Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 20 mg/mL, 40 mg/mL) |
Drug Class | Acetate salts of synthetic polypeptides |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
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Summary
- Copaxone (glatiramer acetate) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
- This summary is based on the review of three systematic reviews/meta-analyses. [1-4]
- Glatiramer acetate (GA) did not outperform alemtuzumab, mitoxantrone, natalizumab, and fingolimod in reducing relapses or preventing disability worsening within the first 24 months in patients with relapsing-remitting multiple sclerosis (RRMS).
- GA demonstrated a small to moderate positive effect on cognitive test performance in RRMS patients, which was similar to β-interferon but not statistically superior to other disease-modifying treatments (DMTs).
- GA has shown potential neuroprotective effects in neurodegenerative diseases, with some evidence suggesting it mitigates MS-associated cognitive decline, though further large-scale clinical trials are needed to confirm these findings.
- Almost all agents, including GA, exhibited higher withdrawal rates due to adverse events compared to placebo, but specific adverse event rates for GA were not detailed.
- No specific safety concerns or adverse effects of GA were reported in the context of its neuroprotective uses, and safety data specific to GA was not detailed in the reviewed studies.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Copaxone (glatiramer acetate) Prescribing Information. | 2023 | Teva Neuroscience, Inc., Parsippany, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis. | 2024 | The Cochrane Database of Systematic Reviews |
Glatiramer acetate immunomodulation: evidence of neuroprotection and cognitive preservation. | 2022 | Cells |
False-positive test results in diagnosing allergy to glatiramer acetate: case report and a systematic literature review. | 2020 | Immunity, Inflammation and Disease |
Disease-modifying treatments and cognition in relapsing-remitting multiple sclerosis: a meta-analysis. | 2020 | Neurology |