title: Time course of glatiramer acetate efficacy in patients with RRMS in the GALA study.
abstract: OBJECTIVE
  To determine the time to efficacy onset of glatiramer acetate (GA) 40 mg/mL 3-times-weekly formulation (GA40).
  
  
  METHODS
  This post hoc analysis of data from the 1-year, double-blind, placebo-controlled phase of the Glatiramer Acetate Low-Frequency Administration study (NCT01067521) of GA40 in patients with relapsing-remitting MS (RRMS) sought to determine the timing of efficacy onset using a novel data-censoring approach.
  
  
  RESULTS
  Compared with placebo-treated patients, those receiving GA40 exhibited a >30% reduction in the accumulated annualized relapse rate (ARR) within 2 months of initiating treatment and generally sustained this treatment difference during the 1-year study. Similarly, the proportion of GA40-treated patients who remained relapse-free was distinctly greater by month 2 and continued to increase up to a 10.8% difference at the end of the study. In addition, GA40 treatment was associated with a significant reduction in the number of gadolinium-enhancing T1 lesions and new/enlarging T2 lesions by month 6, with full treatment effect observed after 1 year.
  
  
  CONCLUSIONS
  GA40 contributes to efficacy within 2 months of the start of treatment in patients with RRMS. These results are consistent with the observed time to efficacy onset for patients treated with GA 20 mg/mL daily in previous randomized, placebo-controlled clinical trials.
  
  
  METHODS
  This study provides Class II evidence that for patients with RRMS, a 3-times-weekly formulation of GA 40 mg/mL leads to a >30% reduction in the ARR within 2 months.
authors.affiliation: Teva Pharmaceutical Industries (M.D.D., J.R.S., V.K.), Frazer, PA; Teva Pharmaceutical Industries (N.A.), Netanya, Israel; and Heinrich-Heine Universität Düsseldorf (V.K.), Germany.
authors.forename: Mat D
authors.initials: MD
authors.lastname: Davis
authors.affiliation: Teva Pharmaceutical Industries (M.D.D., J.R.S., V.K.), Frazer, PA; Teva Pharmaceutical Industries (N.A.), Netanya, Israel; and Heinrich-Heine Universität Düsseldorf (V.K.), Germany.
authors.forename: Natalia
authors.initials: N
authors.lastname: Ashtamker
authors.affiliation: Teva Pharmaceutical Industries (M.D.D., J.R.S., V.K.), Frazer, PA; Teva Pharmaceutical Industries (N.A.), Netanya, Israel; and Heinrich-Heine Universität Düsseldorf (V.K.), Germany.
authors.forename: Joshua R
authors.initials: JR
authors.lastname: Steinerman
authors.affiliation: Teva Pharmaceutical Industries (M.D.D., J.R.S., V.K.), Frazer, PA; Teva Pharmaceutical Industries (N.A.), Netanya, Israel; and Heinrich-Heine Universität Düsseldorf (V.K.), Germany.
authors.forename: Volker
authors.initials: V
authors.lastname: Knappertz