Abstract Details

Title Five Years Analysis of anti-Glatiramer Acetate (GA) Antibodies in Patients with Relapsing Remitting Multiple Sclerosis Treated with GA Depot

Topic Multiple Sclerosis

Presentation(s) P5 - Poster Session 5 (11:45 AM-12:45 PM)

Poster/Presentation
Number 12-010

Objective Correlation of long-term assessment of anti-GA Antibodies in the sera of patients treated with GA Depot to the safety and efficacy of GA Depot treatment.

Background GA Depot consists of extended-release microspheres containing GA, administered intramuscularly once every 28 days. GA Depot activity was evaluated in a long-term phase IIa study in relapsing remitting MS (RRMS) patients. During the study, serum samples from patients were collected and analyzed for anti-GA Abs.

Design/Methods Main eligibility criteria: age 18-70 years, diagnosis of RRMS and treatment with Copaxone® for ≥12 months prior to enrollment. Patients received monthly GA Depot at doses of 80mg or 40mg in the core study (one year) and 40mg in the study extension for a total of 244 weeks. Anti-GA Ab levels were determined using ELISA. Correlation assessment between Ab levels and clinical safety and efficacy was performed using descriptive statistics.

Results Average anti-GA Ab levels at study baseline and one month following the first injection were similar (Binding Index – BI- of 5.92 +/- 1.13 and 5.57 +/- 1.25 respectively). Levels declined from week 12, reaching BI of 2.80 +/- 0.57 at week 100. This trend was sustained until week 244 (BI of 2.30 +/- 0.60). The efficacy of GA Depot was similar throughout the study (yearly NEDA-3 for the Per Protocol population was 84.6% for the core study, 81.8% for the 2^nd year of the study and 90% for years 3, 4 and 5). The rate of AEs, injection site reactions and SAEs was continuously reduced from the core study throughout the extension and confirmed a good safety profile.

Conclusions Anti-GA Ab levels in GA Depot treated patients followed the same trend as previously reported for GA (Copaxone^©) treated patients. No correlation was found between the levels of anti-GA Abs and the safety and efficacy clinical outcomes in the study population.

Authors/Disclosures
Ehud Marom PRESENTER	Mr. Marom has received personal compensation for serving as an employee of Mapi Pharma. Mr. Marom has received personal compensation in the range of $500,000-$999,999 for serving as an officer or member of the Board of Directors for Mapi Pharma. Mr. Marom has stock in Mapi Pharma. Mr. Marom has received intellectual property interests from a discovery or technology relating to health care.
Shlomo Flechter, MD, FAAN (Outpatient Clinic)	Dr. Flechter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Flechter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mapi Pharma.
Ariel L. Miller, MD, PhD	Dr. Miller has nothing to disclose.
Laura Popper, MD (Mapi Pharma Ltd.)	Dr. Popper has received personal compensation for serving as an employee of Mapi Pharma.
Nadav Bleich Kimelman	Nadav Bleich Kimelman has nothing to disclose.
Shai Rubnov	Shai Rubnov has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Mapi pharma.
Uri Danon	Uri Danon has received personal compensation for serving as an employee of Mapi harma.
Ron E. Milo, MD, FAAN (Barzilai Medical Center)	Dr. Milo has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck KGaA . Dr. Milo has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck-Serono. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Milo has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Brystol-Myers-Squibb . Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medison. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neopharm. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Milo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Brystol-Myers-Squibb.
Joab Chapman, MD, PhD (Sheba Medical Center)	Dr. Chapman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mapi Pharma. Dr. Chapman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Dr. Chapman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merk Serono. The institution of Dr. Chapman has received research support from Ministry Of Industry.
Alla Shifrin, MD (Rambam Medical Center)	Dr. Shifrin has nothing to disclose.
Ronit Gilad	Ms. Gilad has nothing to disclose.
	No disclosure on file
	No disclosure on file
Dimitrios Karussis, MD, PhD (Hadassah HMO)	Prof. Karussis has nothing to disclose.
Arnon Karni, MD, PhD (Tel Aviv Sourasky medical center)	Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neopharm. Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Prof. Karni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. The institution of Prof. Karni has received research support from Medison. The institution of Prof. Karni has received research support from BMS. The institution of Prof. Karni has received research support from Novartis.

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