Thrice-Weekly Glatiramer Acetate for Relapsing Forms of Multiple Sclerosis:

Findings from the GALA Study

Fred D. Lublin, MD Saunders Family Professor

of NeurologyDirector, The Corinne Goldsmith

Dickinson Center for Multiple Sclerosis

The Icahn School of MedicineNew York, NY

Krzysztof Selmaj, MD, PhD

Professor of NeurologyChair, Department of Neurology

Medical University of LodzLodz, 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

12Khan O, et al. Ann Neurol. 2013;73:705-713.

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GALA: Primary Efficacy of Glatiramer Acetate TIW 34% Relative Reduction in Relapse Rate

Khan O, et al. Ann Neurol. 2013;73:705-713.

P <.0001

Placebo

Glatiramer acetate 40 mg TIW

Relative reduction in new/newly enlarging T2 lesions at months 6 and 12

34.7%

44.8% Relative reduction in Gd-enhancing lesions on

T1-weighted imaging at months 6 and 12

9.4% Relative percentage brain volume change from

baseline to month 12

GALA: Secondary EndpointsGlatiramer Acetate TIW vs Placebo

Khan O, et al. Ann Neurol. 2013;73:705-713.

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