Abstract Details

Title Reduction of RRMS Disease Activity with a Three Times Weekly Regimen of Glatiramer Acetate 40 mg Injection: A Post Hoc Analysis from the GALA Study

Topic MS and Related Diseases

Presentation(s) P07 - (-)

Poster/Presentation
Number 090

Objective

Background BACKGROUND: The Glatiramer Acetate Low Frequency Administration Study (GALA) demonstrated that GA 40mg t.i.w. significantly reduced annualized relapse rate and the cumulative number of new/enlarging T2 lesions and GdE lesions at 12 months versus placebo in patients with RRMS. This post hoc analysis examined the effects of the 40mg regimen in reducing disease activity.

Design/Methods DESIGN/METHODS: In GALA, 1404 patients aged 18-55 years with RRMS (revised McDonald criteria, 2005), an Expanded Disability Status Scale (EDSS) score of ?5.5, and relapse free for ?30 days at screening were randomized 2:1 to receive GA 40mg t.i.w. or placebo. Post hoc assessments included the following analyses: rates of being disease free (no relapses, no EDSS progression, no GdE or T2 lesions at months 6 or 12), clinical disease free (no relapses, no EDSS progression), MRI disease free (no GdE, no T2 lesions at months 6 and 12), and disease activity free (no relapses, no GdE or T2 lesions at months 6 or 12), Descriptive and inferential statistics analyses were performed on each assessment. EDSS at baseline, log of the number of relapses in the prior 2 years, baseline T1 lesion number, and country were covariates depending on the assessment.

Results RESULTS: Results for 1325 patients (GA 40mg = 884; placebo = 441) were available for post hoc analysis. A significantly greater proportion of patients receiving GA were disease free (23.3% vs 15.2%; p=0.0002), clinical disease free (74.7% vs 63.9%; p<0.0001), MRI disease free (29.8% vs 21.5%; p=0.0010), and disease activity free (24.1% vs 15.6%; p=0.0001) compared with patients receiving placebo.

Conclusions CONCLUSIONS: GA 40mg administered t.i.w. significantly reduced measures of disease activity in patients with RRMS compared with placebo.

Authors/Disclosures
Peter Rieckmann, MD, FAAN (Direktor Neurologische Klinik) PRESENTER	No disclosure on file
	No disclosure on file
Douglas L. Arnold, MD, FAAN (Montreal Neurological Institute, McGill Univ)	Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Frequency Therapeutics. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Xfacto communications. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Find therapeutics. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Idorsia. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kiniksa. Dr. Arnold has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Clario.
	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.
Omar A. Khan, MD, PhD (Dept of Neuro/Wayne State Univ Sch of Med)	No disclosure on file

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