Brain volume loss and physical and cognitive impairment in naive multiple sclerosis patients treated with fingolimod: prospective cohort study in Buenos Aires, Argentina

阿根廷布宜诺斯艾利斯一项前瞻性队列研究:接受芬戈莫德治疗的初治多发性硬化症患者的脑容量减少以及身体和认知功能障碍

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Abstract

BACKGROUND: The percentage of brain volume loss (PBVL) has been classically considered as a biomarker in multiple sclerosis (MS). OBJECTIVE: The objective of the present study was to analyze if the PBVL during the 1(st) year after the onset of the disease predicts physical and cognitive impairment (CI). METHODS: Prospective study that included naïve patients without cognitive impairment who initiated MS treatment with fingolimod. Patients were followed for 3 years and relapses, expanded disability status scale (EDSS) progression (defined as worsening of 1 point on the EDSS), the annual PBVL (evaluated by structural image evaluation using normalization of atrophy [SIENA]), and the presence of CI were evaluated. Cognitive impairment was defined in patients who scored at least 2 standard deviations (SDs) below controls on at least 2 domains. The PBVL after 1 year of treatment with fingolimod was used as an independent variable, while CI and EDSS progression at the 3(rd) year of follow-up as dependent variables. RESULTS: A total of 71 patients were included, with a mean age of 35.4 ± 3 years old. At the 3(rd) year, 14% of the patients were classified as CI and 6.2% had EDSS progression. In the CI group, the PBVL during the 1(st) year was - 0.52 (±0.07) versus -0.42 (±0.04) in the no CI group (p < 0.01; odds ratio [OR] = 2.24; 95% confidence interval [CI]: 1.72-2.44). In the group that showed EDSS progression, the PBVL during the 1(st) year was - 0.59 (±0.05) versus - 0.42 (±0.03) (p < 0.01; OR = 2.33; 95%CI: 1.60-2.55). CONCLUSIONS: A higher PBVL during the 1(st) year in naïve MS patients was independently associated with a significant risk of CI and EDSS progression.

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