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哥伦比亚诊断为复发缓解型多发性硬化症患者接受阿仑单抗治疗的真实世界证据。

Real-life evidence of treatment with alemtuzumab in patients diagnosed with relapsing-remitting multiple sclerosis in Colombia.

机构信息

Clinical neurologist, specialist in multiple sclerosis, Clínica de Marly, Bogotá-Colombia.

Clinical neuropsychologist, Clínica de Marly, Bogotá, Colombia.

出版信息

Mult Scler Relat Disord. 2022 May;61:103780. doi: 10.1016/j.msard.2022.103780. Epub 2022 Mar 27.

DOI:10.1016/j.msard.2022.103780
PMID:35397291
Abstract

BACKGROUND

Physical disability, cognitive impairment, depression, and fatigue are poorly understood in Latin American patients with multiple sclerosis following alemtuzumab infusion.

OBJECTIVES

To describe Sustained changes in physical disability in an average 22-month follow-up period after alemtuzumab infusion, and which demographical or clinical variables modulate change in EDSS, and adverse events, changes in cognition, fatigue, and depressive symptoms after an average 15-month follow-up period.

METHOD

Retrospective cohort observational study. Following the review of medical records, 23 patients with Relapsing Remitting Multiple Sclerosis treated with alemtuzumab were identified; of these, 17 had a baseline neuropsychological assessment and 12 had at least one follow-up neuropsychological assessment.

RESULTS

Most of the patients presented a low level of physical disability, depression, fatigue, and cognitive impairment, which was more pronounced in the processing speed and visuospatial memory at baseline. Fifteen of 23 (65.2%) of patients showed disability improvement, 7 (30.1%) patients remained stable, and 1 (4.3%) patient worsened, and change was not influenced by age or baseline disability score. Twenty (87%) patients remained free of clinical relapses. Performance improved on the BVMT-R visual memory test, 9 (75%) remained stable or improved on the BICAMS, and 66.6% perceived decreased fatigue on the d-FIS. Adverse events occurred in 7 (30.1%) of patients, the most common were opportunistic infections in 2 (8.6%) patients, and one 29-year-old patient presented papillary thyroid carcinoma after infusion of the second course of alemtuzumab.

CONCLUSIONS

Results suggest that treatment with alemtuzumab has a beneficial impact on disability, cognitive impairment, and perception of fatigue. The percentage and type of adverse events observed in the cohort are similar to those reported for other real-life studies.

摘要

背景

在接受阿仑单抗输注的拉丁美洲多发性硬化症患者中,身体残疾、认知障碍、抑郁和疲劳的情况了解甚少。

目的

描述阿仑单抗输注后平均 22 个月的随访期间身体残疾的持续变化,并描述哪些人口统计学或临床变量会影响 EDSS 的变化,以及平均 15 个月随访期间认知、疲劳和抑郁症状的变化。

方法

回顾性队列观察性研究。在审查病历后,确定了 23 名接受阿仑单抗治疗的复发性缓解型多发性硬化症患者;其中,17 名患者有基线神经心理学评估,12 名患者至少有一次随访神经心理学评估。

结果

大多数患者的身体残疾、抑郁、疲劳和认知障碍程度较低,在基线时,处理速度和视觉空间记忆方面更为明显。23 名患者中有 15 名(65.2%)的残疾改善,7 名(30.1%)患者保持稳定,1 名(4.3%)患者恶化,变化不受年龄或基线残疾评分的影响。20 名(87%)患者仍无临床复发。BVMT-R 视觉记忆测试的表现有所改善,9 名(75%)患者在 BICAMS 上保持稳定或改善,66.6%的患者认为疲劳感减轻。7 名(30.1%)患者出现不良事件,最常见的是 2 名(8.6%)患者发生机会性感染,1 名 29 岁患者在接受第二次阿仑单抗输注后出现甲状腺乳头癌。

结论

结果表明,阿仑单抗治疗对残疾、认知障碍和疲劳感有有益的影响。该队列中观察到的不良事件的比例和类型与其他真实世界研究报告的相似。

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