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利妥昔单抗在视神经脊髓炎谱系障碍中不同初始剂量和维持剂量的疗效:来自墨西哥一家国立卫生机构的经验。

Rituximab efficacy at different initial and maintenance doses in neuromyelitis optica spectrum disorder: Experience from a national health institute in México.

作者信息

Casallas-Vanegas Adriana, Gomez-Figueroa Enrique, de Saráchaga Adib Jorge, Zabala-Angeles Indhira, García-Estrada Christian, Salado-Burbano Jorge C, DiazGranados-Palacio María Clara, Corona-Vázquez Teresita, de Jesús Flores-Rivera José, Rivas-Alonso Verónica

机构信息

Instituto Nacional de Neurología y Neurocirugía, Mexico City, Mexico.

The American British Cowdray Medical Center, Mexico City, Mexico.

出版信息

J Neurol Sci. 2020 Dec 15;419:117204. doi: 10.1016/j.jns.2020.117204. Epub 2020 Oct 22.

Abstract

BACKGROUND

NMOSD is an inflammatory disorder of the central nervous system that primarily affects the optic nerves and spinal cord. Rituximab (RTX) is a monoclonal antibody directed against CD20, an epitope expressed on pre-B and mature B cells. It has of wide use in several antibody-mediated autoimmune diseases.

OBJECTIVES

To demonstrate RTX clinical efficacy at different initial and maintenance doses administered in patients with NMOSD.

METHODS

In this retrospective/observational study we recruited subjects with NMOSD with at least one RTX infusion. Annual relapse rates (ARR) were compared in several induction and maintenance regimens with RTX in 66 patients with NMOSD.

RESULTS

Fifty-four (81.8%) were female and two thirds (66.7%) had positive anti-AQP4 antibodies. The most prevalent induction and maintenance regimens were 1000 mg on days 1 and 15 (51.5%) and 1000 mg every 6 months (40.9%), respectively. Overall, the annual relapse rate (ARR) decreased from 1.15 to 0.46 with RTX (p < 0.001). In patients with persistent relapses, the ARR decreased from 1.66 to 1.22, representing a relative risk reduction of 24%. Treatment with RTX decreased the ARR from 1.36 to 0.4 in the 500 mg induction and maintenance dose subgroup, and from 0.7 to 0.4 in the 1000 mg induction and maintenance dose subgroup.

CONCLUSION

RTX treatment in patients with NMOSD demonstrated a marked and sustained reduction in the ARR, regardless of induction and maintenance regimens. EDSS stability was observed, even in patients with active and severe NMOSD.

摘要

背景

视神经脊髓炎谱系疾病(NMOSD)是一种主要影响视神经和脊髓的中枢神经系统炎性疾病。利妥昔单抗(RTX)是一种针对CD20的单克隆抗体,CD20是在前B细胞和成熟B细胞上表达的一个表位。它在几种抗体介导的自身免疫性疾病中广泛应用。

目的

证明RTX在不同初始剂量和维持剂量下治疗NMOSD患者的临床疗效。

方法

在这项回顾性/观察性研究中,我们招募了至少接受过一次RTX输注的NMOSD患者。比较了66例NMOSD患者使用RTX的几种诱导和维持方案的年复发率(ARR)。

结果

54例(81.8%)为女性,三分之二(66.7%)抗水通道蛋白4抗体呈阳性。最常见的诱导和维持方案分别是第1天和第15天使用1000mg(51.5%)以及每6个月使用1000mg(40.9%)。总体而言,使用RTX后年复发率(ARR)从1.15降至0.46(p<0.001)。在持续复发的患者中,ARR从1.66降至1.22,相对风险降低24%。在500mg诱导和维持剂量亚组中,RTX治疗使ARR从1.36降至0.4,在1000mg诱导和维持剂量亚组中,ARR从0.7降至0.4。

结论

NMOSD患者使用RTX治疗显示年复发率显著且持续降低,无论诱导和维持方案如何。即使在患有活动性和重度NMOSD的患者中也观察到了扩展残疾状态量表(EDSS)的稳定性。

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