Magnetic Resonance Imaging Measures as Prognostic Parameters for Physical and Cognitive Outcomes up to 8 Years in Patients with Relapsing Forms of Multiple Sclerosis (P5.2-060)

Objective: Assess the predictive value of magnetic resonance imaging (MRI) measures for physical and cognitive outcomes in multiple sclerosis (MS) at ≤8 years. Background: Limited data exist on MRI measures as prognostic parameters in MS. Design/Methods: Post hoc analyses of data from patients with relapsing MS receiving fingolimod in the placebo-controlled, phase 3 FREEDOMS and FREEDOMS II trials and their extensions. Baseline MRI predictors assessed included normalized brain volume (NBV), T1 hypointense lesion volume (T1LV), T2 lesion volume (T2LV) and presence of gadolinium-enhancing (Gd+) lesions. Outcomes were transition to secondary progressive MS (SPMS), confirmed disability improvement (CDI; Expanded Disability Status Scale score decrease of 1.0 or 0.5 points, if Baseline score ≤5.5 or ≥6.0, respectively, confirmed at 6 months), CDI+ (CDI or ≥20% improvement in 9-hole peg or timed 25-foot walk tests confirmed at 6 months) and cognitive worsening (≥20% reduction in paced auditory serial addition test, confirmed at 6 months). Baseline-adjusted Cox proportional hazards model compared risk of worst vs best category; log-rank test determined predictive value of MRI parameters. Most predictors were categorized by quartile; Gd+ lesions were dichotomized by presence/absence. Results: By log-rank test, NBV was significantly predictive of all outcomes tested (p Conclusions: Overall, measures of disease burden such as NBV and lesion volume are more robust prognostic parameters of long-term disease progression than (short-term) MRI lesion activity. Disclosure: Dr. Vollmer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Academic CME, Alcimed, Anthem Blue Cross, Genentech/Roche, Biogen IDEC, Novartis, CellGene, Epigene, Rocky Mountain MS Center, GLG Consulting, Ohio Health, TG Therapeutics, Topaz Therapeutics, Dleara Lawyers, Teva. Dr. Vollmer has received research support from Teva, NIH/NINDS, Rocky Mountain MS Center, Actelion, Roche/Genentech, UT Southwestern, TG Therapeutics. Dr. Haering has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis Pharma AG. Dr. Piani Meier has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis Pharma AG. Dr. Tomic has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Novartis Pharma AG. Dr. Sprenger has nothing to disclose. Dr. Jeffery has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Personal compensation for speaking or consulting services from Acorda, Bayer, Biogen, Genentech, GlaxoSmithKline, Novartis, Questcor, Serono and Teva. Dr. Jeffery has received research support from Research funding from Biogen and Genentech.