Biological activity of glatiramer acetate on Treg and anti-inflammatory monocytes persists for more than 10 years in responder multiple sclerosis patients

Background: Multiple sclerosis is an autoimmune chronic inflammatory disease of the central nervous system that can lead to some serious disabilities. Despite using various immunomodulatory and anti-inflammatory drugs that have therapeutic effects, they cannot reduce its progression completely, and have some unwanted side effects too. The immunomodulatory and anti-inflammatory effects of the β-D-Mannuronic acid [M2000] have been proven in several surveys, and the present research was designed to determine its toxicity and therapeutic effects in MS patients. Methods: This study was performed on 15 MS patients who took 25 mg/kg/day the oral form of the β-D-Mannuronic acid for six months, and 15 healthy people as a control group. Serum levels of Urea, Creatinine, GGT, Vitamin D3, Uric acid, and Anti-Phospholipids were compared to evaluate the therapeutic and possible toxic effects of this drug after this period. Results: Non- toxic effects through the study of Urea, Creatinine, GGT, and non-significant changes in Uric acid and AntiPhospholipids levels, besides a significant rise in Vitamin, D3 levels in the M2000 treated cases were found. Conclusions: Our results suggested that β-D-Mannuronic acid is a safe drug and has no toxicity when administered orally and also has some therapeutic effects in MS patients.

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Brain Atrophy Rates for Stable Multiple Sclerosis Patients on Long-Term Fingolimod versus Glatiramer Acetate

Frontiers in Neurology ◽

10.3389/fneur.2020.01045 ◽

2020 ◽

Vol 11 ◽

Author(s):

Justin M. Honce ◽

Kavita V. Nair ◽

Brian D. Hoyt ◽

Rebecca A. Seale ◽

Stefan Sillau ◽

...

Keyword(s):

Multiple Sclerosis ◽

Glatiramer Acetate ◽

Brain Atrophy ◽

Multiple Sclerosis Patients

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The brain antigen-specific B cell response correlates with glatiramer acetate responsiveness in relapsing-remitting multiple sclerosis patients

Scientific Reports ◽

10.1038/srep14265 ◽

2015 ◽

Vol 5 (1) ◽

Cited By ~ 5

Author(s):

Damiano M. Rovituso ◽

Cathrina E. Duffy ◽

Michael Schroeter ◽

Claudia C. Kaiser ◽

Christoph Kleinschnitz ◽

...

Keyword(s):

Multiple Sclerosis ◽

B Cell ◽

Glatiramer Acetate ◽

Cell Response ◽

Brain Antigen ◽

Relapsing Remitting ◽

Remitting Multiple Sclerosis ◽

Multiple Sclerosis Patients ◽

Relapsing Remitting Multiple Sclerosis ◽

The Brain

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Metabolic response to glatiramer acetate therapy in multiple sclerosis patients

BBA Clinical ◽

10.1016/j.bbacli.2016.10.004 ◽

2016 ◽

Vol 6 ◽

pp. 131-137 ◽

Cited By ~ 8

Author(s):

Lidia De Riccardis ◽

Alessandra Ferramosca ◽

Antonio Danieli ◽

Giorgio Trianni ◽

Vincenzo Zara ◽

...

Keyword(s):

Multiple Sclerosis ◽

Glatiramer Acetate ◽

Metabolic Response ◽

Multiple Sclerosis Patients

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Long-term efficacy and safety of three times weekly dosing regimen of glatiramer acetate in relapsing multiple sclerosis patients: Seven-year results of the Glatiramer Acetate Low-frequency Administration (GALA) open-label extension study

Multiple Sclerosis Journal - Experimental Translational and Clinical ◽

10.1177/20552173211061550 ◽

2021 ◽

Vol 7 (4) ◽

pp. 205521732110615

Author(s):

Peter Rieckmann ◽

Robert Zivadinov ◽

Alexey Boyko ◽

Krzysztof Selmaj ◽

Jessica K. Alexander ◽

...

Keyword(s):

Multiple Sclerosis ◽

Glatiramer Acetate ◽

Low Frequency ◽

Exposure Period ◽

Similar Efficacy ◽

Open Label ◽

Open Label Extension ◽

Multiple Sclerosis Patients ◽

Relapsing Multiple Sclerosis

Objective Describe the long-term outcomes of early-start (ES) and delayed-start (DS) glatiramer acetate 40 mg/mL treatment three times weekly (GA40) for up to seven years in the Glatiramer Acetate Low-frequency Administration (GALA) study in patients with relapsing multiple sclerosis (RMS). Methods Patients were evaluated every three to six months. The primary efficacy endpoint was annualized relapse rate (ARR); additional endpoints were exploratory or post hoc. For efficacy, data from the entire exposure period were used for the ES and DS cohorts. For safety, exposure only under GA40 was considered. Results Of the patients who continued into the open-label extension (OLE), 580/834 (70%) ES and 261/419 (62%) DS completed the OLE. For the entire placebo-controlled and OLE study period, ARR was 0.26 for ES and 0.31 for DS patients (risk ratio = 0.83; 95% confidence interval [CI]: 0.70–0.99). ES prolonged median time to first relapse versus DS (4.9 versus 4.3 years; hazard ratio = 0.82; 95% CI: 0.6–0.96). OLE-only results showed DS patients experienced similar efficacy for relapse and disability outcomes as ES patients. Adverse events were consistent with the well-established GA safety profile. Conclusions GA40 treatment conferred clinical benefit up to seven years, resulting in sustained efficacy and was generally well tolerated in RMS patients.

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Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years

Multiple Sclerosis Journal ◽

10.1177/135245850000600407 ◽

2000 ◽

Vol 6 (4) ◽

pp. 255-266 ◽

Cited By ~ 150

Author(s):

K P Johnson ◽

B R Brooks ◽

C C Ford ◽

A Goodman ◽

J Guarnaccia ◽

...

Keyword(s):

Multiple Sclerosis ◽

Glatiramer Acetate ◽

Relapse Rate ◽

Open Label ◽

Double Blind ◽

Open Label Study ◽

Label Study ◽

Open Label Phase ◽

Multiple Sclerosis Patients ◽

To Receive

In a randomized, placebo-controlled, double-blind study, glatiramer acetate (Copaxone®) reduced the relapse rate and slowed accumulation of disability for patients with relapsing-remitting multiple sclerosis. Of the original 251 patients randomized to receive glatiramer acetate or placebo, 208 chose to continue in an open-label study with all patients receiving active drug. The majority of the original double-blind cohort continues to receive glatiramer acetate by daily subcutaneous injection and are evaluated at 6-month intervals and during suspected relapse. The data reported here are from approximately 6 years of organized evaluation, including the double-blind phase of up to 35 months and the open-label phase of over 36 months. Daily subcutaneous injections of 20 mg glatiramer acetate were well tolerated. The mean annual relapse rate of the patients who received glatiramer acetate since randomization and continued into the open-label study was 0.42 (95% confidence interval (CI), CI=0.34-0.51). The rate per year has continued to drop and for the sixth year is 0.23. Of the group who have received glatiramer acetate without interruption for 5 or more years, 69.3% were neurologically unchanged or have improved from baseline by at least one step on the Expanded Disability Status Scale (EDSS). Patients who left the open-label phase were surveyed by questionnaire. The majority responded, providing information about their current status and reasons for dropping out. This study demonstrates the sustained efficacy of glatiramer acetate in reducing the relapse rate and in slowing the accumulation of disability in patients with relapsing forms of multiple sclerosis.

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