Abstract Details

Title MRI Outcomes in CombiRx: Blinded, 7-Year Extension Results

Topic MS and Related Diseases

Presentation(s) S01 - (-)

Poster/Presentation
Number 003

Background CombiRx was a double-blind, placebo-controlled, multi-center randomized clinical trial comparing combined interferon beta-1a (IFN) 30ug IM weekly and glatiramer acetate (GA) 20mg daily to each agent alone in relapsing-remitting multiple sclerosis (RRMS). MRIs were done at baseline, and planned at 6 months, years 1-4, 6 and at study termination; three year results were presented.

Objective

Design/Methods 1008 participants were followed until the last participant enrolled completed 3 yrs; 80.1% completed 3 years and 84.4% continued into the extension. At least one extension MRI was assessed for numbers of enhanced, and unenhanced new or substantially enlarged T2 lesions (combined unique activity, CUA), total lesion volumes and their strictly T2 and T1 components, and atrophy for 84.1% of trial subjects. Proportions are for those with MRI at that time period.

Results MRI characteristics at years 4, 5 and 6: 13.2%, 9.5% and 3.7% of participants had enhancements at the respective years. Median total lesion volumes were 6.8 ml at year 4 and 6.6 ml at year 6. Cumulative CUA free by treatment arm at year 4 for IFN+GA: 48.1%, IFN: 30.9%, GA: 30.8% (IFN vs GA p=0.67, IFN+GA vs IFN p=0.0007). Mean change in total lesion volume at year 4 for IFN+GA: -1.57, IFN: -0.25, GA: 0.46 (IFN vs GA p=0.22, IFN+GA vs IFN p=0.04). Data for T2-hyperintense and T1-hypointense lesion components and global tissue loss will be presented.

Conclusions These results suggest that the stabilization of acute and more chronic measures of MRI-defined disease activity and tissue loss observed over the first three years of the trial continued on extended therapy in all three treatment arms. Reduced activity changes appeared more robust for those subjects initially randomized to combined therapy.

Authors/Disclosures
Jerry S. Wolinsky, MD, FAAN (McGovern Medical School, UTHealth) PRESENTER	Dr. Wolinsky has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avotres. Dr. Wolinsky has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Brainstorm Cell Therapeutics. Dr. Wolinsky has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cleveland Clinic Foundation. Dr. Wolinsky has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Wolinsky has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Inmagene. Dr. Wolinsky has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis/Sandoz. Dr. Wolinsky has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Wolinsky has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi/Genzyme. Dr. Wolinsky has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for University of Alabama Birmingham. Dr. Wolinsky has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Wolinsky has received intellectual property interests from a discovery or technology relating to health care. Dr. Wolinsky has received intellectual property interests from a discovery or technology relating to health care.
Amber Salter, PhD (UT Southwestern Medical Center)	Dr. Salter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gryphon Bio. Dr. Salter has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abata Therapeutics. Dr. Salter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sora Neuroscience. Dr. Salter has stock in Owl Therapeutics. The institution of Dr. Salter has received research support from National Multiple Sclerosis Society. The institution of Dr. Salter has received research support from Department of Defense Congressionally Directed Medical Research Program. The institution of Dr. Salter has received research support from Consortium of Multiple Sclerosis Centers. The institution of Dr. Salter has received research support from Multiple Sclerosis Society of Canada.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Flavia Nelson, MD (University of Miami, Miller School of Medicine)	Dr. Nelson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Brystol Meyer Squib. Dr. Nelson has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Nelson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genetech. The institution of Dr. Nelson has received research support from NIH.
Stacey Cofield	No disclosure on file
Gary R. Cutter, PhD (University of Alabama At Birmingham)	Dr. Cutter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biodelivery Sciences International, Biogen, Click Therapeutics, Genzyme, Genentech, GW Pharmaceuticals, Immunic, Klein-Buendel Incorporated, Medimmune/Viela Bio, Medday, Merck/Serono, Neurogenesis LTD, Novartis, Osmotica Pharmaceuticals, Perception Neurosciences, Recursion/Cerexis Pharmaceuticals, Regeneron, Reckover Pharmaceuticals, Roche, TG Therapeutics.. Dr. Cutter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Applied Therapeutics, AI therapeutics, AMO Pharma, Astra-Zeneca, Avexis Pharmaceuticals, Biolinerx, Brainstorm Cell Therapeutics, Bristol Meyers Squibb/Celgene, CSL Behring, Galmed Pharmaceuticals, Green Valley Pharma, Horizon Pharmaceuticals, Immunic, Karuna Therapeutics, Mapi Pharmaceuticals LTD, Merck, Mitsubishi Tanabe Pharma Holdings, Opko Biologics,Prothena Biosciences, Novartis, Regeneron, Sanofi-Aventis, Reata Pharmaceuticals, NHLBI (Protocol Review Committee), University of Texas Southwestern, University of Pennsylvania, Visioneering Technologies, Inc.. Dr. Cutter has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for JASN.
Robin A. Conwit, MD, FAAN	Dr. Conwit has nothing to disclose.
Tarah Gustafson	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.
Sergiusz Jozwiak	No disclosure on file

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