Objective To evaluate the extent to which treatment effect on brain atrophy is able to mediate, at the trial level, the treatment effect on disability progression in Relapsing-Remitting Multiple Sclerosis (RRMS). Methods We collected all published randomized clinical trials in RRMS lasting at least 2 years and including as endpoints: disability progression (defined as 6 or 3 months confirmed 1-point increase in the Expanded Disability Status Scale), active magnetic resonance imaging (MRI) lesions (defined as new/enlarging T2 lesions), and brain atrophy (defined as change in brain volume between month 24 and month 6-12). Treatment effects were expressed as relative reductions. A linear regression, weighted for trial size and duration, was used to assess the relationship between the treatment effects on MRI markers and on disability progression. Results: 13 trials including more than 13500 RRMS patients were included in the meta-analysis. Treatment effects on disability progression were correlated both with treatment effects on brain atrophy (R2=0.48, p=0.001) and on active MRI lesions (R2=0.61, p<0.001). When the effects on both MRI endpoints were included in a multivariate model, the correlation was higher (R2=0.75, p<0.001) and both variables were retained as independently related to the treatment effect on disability progression. Interpretation: In RRMS, the treatment effect on brain atrophy is correlated with the effect on disability progression over 2 years. This effect is independent of the effect of active MRI lesions on disability; the two MRI measures predict the treatment effect on disability more closely when used in combination.
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|Titolo:||Treatment effect on brain atrophy correlates with treatment effect on disability in multiple sclerosis|
|Citazione:||M. P., S., D. L., A., & DE STEFANO, N. (2014). Treatment effect on brain atrophy correlates with treatment effect on disability in multiple sclerosis. ANNALS OF NEUROLOGY, 75(1), 43-49.|
|Appare nelle tipologie:||1.1 Articolo in rivista|