Abstract
BackgroundEdaravone was approved as a new treatment for amyotrophic lateral sclerosis (ALS), although there are different opinions on its effectiveness. Magnetic resonance (MRI) measures appear promising as diagnostic and prognostic indicators of disease. However, published studies on MRI using to monitor treatment efficacy in ALS are lacking.PurposeThe objective of this study was to investigate changes in brain MRI measures in patients treated with edaravone.MethodsThirteen ALS patients assuming edaravone (ALS-EDA) underwent MRI at baseline (T0) and after 6 months (T6) to measure cortical thickness (CT) and fractional anisotropy (FA) of white matter (WM) tracts. MRI data of ALS-EDA were compared at T0 with those of 12 control subjects (CS), and at T6 with those of 11 ALS patients assuming only riluzole (ALS-RIL), extracted from our ALS cohort using a propensity-score-matching. A longitudinal MRI analysis was performed in ALS-EDA between T6 and T0.ResultsAt T0, ALS-EDA showed a cortical widespread thinning in both hemispheres, particularly in the bilateral precentral gyrus, and a reduction of FA in bilateral corticospinal tracts, in comparison to CS. Thinning in bilateral precentral cortex and significant widespread reduction of FA in several WM tracts were observed in ALS-EDA at T6 compared to T0. At T6, no significant differences in MRI measures of ALS-EDA versus ALS-RIL were found.ConclusionsPatients treated with edaravone showed progression of damage in the motor cortex and several WM tracts, at a six-month follow-up. Moreover, this study showed no evidence of a difference between edaravone and riluzole.
Highlights
Edaravone was approved as a new treatment for amyotrophic lateral sclerosis (ALS), there are different opinions on its effectiveness
Magnetic resonance imaging (MRI) generated measures have been proposed as potential diagnostic, prognostic biomarkers of ALS, to date, there are no published studies on MRI measures as an indicator of the effectiveness of drugs used in the disease
We have tried to investigate baseline and six-month MRI changes in real life on newly diagnosed ALS patients treated with edaravone, using cortical thickness (CT) and diffusion tensor imaging (DTI) analysis
Summary
Edaravone was approved as a new treatment for amyotrophic lateral sclerosis (ALS), there are different opinions on its effectiveness. Methods Thirteen ALS patients assuming edaravone (ALS-EDA) underwent MRI at baseline (T0) and after 6 months (T6) to measure cortical thickness (CT) and fractional anisotropy (FA) of white matter (WM) tracts. For this reason, edaravone has been proposed, approved and licensed as the first new treatment for ALS after riluzole. The first phase 3 study did not show significant differences in the ALSFRS-r score between patients receiving edaravone and placebo; post hoc analyses identified a subpopulation in which edaravone showed efficacy [3, 4]. No differences in ALS patients treated and not treated with edaravone in terms of disease progression and respiratory function has been reported in a multicenter Italian real-life study [9]
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