利妥昔单抗对厄瓜多尔视神经脊髓炎谱系疾病患者复发率和残疾的影响。
Impact of Rituximab on relapse rate and disability in an Ecuadorian cohort of patients with neuromyelitis optica spectrum disorders.
机构信息
Department of Neurology. Hospital Carlos Andrade Marín. Quito, Universidad Central del Ecuador, Quito.
Department of Neurology, Hospital Carlos Andrade Marín, Quito.
出版信息
Mult Scler Relat Disord. 2021 Feb;48:102683. doi: 10.1016/j.msard.2020.102683. Epub 2020 Dec 9.
BACKGROUND
Neuromyelitis Optica Spectrum Disorder (NMOSD) is a severe inflammatory demyelinating disease of the central nervous system that often causes disability. Based on evidence from prospective and retrospective studies, Rituximab (RTX) has been used as the first-line of therapy in NMOSD. Nevertheless, evidence of the impact of RTX on relapse rate and disability in Ecuadorian patients with NMOSD is lacking.
OBJECTIVE
To evaluate the impact of RTX in an Ecuadorian cohort of patients with NMOSD.
MATERIALS AND METHODS
A retrospective study was conducted in a cohort of patients with NMOSD who received treatment with RTX in a third-level hospital in Quito, Ecuador. Digital medical records of NMOSD patients were reviewed to attain sociodemographic data, disease characteristics, and treatment with RTX. The annualized relapse rate ARR, as well as the degree of disability measured through the expanded disability scale (EDSS), was established before and after treatment.
RESULTS
Twenty-three patients with NMOSD treated with RTX were included, the mean age of onset of the disease was 37.2 years (range, 13-64.5). The average duration of disease was 8.5 years (range, 1.3-34.4). Positivity for antibodies against aquaporin-4 (AQP4-IgG) was identified in 78% of the patients. The mean duration of the treatment with RTX was 40 months (range, 12-61). After the RTX therapy, the number of relapses was reduced in 91% (21/23) of cases. The annualized relapsed rate (ARR) was reduced with RTX from 1.89 to 0.12 (p <0.001). The mean EDSS was also reduced from 4.8 to 3.9 (p = 0.014). In all patients, the mean EDSS was reduced or stabilized with RTX. Overall, the drug was well tolerated, the most frequent adverse events were infections which were present in 65.2% of cases.
CONCLUSIONS
Though with the limitations of and observational study, our data support RTX effectiveness and safety in an Ecuadorian cohort of patients with NMOSD.
背景
视神经脊髓炎谱系疾病（NMOSD）是一种严重的中枢神经系统炎症性脱髓鞘疾病，常导致残疾。基于前瞻性和回顾性研究的证据，利妥昔单抗（RTX）已被用作 NMOSD 的一线治疗药物。然而，缺乏 RTX 对厄瓜多尔 NMOSD 患者复发率和残疾影响的证据。
目的
评估 RTX 对厄瓜多尔 NMOSD 患者队列的影响。
材料和方法
对厄瓜多尔基多一家三级医院接受 RTX 治疗的 NMOSD 患者队列进行回顾性研究。回顾 NMOSD 患者的数字病历，以获取社会人口统计学数据、疾病特征和 RTX 治疗情况。在治疗前后建立了年化复发率（ARR）以及通过扩展残疾量表（EDSS）测量的残疾程度。
结果
共纳入 23 例接受 RTX 治疗的 NMOSD 患者，疾病发病的平均年龄为 37.2 岁（范围 13-64.5 岁）。平均疾病病程为 8.5 年（范围 1.3-34.4 年）。78%的患者存在抗水通道蛋白-4（AQP4-IgG）抗体阳性。RTX 治疗的平均时间为 40 个月（范围 12-61 个月）。RTX 治疗后，91%（21/23）的病例复发次数减少。ARR 从 1.89 降至 0.12（p<0.001）。EDSS 均值也从 4.8 降至 3.9（p=0.014）。所有患者的 EDSS 均值均因 RTX 治疗而降低或稳定。总体而言，该药物具有良好的耐受性，最常见的不良反应是感染，发生率为 65.2%。
结论
尽管本研究存在观察性研究的局限性，但我们的数据支持 RTX 在厄瓜多尔 NMOSD 患者中的有效性和安全性。
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