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)
Aaron Miller1, Laura Popper2, Joseph Berger3, Amit Bar-Or3, Robert Zivadinov4, hadar kolb5, arnon karni5, Ornit Almog6, nadav kimelman6, Shai Rubnov6, Uri Danon6, Ehud Marom6
1Mt Sinai School Of Med, 2Mapi Pharma Ltd., 3University of Pennsylvania, 4University at Buffalo, 5Tel Aviv Medical Center, 6Mapi Pharma
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.
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