Impact of fingolimod on MRI brain volume measures in routine clinical practice: results from MS-MRIUS, a longitudinal observational, multicenter real-world outcome study in RRMS patients (P5.350)

Objective: To investigate fingolimod effect on MRI efficacy measures, among patients with relapsing-remitting multiple sclerosis (RRMS), in clinical routine. Background: There is lack of evidence on the effect of fingolimod on changes in brain volume outcomes in the multicenter real-world clinical setting. Design/Methods: Multiple Sclerosis and clinical outcome and MRI in the US (MS-MRIUS) is a multicenter (33 sites), retrospective study that included ~600 RRMS patients in the US, who initiated fingolimod. Brain MRI outcomes were analyzed from scans taken during the index period (−6 months before or +1 month after fingolimod initiation (FI)), post index (9–24 months after FI) and optional pre-index period (9–24 months before FI). Primary MRI endpoints included annualized percent change in whole brain (WB) and lateral ventricle volume (LVV), accumulation of Gd enhancing (Gd+) and new/enlarging T2 lesions and absolute changes in T2- and T1- lesion volumes (LVs). Results: A total of 571 patients met the clinical and MRI inclusion/exclusion criteria at index. Of those, 178 (31%) also had pre-index MRI data. Mean follow-up was 16 months. Median annualized WB volume loss was 0.34% in the pre-index to index (n=105) and 0.30 in the index to post-index (n=381) period. Annualized median LVV increased by 2.07% in the pre-index to index (n=171) and by 0.83% in the index to post-index (n=562) period. The Gd+ lesion number was 0.82 at pre-index, 0.71 at index and 0.12 at post-index with 94.5% of fingolimod treated patients not having Gd+ lesions at post-index. The accumulation of new/enlarging T2 lesions was 1.01 in the pre-index to index and 0.43 in the index to post-index period. The accumulation of T2 and T1-LV was lower on fingolimod. Conclusions: Fingolimod was associated with decrease in rate of brain volume loss and improvement in lesion measures consistent to findings in pivotal clinical trials. Study Supported by: Acknowledgments MS-MRIUS Principal Investigators and study coordinators for providing data. Disclosure: Study Supported by: Novartis Pharmaceuticals AG Disclosure: Dr. Zivadinov has received personal compensation for activities with EMD Serono, Genzyme, Novartis, for speaking and consultant fees. Dr. Zivadinov has received personal compensation in an editorial capacity for BioMed Research International, BMC Medicine, BMC Neurology, Clinical CNS Drugs, Conf Pap Neurosci, Journal of Alzheimer9s Disease, Vein and Lymphatics, and Word J Surg Proc. Dr. Zivadinov has received research support from Biogen Idec, Claret Medical, Genzyme, Intekrin-Coherus, Novartis, and Teva Pharmaceuticals. Dr. Khan has received personal compensation for activities with QuintilesIMS, Switzerland as a consultant. Dr. Medin has received personal compensation for activities with Novartis Pharma AG as an employee. Dr. Korn has received personal compensation for activities with QuintilesIMS. Dr. Bergsland has nothing to disclose. Dr. Dwyer has received personal compensation for activities with Claret Medical and EMD Serono. Dr. Dwyer has received research support from Novartis. Dr. Price has received personal compensation for activities with QuintilesIMS, Switzerland as an employee. Dr. Silva has received personal compensation for activities with Novartis Pharmaceuticals as an employee. Dr. Chitnis received personal compensation for activities with Roche-Genentech and Sanofi-Genzyme. Dr. Chitnis received research support from EMD Serono, Biogen, Novartis and Verily. Dr. Naismith has received personal compensation for activities with Acorda, Alkermes, Bayer, Biogen, EMD Serono, Genentech, Genyzme, Novartis, and Teva. Dr. Naismith has received research support from Alkermes. Dr. Alvarez has received personal compensation from Teva Neuroscience, Biogen, Genzyme, Genentech, and Novartis. Dr. Alvarez has received research support from Biogen, Teva, and Novartis. Dr. Kinkel has received personal compensation for activities with Novartis as a consultant. Dr. Weinstock-Guttman has received personal compensation for activities with Biogen, Teva Pharmaceuticals, EMD Serono, Genzyme&Sanofi, Novartis and Genentech as a speaker and consultant. Dr. Weinstock-Guttman has received research support from Biogen, Teva Pharmaceuticals, EMD Serono, Genzyme & Sanofi, Novartis, Genentech.