2020 Sep-Oct;16(5 Pt 2):391-395. doi: 10.1016/j.reuma.2018.08.012. Epub 2018 Dec 3.

DOI:10.1016/j.reuma.2018.08.012
PMID:30522941
Abstract

BACKGROUND

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that affects multiple organs and systems. B cells have a critical role in the pathogenesis of SLE. Rituximab (RTX) is a drug composed of chimeric monoclonal antibodies against the CD20 protein, producing a depletion of B lymphocytes.

OBJECTIVE

To analyze the effectiveness and safety of RTX in patients with SLE in clinical practice.

METHODS

Collection of retrospective variables of the medical records of 20 patients with SLE treated with RTX in 2hospitals (Hospital de la Santa Creu i Sant Pau, and Hospital del Mar, in Barcelona, Spain). We evaluated demographic, clinical, serological and treatment variables.

RESULTS

There was a statistically significant association in the following variables collected in the study before and after treatment: there was a decrease in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) (P<.001), erythrocyte sedimentation rate (P=.017), use of glucocorticoids (P=.025) and IgM values (P=.031), as well as an increase in the C4 values (P=.014) after treatment with RTX. A patient with SLE, antiphospholipid syndrome, complex comorbidity and multiorgan lupus involvement died after developing a septic process, months after receiving a single treatment cycle with RTX.

CONCLUSIONS

Although RTX currently has no official indication approved for SLE, our data suggest that it may be effective in reducing the activity of the disease and as a steroid-sparing agent, with an acceptable safety profile. However, larger follow-up periods with a greater number of patients are needed to solve the remaining doubts about the use of RTX in SLE.

摘要

背景

系统性红斑狼疮(SLE)是一种影响多个器官和系统的慢性自身免疫性疾病。B 细胞在 SLE 的发病机制中起着关键作用。利妥昔单抗(RTX)是一种由针对 CD20 蛋白的嵌合单克隆抗体组成的药物,可导致 B 淋巴细胞耗竭。

目的

分析 RTX 在临床实践中治疗 SLE 患者的有效性和安全性。

方法

收集西班牙巴塞罗那两家医院(圣十字圣保罗医院和圣玛丽医院)20 例 SLE 患者接受 RTX 治疗的病历回顾性变量。我们评估了人口统计学、临床、血清学和治疗变量。

结果

在治疗前后收集的研究变量中存在统计学显著关联:系统性红斑狼疮疾病活动指数(SLEDAI)(P<.001)、红细胞沉降率(P=.017)、糖皮质激素(P=.025)和 IgM 值(P=.031)的使用减少,以及 C4 值(P=.014)在接受 RTX 治疗后增加。一名患有 SLE、抗磷脂综合征、复杂合并症和多器官狼疮受累的患者在接受单次 RTX 治疗周期后数月因发生脓毒症而死亡。

结论

尽管 RTX 目前尚未获得 SLE 的官方批准适应症,但我们的数据表明,它可能有效降低疾病活动度,并作为类固醇节约剂,具有可接受的安全性。然而,需要进行更长时间的随访并增加患者数量,以解决关于在 SLE 中使用 RTX 的剩余疑问。

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