Background: Copaxone
Glatiramer acetate (GA), marketed as Copaxone by pharmaceutical company Teva Pharmaceuticals, is one of the most commonly prescribed drugs to treat relapsing-remitting multiple sclerosis (MS) in Canada. Copaxone has ‘immunomodulatory’ effects, meaning it has the ability to alter the immune system which is thought to mistakenly attack myelin – the protective insulation found wrapped around nerve fibers in the central nervous system– in people with MS.
Glatiramer acetate is taken to reduce the frequency of relapses, and is also prescribed for patients who have experienced a single clinical episode and have MRI features consistent with MS (Read more about glatiramer acetate on our website).
Individuals on glatiramer acetate typically undergo once-a-day under the skin injections at a dose of 20mg per injection. Earlier this month, Teva Pharmaceuticals announced results of a study which showed that twice the standard dose of glatiramer acetate administered less frequently throughout the week is safe and can lead to beneficial outcomes in people with MS.
The GALA Study:
The Glatiramer Acetate Low-frequency Administration (GALA) study was a phase III clinical trial that assessed the efficacy (ability to produce a beneficial effect) and safety of glatiramer acetate at a dose of 40mg, administered three times per week over 12 months. This dosing schedule was selected because it equates to the total weekly dose following 20mg once a day (120mg/week).
The GALA study was conducted in 142 sites across 17 countries and involved 1,404 participants. Researchers who led the study observed number of relapses as well as disease activity seen on MRI in people with relapsing remitting MS who received glatiramer acetate treatment versus those treated with placebo (a mock drug).
What they found:
Results of the study showed that treatment with glatiramer acetate, at a dose of 40mg three times per week, led to a 34% reduction in number of relapses over 12 months compared to placebo. Researchers also reported a 44.8% decrease in disease activity observed on MRI. Moreover, taking glatiramer acetate at twice the standard dose three times a week was shown to be just as safe as the standard dose taken daily.
Relevance:
People living with MS face many challenges. Among these, staying on top of a rigorous treatment regimen is daunting. This study illustrates that taking glatiramer acetate, or Copaxone, at 40mg three times a week is effective in reducing MS disease, and appears to be safe and well-tolerated by the human body. This study provides promising evidence of a safe and effective alternative treatment schedule that may help to lessen the burden of glatiramer acetate injections in people with relapsing-remitting MS.
Sources:
Khan O et al. Three times weekly glatiramer acetate in
relapsing-remitting multiple sclerosis. Annals of
Neurology 2013 June 28 [Epub ahead of print]