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)
Aaron Miller1, Laura Popper2, Joseph Berger3, Amit Bar-Or3, Robert Zivadinov4, Alexey Boyko5, Hadar Kolb6, Arnon Karni6, Ornit Almog7, Nadav Bleich Kimelman8, Shai Rubnov8, Uri Danon8, Ehud Marom8
1Mt Sinai School Of Med, 2Mapi Pharma Ltd., 3University of Pennsylvania, 4Buffalo Neuroimaging Analysis Center, 5FCCPSMS Center At Usupov's Hospital, 6Tel Aviv Medical Center, 7Mapi-Pharma, 8Mapi Pharma
Objective:
To analyze the effect of GA Depot on disability accumulation using EDSS data from GA Depot clinical studies in RMS and PPMS patients
Background:
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.
Design/Methods:
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
Results:
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).
Conclusions:
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.
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