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Glatiramer acetate

(Copaxone®)

Copaxone®

Drug updated on 11/1/2024

Dosage FormInjection (subcutaneous; 20 mg/mL, 40 mg/mL)
Drug ClassImmunomodulator
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
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  • This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
  • Glatiramer acetate (GA) shows no moderate or high-certainty evidence of effectiveness in reducing relapses or disability worsening in multiple sclerosis (MS) over periods of 12, 24, or 36 months compared to placebo, especially in relapsing-remitting MS (RRMS) and progressive MS (PMS) populations.
  • GA significantly reduces the number and volume of T1 hypointense lesions in adult MS patients, with a mean difference of -1.3 in lesion count and -363.1 in lesion volume, indicating a measurable effect on imaging markers of disease activity in MS.
  • Comparative evidence indicates GA’s moderate effectiveness in reducing relapse rates over 24 months (RR (relative risk) 0.84) but suggests that alternative therapies, including natalizumab, cladribine, alemtuzumab, and fingolimod, demonstrate higher efficacy in relapse reduction, with risk ratios ranging from 0.48 to 0.62.
  • GA is associated with common adverse events, including cutaneous reactions (32.75%), hepatic side effects (13.54%), allergic reactions (8.3%), and neurological side effects (5.68%). However, no moderate or high-certainty evidence indicates an increased rate of serious adverse events (SAEs) compared to placebo.
  • GA moderately increases the likelihood of treatment discontinuation due to adverse events (OR (odds ratio) 3.98, moderate-certainty evidence), with many injection-related reactions linked to immune and hypersensitivity responses, potentially associated with GA’s immunomodulatory action.
  • The majority of studies on glatiramer acetate (GA) involved multiple sclerosis (MS) patients, with a high proportion of female participants (68.6% female, 31.4% male in one study), primarily evaluating GA in relapsing-remitting MS (RRMS) and progressive MS (PMS). Additionally, some studies investigated off-label uses in neurodegenerative conditions such as Alzheimer's disease and amyotrophic lateral sclerosis, though high risk of bias due to sponsor involvement was noted in data management and analysis.