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

Perda de volume cerebral e comprometimento físico e cognitivo em pacientes recém-diagnosticados com esclerose múltipla tratados com fingolimode: estudo de coorte prospectivo em Buenos Aires, Argentina

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 1st 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 3rd 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 3rd year, 14% of the patients were classified as CI and 6.2% had EDSS progression. In the CI group, the PBVL during the 1st 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 1st 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 1st year in naïve MS patients was independently associated with a significant risk of CI and EDSS progression.

Keywords:
Multiple Sclerosis; Cognitive Dysfunction; Disabled Persons; Biomarkers; Fingolimod Hydrochloride; Argentina

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