Abstract Details

Title GA Depot (Long-acting IM Glatiramer Acetate) and its Impact on EDSS in Relapsing Forms of Multiple Sclerosis (RMS) and Primary Progressive Multiple Sclerosis (PPMS)

Topic Multiple Sclerosis

Presentation(s) P7 - Poster Session 7 (8:00 AM-9:00 AM)

Poster/Presentation
Number 19-002

Objective

To evaluate the impact of GA Depot on EDSS stability in patients with RMS and PPMS based on two clinical studies data, including analysis of early discontinued patients.

Background Multiple sclerosis (MS) is a chronic inflammatory, demyelinating disease characterized by neurological disability accumulation over time. The Expanded Disability Status Scale (EDSS) is widely used to assess disability worsening in both relapsing and progressive MS. Glatiramer acetate (GA) Depot is a long-acting intramuscular (IM) formulation of GA administered once every 28 days.

Design/Methods

EDSS assessments were collected from two prospective GA Depot studies:

* Up to three years, open-label, phase IIa study in PPMS patients (n=30).

* A one-year, double-blind, placebo-controlled, pivotal phase III study in RMS patients (n=1,016; 508 in the active arm).

A post hoc analysis assessed EDSS changes in patients who discontinued early across both studies

Results In the PPMS study, mean EDSS was 5.1 at baseline and 4.9 at week 148. In the RMS study, mean EDSS in the GA Depot group was 2.6 at baseline and 2.5 at Week 52. The Mixed Model Repeated Measures (MMRM) analysis showed a small but statistically significant EDSS reduction in GA Depot group vs. placebo at Week 52. A post hoc responder analysis found 96.4% of GA Depot-treated patients had no EDSS increase vs. 91.6% with placebo (p=0.0068), indicating more patients remained stable with GA Depot. Subgroup analysis of early discontinued patients showed no EDSS change from baseline to last available assessment: in the PPMS study, baseline mean EDSS 5.4 vs. 5.3, while in the RMS study, mean EDSS 2.6 at both baseline and their last assessment.

Conclusions

GA Depot showed EDSS stabilization in both RMS and PPMS, irrespective of baseline EDSS. These findings suggest its potential in slowing disability progression, reinforcing its role in MS management.

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.
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, MD, PhD (Tel Aviv Sourasky medical center)	Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neopharm. Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. The institution of Prof. Karni has received research support from Medison. The institution of Prof. Karni has received research support from BMS. The institution of Prof. Karni has received research support from Novartis.
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.

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