Abstract
OBJECTIVE: To evaluate the timing of efficacy onset of glatiramer acetate 40 mg/mL three-times weekly (GA40) during the 1-year placebo-controlled phase of the GALA study. BACKGROUND: Patients eligible for the GALA study included those who were GA treatment-naive, and were relapse-free for ≥30 days and treatment-free for >2 months, prior to screening. GA40 significantly reduced annualized relapse rate (ARR), time to first relapse, and cumulative number of enhancing T1 and new/enlarging T2 lesions in these patients. DESIGN/METHODS: Baseline-adjusted percent reduction in annualized relapse rate and percent of relapse-free patients were calculated to examine treatment effect over time. Reductions in the numbers of enhancing T1 and new/enlarging T2 lesions were analyzed separately at Months 6 and 12. RESULTS: Baseline demographics showed no significant differences between the two groups. Compared with placebo-treated patients, GA40-treated patients first exhibited >30[percnt] ARR reduction 47 days after initiation of treatment. GA40-treated patients exhibited consistent, low ARR compared with placebo, with ARR reduction of 29.9[percnt] at 12 weeks (P=.046), 24.7[percnt] at 24 weeks (P=.023), 31.9[percnt] at 36 weeks (P<.001), and 34.2[percnt] at 48 weeks (P<.001). The proportions of relapse-free subjects were also different between treatment groups, with 92.8[percnt] of GA40 vs 88.7[percnt] of placebo patients being relapse-free at 12 weeks, 84.4[percnt] vs 79.5[percnt] at 24 weeks, 79.8[percnt] vs 71.7[percnt] at 36 weeks, and 77.3[percnt] vs 67.0[percnt] at 48 weeks. GA40-treated patients demonstrated a 38.0[percnt] reduction in enhancing T1 lesions (P=.001) and a 24.2[percnt] reduction in new/enlarging T2 lesions (P=.005) compared with placebo at 6 months. CONCLUSION: GA40 demonstrated significant efficacy in reducing relapses within 2 months of treatment initiation and sustained this effect over the length of the trial. GA40-treated patients exhibited significant reductions in both enhancing T1 and new/enlarging T2 lesions as early as the first post-treatment MRI scan at 6 months.
Disclosure: Dr. Davis has received personal compensation for activities with Teva Pharmaceuticals as an employee. Dr. Ashtamker has received personal compensation for activities with Teva as an employee. Dr. Steinerman has received personal compensation for activities with Teva Neuroscience as an employee. Dr. Knappertz has received personal compensation for activities with Teva Neuroscience as an employee.
Thursday, April 21 2016, 3:30 pm-5:30 pm
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