Author Of 2 Presentations
LB1228 - Glatiramer Acetate Depot (Extended-Release) Phase IIa Study in Patients with RRMS: Safety, Tolerability and Efficacy Four-Years Analysis (ID 2107)
Abstract
Background
Multiple sclerosis is a chronic disease, requiring lifelong therapy. While several DMTs have been approved, improvement of treatment adherence remains an unmet need. Glatiramer acetate (GA) long-acting injection (GA Depot) consists of extended-release microspheres containing GA, administered intramuscularly once every 28 days. Results of GA Depot phase IIa one-year core study and three years extension period in relapsing remitting MS (RRMS) suggest that GA Depot is safe, tolerable and efficacious.
Objectives
Assess the safety, tolerability and efficacy by NEDA-3, defined as: no relapses, no 12-week confirmed disability progression, no new T2 lesions and no gadolinium-enhancing lesions on MRI after three years of treatment with GA Depot in the subpopulation of 10 RRMS patients who completed the core study and continued through three years of the study extension.
Methods
Eligibility criteria included: age 18-70 years, diagnosis of RRMS and treatment with Copaxone® for ≥12 months prior to enrollment. Patients received monthly GA Depot at doses of 80mg or 40mg in the core study and 40mg in the study extension.
Results
Adverse events (AEs) mainly included mild injection site reactions. No unexpected AEs were reported. The number of AEs was significantly reduced during the extension study compared to the core study, and during the fourth extension year compared to the first two years of the study. No systemic immediate post-injection reactions were detected. Patients received all injections as per protocol. Data analyzed by intention to treat population (mITT) (n=10): Mean EDSS score after four years showed no change compared to baseline. No Relapses or MRI activity was noted during that period. Four years NEDA-3 was achieved by 90% of the per protocol population.
Conclusions
Encouraging results of the GA Depot four-year study support its long-term safety, tolerability, and efficacy in this study cohort. It further supports the assumption of GA Depot’s potential to improve MS treatment by significantly reducing frequency of injections, increasing adherence and providing a therapeutic benefit.
P0602 - Long-lasting effects of optic neuritis on anatomical and functional visual network patterns (ID 1326)
Abstract
Background
The brain's ability to adapt in response to damage is debated in multiple sclerosis (MS) literature. In a previous work, we have shown that following the acute damage caused to the visual system by an episode of optic neuritis (ON), the functional visual network experiences changes that are associated with the specific neurologic deficit, all within the limits of the underlying disease pathophysiology.
Objectives
To examine whether the changes associated with ON in the structural and functional networks, can still be discerned in progressive MS patients, even years after the acute insult.
Methods
Forty-eight progressive MS patients, with and without prior ON (MS-ON and MS-nON, respectively; nMS-ON = 21, nMS-nON = 27), underwent structural and functional magnetic resonance imaging (MRI), including diffusion tensor imaging (DTI) and resting state fMRI (RS-fMRI). Anatomical and functional visual networks were defined using 50 visual regions-of-interest. Data were analyzed using graph theory-based methods and weighted network metrics were extracted, including density, strength, global and local efficiency, and modularity.
Results
Preliminary results have shown that while no functional metrics were significantly different between the two groups, anatomical global efficiency and density were significantly higher for the MS-nON group, despite no significant difference in lesion load between the groups.
Conclusions
The anatomical networks of the MS-ON group appear to be more damaged than those of the MS-nON group, while the functional networks appear to function to the same degree. Anatomical connectivity seems influenced by the long- standing distal damage to the optic nerve, suggesting trans-synaptic effects. However, despite our previous study having shown possibly-adaptive functional changes in the visual network following acute ON, our current results suggest that even if the MS brain has the ability to respond and adapt to insult in the early stages of the disease, this ability is nullified in progressive patients.