Aubagio – How Well It Works

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The effectiveness of Aubagio was tested in two randomized, double-blind, placebo-controlled studies in people with relapsing forms of MS.

 

Aubagio Results of Study 1

Study 1, which lasted 108 weeks, included 1,088 people who had had at least 1 exacerbation in the year before the study or at least 2 exacerbations over the 2 years before the study. Participants were randomized (assigned randomly or by chance) to receive Aubagio 7 mg (n=366), Aubagio 14 mg (n=359), or placebo (n=363).  The primary efficacy outcome (the key measure that was used to test the effectiveness of the medication) was annual rate of relapse.

People who received either dose of Aubagio had a significantly lower annual rate of relapse compared with placebo. Aubagio 14 mg also resulted in a significant increase in the time it took for disability to progress compared with placebo. Additionally, people who received either dose of Aubagio had a significantly lower increase in total brain lesion volume compared with placebo. The table and figure below highlight key results from the study.

Study 1 results: Aubagio versus placebo

Outcome

Aubagio 7 mg (n=365)

Significance vs placebo

Aubagio 14 mg (n=358)

Significance vs placebo

Placebo (n=363)

Annual rate of relapse 0.37 P=0.0002 0.37 P=0.0005 0.54
% Risk reduction vs placebo 31% 31%
% Patients with disability progression at 108 weeks 21.7% NS 20.2% P=0.028 27.3%
% Change in lesion volume from baseline by MRI (median) 0.755 P=0.0317 0.345 P=0.0003 1.127
No. of Gd-enhancing lesions per scan by MRI (mean) 0.570 P<0.0001 0.261 P<0.0001 1.331

 

Aubagio Results of Study 2

Aubagio was tested in a second study that included 179 people with relapsing forms of MS. Participants were randomized to Aubagio 7 mg (n=61), Aubagio 14 mg (n=57), or placebo (n=61). Outcomes in this study were measured using MRI, with the primary efficacy outcome being the average number of unique active brain lesions during treatment. People who received either dose of Aubagio had a significantly lower average number of unique active lesions compared with placebo.

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