Thrice-Weekly Glatiramer Acetate for Relapsing Forms of Multiple Sclerosis: Findings from the GALA Study Fred D. Lublin, MD Saunders Family Professor of.

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Presentation transcript:

Thrice-Weekly Glatiramer Acetate for Relapsing Forms of Multiple Sclerosis: Findings from the GALA Study Fred D. Lublin, MD Saunders Family Professor of Neurology Director, The Corinne Goldsmith Dickinson Center for Multiple Sclerosis The Icahn School of Medicine New York, NY Krzysztof Selmaj, MD, PhD Professor of Neurology Chair, Department of Neurology Medical University of Lodz Lodz, Poland

GALA: Study Design Randomized, double-blind, placebo-controlled, parallel-group, phase III trial Two study arms –Glatiramer acetate 40 mg TIW (n = 943) –Placebo (n = 461) Primary endpoint –Annualized relapse rate at 1 year Secondary endpoints –Cumulative number of new/newly enlarging T2 lesions at months 6 and 12 –Cumulative number of Gd-enhancing lesions on T1- weighted imaging at months 6 and 12 –Percentage brain volume change from baseline to month 12 Khan O, et al. Ann Neurol. 2013;73:

Annualized Relapse Rate GALA: Primary Efficacy of Glatiramer Acetate TIW 34% Relative Reduction in Relapse Rate Khan O, et al. Ann Neurol. 2013;73: P <.0001 Placebo Glatiramer acetate 40 mg TIW

Relative reduction in new/newly enlarging T2 lesions at months 6 and %  44.8%  Relative reduction in Gd-enhancing lesions on T1-weighted imaging at months 6 and %  Relative percentage brain volume change from baseline to month 12 GALA: Secondary Endpoints Glatiramer Acetate TIW vs Placebo Khan O, et al. Ann Neurol. 2013;73:

Clinical Use of Glatiramer Acetate 40 mg TIW In general, fewer injections is more convenient for and acceptable to patients Thrice-weekly dosing may improve adherence in patients having difficulty with daily injections Safety profile of thrice-weekly dosing is similar to that observed with once-daily dosing –GALA study not long enough to evaluate dose-effect on subcutaneous atrophy Glatiramer acetate 40 mg TIW is approved for patients with relapsing forms of MS