Efficacy and safety of a three-times weekly dosing regimen of glatiramer acetate in relapsing-remitting multiple sclerosis patients: 3-year results of the Glatiramer Acetate Low-frequency Administration (GALA) open-label extension study (P7.273)

OBJECTIVE: To evaluate the efficacy and safety of glatiramer acetate 40 mg/mL three-times weekly (GA40) over 36 months during the placebo-controlled (PC) and open-label (OL) extension phases of the GALA study. BACKGROUND: In the PC phase of the GALA study, GA40 significantly reduced annualized relapse rate (ARR), cumulative number of enhancing T1, and new/enlarging T2 lesions. Participants who completed the 12 month PC phase were eligible to receive OL GA40 treatment. DESIGN/METHODS: 97.2[percnt] of PC phase completers consented to enter the OL extension. Early start (ES) patients (n=834) received GA40 for 36 months. Delayed start (DS) patients (n=419) switched from placebo to GA40 at Month 12. RESULTS: 716 ES (85.9[percnt]) and 325 DS (77.6[percnt]) patients completed 36 months of treatment. The adjusted mean ARR was significantly lower for ES versus DS patients over 36 months (0.23 vs 0.30, risk ratio [RR]=0.770; P =0.0052). Significantly fewer cumulative gadolinium-enhancing T1 and new/enlarging T2 lesions were observed in ES versus DS patients over 36 months (RR=0.660, P =0.0005 for T1; RR=0.680, P P =0.0260). Rates of adverse events (AEs) and serious AEs were lower in the OL extension compared with the PC phase of the study. No new common AEs were identified. AEs were consistent with the GA safety profile. CONCLUSION: Early treatment with GA40 resulted in sustained reductions in ARR, lesion activity, and evolution of active lesions to chronic black holes over 36 months. No new safety signal was identified, and AEs were consistent with the well-established GA safety profile. Disclosure: Dr. Khan has received personal compensation for activities with Biogen Idec, Genzyme, Novartis, and Teva Neuroscience. Dr. Khan has received research funding from National Institutes of Health, National Institute of Neurological Disorders and Stroke, Nati Dr. Rieckmann has received personal compensation for activities with Bayer Pharmaceuticals Corp., Biogen Idec, Boehringer Ingelheim Pharmaceuticals Inc., Novartis, Merck Serono, Teva Neuroscience and Genzyme Corporation as a speaker. Dr. Boyko has received personal compensation for activities with Bayer Schering, Merck Serono, Teva, Novartis, Biogen Idec, Nycomed, Genzyme, and Sanofi-Aventis as a consultant and/or speaker. Dr. Selmaj has received personal compensation for activities with Genzyme Corporation, Novartis, Ono Pharmaceutical, Roche Diagnostics Corporation, Synthon, Teva Neuroscience, and Biogen Idec. as a consultant and/or speaker. Dr. Ashtamker has received personal compensation for activities with Teva Neuroscience as an employee. Dr. Davis has received personal compensation for activities with Teva as an employee. Dr. Kolodny has received personal compensation for activities with Teva Neuroscience as an employee. Dr. Zivadinov has received personal compensation for activities with Teva Neuroscience, Biogen Idec, EMD Serono, Novartis, Claret Medical Inc., and Genzyme Corporation as a speaker and/or consultant.