Feasibility of Brain Atrophy Measurement in Clinical Routine without Prior Standardization of the MRI Protocol: Results from MS-MRIUS, a Longitudinal Observational, Multicenter Real-World Outcome Study in Patients with Relapsing-Remitting MS

Abstract

BACKGROUND AND PURPOSE: Feasibility of brain atrophy measurement in patients with MS in clinical routine, without prior standardization of the MRI protocol, is unknown. Our aim was to investigate the feasibility of brain atrophy measurement in patients with MS in clinical routine.

Fingolimod's Impact on MRI Brain Volume Measures in Multiple Sclerosis: Results from MS‐MRIUS

“…MS‐MRIUS is one of the first studies to collect MRI and clinical data, including data on brain atrophy, from multiple MS centers that followed patients in routine clinical practice, in order to provide evidence of fingolimod's impact on the four key measures of disease activity (relapses, lesions, disability, and brain atrophy) in a real‐world setting …”

“…MS‐MRIUS is a multicenter, observational, longitudinal cohort study in routine clinical practice that retrospectively analyzed 590 relapsing‐remitting MS (RRMS) patients who initiated on fingolimod .5 mg . Patients with RRMS in whom fingolimod treatment were initiated de novo were identified between August 2014 and June 2016 from 33 participating MS centers across the USA.…”

“…MRI exams needed to be performed on 1.5T or 3T scanners, and no prior standardization was expected . All eligible scans needed to have a 2D or a 3D FLAIR sequence or a 2D or 3D T1‐WI with and/or without Gd contrast.…”

“…Because the RCTs are designed to include narrowly defined, optimal conditions in specific populations, real‐world studies are necessary to investigate safety and efficacy outcomes of DMTs in a more heterogeneous group's patients, more representative of the overall MS population followed in clinical practice . While the routine assessment of the lesion outcomes is part of standard magnetic resonance imaging (MRI) monitoring in MS, the examination of brain volume changes is limited due to the lack of standardized image acquisition technology and image analysis . This limits direct comparisons of the efficacy of DMTs in a clinical routine on brain atrophy outcomes, on both group and individual patient levels.…”

“…MS and clinical outcome and MRI in the United States (MS‐MRIUS) was the first multicentre, retrospective observational study that investigated feasibility of brain atrophy measurement in patients with MS, in a routine clinical practice setting . MS‐MRIUS showed that brain volume loss was readily assessed by estimating percentage lateral ventricular volume change (PLVVC) on T2‐weighted fluid‐attenuated inversion recovery (FLAIR), compared to percentage brain volume change (PBVC) or PLVVC using 2‐dimensional (2D)‐ or 3‐dimensional (3D) T1‐weighted imaging (WI) in this observational retrospective study …”