Abstract Details

Title A Multinational, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study To Assess the Efficacy, Safety, and Tolerability of Glatiramer Acetate 40 mg Injection Three Times a Week in Subjects with RRMS: Efficacy and Safety Results of the GALA Study

Topic MS and Related Diseases

Presentation(s) S01 - (-)

Poster/Presentation
Number 005

Background The 20 mg/day regimen for GA reduces relapse frequency and delays disability progression in patients with RRMS. The Glatiramer Acetate Low Frequency Administration Study (GALA) study was conducted to investigate the efficacy and safety of GA 40 mg subcutaneous (s.c.) injection, administered t.i.w.

Objective

Design/Methods RRMS patients (N=1404) were randomized in a 2:1 ratio to receive GA (n=943) 40mg t.i.w. s.c. injection or matched placebo (n=461) for 12 months. Patients underwent neurological examinations at screening, baseline, 1,3,6,9, and 12 months or at early discontinuation. Brain MRI scans were obtained at baseline and months 6 and 12. Annualized relapse rate (ARR) was the primary endpoint. Secondary endpoints included MRI parameters, cumulative number of new/enlarging T2 lesions and gadolinium enhancing (GdE) lesions, and the percent of brain volume change from baseline to month 12.

Results 8.9% GA and 6.7% placebo patients discontinued from the study. There were no significant differences between the two groups in terms of baseline characteristics. Both groups had pronounced T2 lesion load at study entry (19.7 ml±20.7 and 17.4 ml±17.4 for GA and placebo groups, respectively). ARR was reduced by 34.4% in the GA group versus placebo (p<0.0001). At 12 months, the cumulative number of new/enlarging T2 lesions (34.7% reduction, p<0.0001) and GdE lesions (44.8% reduction, p<0.0001) were significantly lower in GA patients. No significant difference in percent change of brain volume was observed between GA and placebo at 12 months.

Conclusions Glatiramer acetate at 40mg t.i.w. significantly reduced the ARR as well as the cumulative number of new/enlarging T2 and GdE lesions and may provide a potential alternative therapeutic option of using a higher dose of GA at a reduced injection frequency.

Authors/Disclosures
Omar A. Khan, MD, PhD (Dept of Neuro/Wayne State Univ Sch of Med) PRESENTER	No disclosure on file
Peter Rieckmann, MD, FAAN (Direktor Neurologische Klinik)	No disclosure on file
	No disclosure on file
	No disclosure on file
Robert Zivadinov, MD, PhD, FAAN (Buffalo Neuroimaging Analysis Center)	The institution of Dr. Zivadinov has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. The institution of Dr. Zivadinov has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Omnicuris. The institution of Dr. Zivadinov has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Myrobalan. Dr. Zivadinov has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Zivadinov has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Zivadinov has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bristol Myers Squibb. The institution of Dr. Zivadinov has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen.
	No disclosure on file

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