Abstract Details

Title Relapse Is Associated with Residual Deficits in Relapsing-Remitting Multiple Sclerosis: Analysis of FREEDOMS Data

Topic MS and Related Diseases

Presentation(s) P07 - (-)

Poster/Presentation
Number 118

Objective

Background BACKGROUND: Disability progression in relapsing MS may be driven by incomplete recovery following relapses. With treatment, by reducing the number of relapses alone or also by reducing the proportion of relapses for which recovery is incomplete such disability could be reduced.

Design/Methods DESIGN/METHODS: Expanded Disability Status Scale (EDSS) assessments were performed at screening, baseline, and every 3 months, as well as during suspected relapses for confirmation and severity determination. Post-relapse EDSS change was calculated from the score immediately preceding onset of the first confirmed relapse to the first (initial recovery) and lowest (best recovery) scores ?30 days after onset.

Results RESULTS: At initial recovery, 197 (48.8%) patients with confirmed relapse had an EDSS score increase of ?0.5 including 58 on fingolimod 0.5mg, 43 on 1.25mg and 96 on placebo; 115 (28.5%) patients had an EDSS increase of ?1 including 35 on fingolimod 0.5mg, 28 on 1.25mg, and 52 on placebo. At best recovery, 125 (30.9%) patients with confirmed relapse had an EDSS score increase of ?0.5 including 38 on fingolimod 0.5mg, 27 on 1.25mg, and 60 on placebo; 70 (17.3%) patients had an increase of ?1 including 19 on fingolimod 0.5mg, 18 on 1.25mg, and 33 on placebo. More severe relapses were associated with worse outcome.

Conclusions CONCLUSIONS: MS relapses yield residual disability, with more severe relapses associated with greater deficits. While fingolimod reduced the number of MS relapses there was no significant difference for which incomplete recovery occurred. Full recovery may not occur for > 3 months, which has important implications for study design in RRMS as the recovery process can be misread as confirmed disability.

Authors/Disclosures
Gary R. Cutter, PhD (University of Alabama At Birmingham) PRESENTER	Dr. Cutter has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for onsulting or Advisory Boards: Alexion, Antisense Therapeutics/Percheron, Avotres, Biogen, Clene Nanomedicine, Clinical Trial Solutions LLC, Endra Life Sciences, Cognito Therapeutics, Genzyme, Genentech, Immunic, Klein-Buendel Incorporated, Kyverna Therapeutics, Inc. , Linical, Merck/Serono, Noema, Neurogenesis, Perception Neurosciences, Protalix Biotherapeutics, Regeneron, Revelstone Consulting, Roche, SAB Biotherapeutics, Sapience Therapeutics, Scott&Scott LLP, Tenmile.. Dr. Cutter has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Data and Safety Monitoring Boards: Applied Therapeutics, AI therapeutics, AMO Pharma, Argenx, Astra-Zeneca, Avexis Pharmaceuticals, Bristol Meyers Squibb, CSL Behring, Cynata Therapeutics, DiamedicaTherapeutics, Horizon Pharmaceuticals, Immunic, Inhibrix, Karuna Therapeutics, Kezar Life Sciences, Medtronic, Merck, Meiji Seika Pharma, Mitsubishi Tanabe Pharma Holdings, Prothena Biosciences, Novartis, Pipeline Therapeutics (Contineum), Regeneron, Sanofi-Aventis, Teva Pharmaceuticals, United BioSource LLC, University of Texas Southwestern.. Dr. Cutter has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for JASN.
Peter S. Chin, MD (Denali)	No disclosure on file
Gordon S. Francis, MD, FAAN	No disclosure on file
	No disclosure on file
Ron Hashmonay, MD	No disclosure on file
Fred D. Lublin, MD, FAAN (Icahn School of Medicine At Mount Sinai)	Dr. Lublin has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche/Genentech. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurogene. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medimmune/Viela Bio/Horizon. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Receptos/Celgene/BMS. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Labcorp. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neuralight. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Entelexo. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Lublin has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avotres. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Lublin has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Lublin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono. Dr. Lublin has received personal compensation in the range of $100,000-$499,999 for serving as an Expert Witness for Multiple entities. Dr. Lublin has stock in Avotres. Dr. Lublin has stock in Neuralight. The institution of Dr. Lublin has received research support from Brainstorm. The institution of Dr. Lublin has received research support from biogen. The institution of Dr. Lublin has received research support from NIH.
Harold Koendgen, MD	Dr. Koendgen has received personal compensation for serving as an employee of F. Hoffmann-La Roche Ltd. Dr. Koendgen has received stock or an ownership interest from F. Hoffmann-La Roche Ltd .

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