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. 2017 Feb 8;4(2):e327.
doi: 10.1212/NXI.0000000000000327. eCollection 2017 Mar.

Time course of glatiramer acetate efficacy in patients with RRMS in the GALA study

Mat D Davis  1 , Natalia Ashtamker  1 , Joshua R Steinerman  1 , Volker Knappertz  1
Affiliations

Time course of glatiramer acetate efficacy in patients with RRMS in the GALA study

Mat D Davis et al. Neurol Neuroimmunol Neuroinflamm. .

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.

Classification of evidence: 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.

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Figures

Figure 1
Figure 1. GALA study design
*Only clinical visits involving complete neurologic and physical examination are represented in this figure. GA40 = glatiramer acetate 40 mg/mL 3-times-weekly SC injection; R = randomization.
Figure 2
Figure 2. Accumulating annualized relapse rate
Accumulating ARR is not adjusted for baseline characteristics. ARR = annualized relapse rate; GA40 = glatiramer acetate 40 mg/mL 3-times-weekly SC injection.
Figure 3
Figure 3. Proportion of patients with a confirmed relapse in the GALA study
GA40 = glatiramer acetate 40 mg/mL 3-times-weekly SC injection.
Figure 4
Figure 4. MRI lesion activity in the GALA study
GA40 = glatiramer acetate 40 mg/mL 3-times-weekly SC injection; GdE = gadolinium enhancing; SE = standard error.
See this image and copyright information in PMC

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