An Observational Study to Assess Brain MRI Change and Disease Progression in Multiple Sclerosis Clinical Practice—The MS‐MRIUS Study

Abstract

BACKGROUND & PURPOSETo describe methodology, interim baseline, and longitudinal magnetic resonance imaging (MRI) acquisition parameter characteristics of the multiple sclerosis clinical outcome and MRI in the United States (MS‐MRIUS).MATERIAL & METHODSThe MS‐MRIUS is an ongoing longitudinal and retrospective study of MS patients on fingolimod. Clinical and brain MRI image scan data were collected from 600 patients across 33 MS centers in the United States. MRI brain outcomes included change in whole‐brain volume, lateral ventricle volume, T2‐ and T1‐lesion volumes, and new/enlarging T2 and gadolinium‐enhancing lesions.RESULTSInterim baseline and longitudinal MRI acquisition parameters results are presented for 252 patients. Mean age was 44 years and 81% were female. Forty percent of scans had 3‐dimensional (3D) T1 sequence in the preindex period, increasing to 50% in the postindex period. Use of 2‐dimensional (2D) T1 sequence decreased over time from 85% in the preindex period to 65% in the postindex. About 95% of the scans with FLAIR and 2D T1‐WI were considered acceptable or good quality compared to 99–100% with 3D T1‐WI. There were notable changes in MRI hardware, software, and coil (39.5% in preindex to index and 50% in index to postindex). MRI sequence parameters (orientation, thickness, or protocol) differed for 36%, 29%, and 20% of index/postindex scans for FLAIR, 2D T1‐WI, and 3D T1‐WI, respectively.CONCLUSIONSThe MS‐MRIUS study linked the clinical and brain MRI outcomes into an integrated database to create a cohort of fingolimod patients in real‐world practice. Variability was observed in MRI acquisition protocols overtime.

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.…”

“…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 …”

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

“…The methodologic approach and design of this retrospective study have been previously reported. 18 Briefly, clinical information and digital brain MR imaging image data were retrospectively collected from 33 participating academic and nonacademic MS centers across the United States and integrated into a central research data base.…”