Every-Other-Day Dosing of Glatiramer Acetate Reduces Adverse Reactions With Comparable Efficacy to Daily Dosing: Presented at WCTRMS
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Every-Other-Day Dosing of Glatiramer Acetate Reduces Adverse Reactions With Comparable Efficacy to Daily Dosing: Presented at WCTRMS

By Louise Gagnon

MONTREAL -- September 21, 2008 -- Subcutaneous glatiramer acetate can be administered every other day with comparable efficacy to that of daily dosing in patients with relapsing remitting multiple sclerosis (RRMS), according to research from a 4-year study presented here at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRMS).

Patients who receive daily injections of glatiramer acetate often develop lipotrophy and injection-site reactions, explained lead investigator Omar Khan, MD, Wayne State University School of Medicine, Detroit, Michigan, United States. There was interest, therefore, in testing the effects of another treatment regimen, apart from 20 mg daily, with the goal of minimising adverse events, he said at a poster session here on September 20.

The primary endpoint of this study was based on a composite of clinical, magnetic resonance imaging, and immunological outcomes.

A total of 30 treatment-naïve patients were randomised to a standard daily 20-mg dose of glatiramer acetate or the same dose every other day. Patients in the 2 treatment groups were matched for age, duration of disease, Extended Disability Status Score (EDSS), relapse rate, T2-weighted lesions, and gadolinium-enhancing lesions.

After prospective examination at 2 years, patients in each treatment arm had the choice of continuing their regimen or switching to the other regimen. Patients were then followed for another 2 years. The EDSS was measured every 6 months by a rater who was blinded to the study arms.

At 2 years, all patients in the daily-dose arm chose to modify therapy to every-other-day dosing.

Investigators found that there were no differences in progression of illness, change in T2-weighted lesion volume, or gadolinium-enhancing lesions between the 2 groups at the 2-year evaluation.

After 4 years, investigators observed comparable efficacy on all measures between the crossover arm and the arm in which patients maintained every-other-day therapy for 4 years.

A larger study is planned that will examine 3 possible injection regimens of glatiramer acetate, including a daily dose, an every-other-day dose, and a weekly dose, said Dr. Khan, noting that future research will not be funded by any pharmaceutical manufacturer.

"The goal is to find the optimal dose of the drug," he concluded.

[Presentation title: Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis. Abstract 902]

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