How can Aubagio (teriflunomide) help people with multiple sclerosis (MS)?

The oral immune modulator teriflunomide provided a 31% relative risk reduction in annualized relapse rate compared with placebo with no major safety concerns in a phase III trial called TEMSO.

Teriflunomide joins the growing list of cell cycle ­inhibiting drugs in the pipeline for multiple sclerosis (MS) treatment. The drug inhibits replication and function of activated T cells, but has no effect on resting T cells.

The 1088 participants in the TEMSO trial had mild disability with an Expanded Disability Status Scale (EDSS) score of 5 or less, with at least one relapse over the previous year or two relapses over the previous two years. They were randomized evenly to placebo or teriflunomide at 7 milligrams or 14 milligrams once a day.

At the end of the 108­week trial, the annualized relapse rate was equivalent in the two active treatment arms, 0.37, compared with 0.54 for the placebo arm, a relative risk reduction of 31%. The risk of disability progression was also reduced by treatment. The proportion of participants with 12­week confirmed disability progression was 27% for placebo, 22% for low­dose and 20% for high­dose teriflunomide.

The rate of adverse events was the same among all groups, as was the rate for serious adverse events, and there were no deaths.

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