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Abstract Details

GA Depot (Long-acting IM Injection of Glatiramer Acetate) Impact on EDSS Stability in Relapsing Forms of Multiple Sclerosis (RMS) and Primary Progressive Multiple Sclerosis (PPMS)
Multiple Sclerosis
P11 - Poster Session 11 (8:00 AM-9:00 AM)
1-014
 To analyze the effect of GA Depot on disability accumulation using EDSS data from GA Depot clinical studies in RMS and PPMS patients
Multiple sclerosis (MS) is a chronic disease requiring lifelong therapy, where patients accumulate disability over time, as measured by the Expanded Disability Status Scale (EDSS). Glatiramer acetate (GA) Depot, a formulation of GA in extended-release microspheres, is administered intramuscularly once every 28 days. 
EDSS data were collected from three GA Depot studies: i) a double-blind, placebo-controlled, phase III study with 508 RMS patients randomized to the active arm; ii) interim analysis of an ongoing, open-label, long-term phase IIa study in 13 RMS patients; and iii) interim analysis of an ongoing open-label phase IIa study in 30 PPMS patients
 In the phase III RMS study, the mean EDSS score in the GA Depot group was 2.6 at baseline and 2.5 at week 52 (end of the placebo-controlled period). Results of the mixed model repeated measures (MMRM) analysis showed a statistically significant small numerical reduction in mean EDSS at Week 52 for GA Depot over Placebo (LS means difference: -0.058; p=0.0191). In a responder analysis, 96.4% of GA Depot-treated patients showed no increase in EDSS at Week 52 vs. 91.6% in the placebo group (p=0.0068). In the long-term RMS study, EDSS remained stable over six years, from 2.7 at baseline to 1.9 at the end. In the PPMS study, the mean EDSS score remained stable, with a baseline of 5.1 and 4.9 at year 3 (end of the study). 

GA Depot appears to maintain a stabilizing effect on EDSS scores across three studies in RMS and PPMS patients. This effect was consistent regardless of baseline EDSS, supporting the role of GA Depot in preventing disability accumulation, a critical goal in MS treatment.
Authors/Disclosures
Aaron E. Miller, MD, FAAN (Mt Sinai School Of Med)
PRESENTER 		Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Accordant Health Services (Caremark). Dr. Miller has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Corevitas (formerly known as Corrona). Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for MAPI=Pharma. Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Viatris (Mylan). Dr. Miller has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Guidepoint Global. Dr. Miller has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gerson Lehrman Group. Dr. Miller has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen Idec. Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Dr. Miller has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen (Horizon Therapeutics). Dr. Miller has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Sterne Kessler. Dr. Miller has received publishing royalties from a publication relating to health care.
Laura Popper, MD (Mapi Pharma Ltd.) Dr. Popper has received personal compensation for serving as an employee of Mapi Pharma.
Joseph R. Berger, MD, FAAN Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb/Celgene. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cycle Pharma. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dice Therapeutics. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech/Roche. Dr. Berger has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Gilead. Dr. Berger has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck/. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Morphic. Dr. Berger has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MAPI. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ExcisionBio. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Population Bio. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TG Therapeutics. Dr. Berger has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Assorted .
Amit Bar-Or, MD, FRCPC (University of Pennsylvania) Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Genentech. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merk/EMD Serono. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for cabaletta. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck/EMD Serono. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi/Genzyme. The institution of Dr. Bar-Or has received research support from Novartis. The institution of Dr. Bar-Or has received research support from Biogen. The institution of Dr. Bar-Or has received research support from Roche/Genentech.
Robert Zivadinov, MD, PhD, FAAN (Buffalo Neuroimaging Analysis Center) The institution of Dr. Zivadinov has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. The institution of Dr. Zivadinov has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Omnicuris. The institution of Dr. Zivadinov has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Myrobalan. Dr. Zivadinov has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Zivadinov has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Zivadinov has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bristol Myers Squibb. The institution of Dr. Zivadinov has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen.
Alexey Boyko, MD, PhD (FCCPSMS Center At Usupov's Hospital) No disclosure on file
Hadar Kolb Hadar Kolb has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Hadar Kolb has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Hadar Kolb has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for MAPI pharma. Hadar Kolb has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neopharm Scientific. Hadar Kolb has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Marck. The institution of Hadar Kolb has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MAPI pharma. Hadar Kolb has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medison pharma. Hadar Kolb has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Marck.
Arnon Karni No disclosure on file
Ornit Almog Mrs. Almog has nothing to disclose.
Nadav Bleich Kimelman Nadav Bleich Kimelman has nothing to disclose.
Shai Rubnov Shai Rubnov has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Mapi pharma.
Uri Danon Uri Danon has received personal compensation for serving as an employee of Mapi harma.
Ehud Marom Mr. Marom has received personal compensation for serving as an employee of Mapi Pharma. Mr. Marom has received personal compensation in the range of $500,000-$999,999 for serving as an officer or member of the Board of Directors for Mapi Pharma. Mr. Marom has stock in Mapi Pharma. Mr. Marom has received intellectual property interests from a discovery or technology relating to health care.