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Study: Aubagio is Effective and Safe in Treating RRMS

October 15, 2015

A Phase III study showed that the oral immune modulator Aubagio is a safe and effective treatment for relapsing-remitting multiple sclerosis. Paul O’Connor, MD of the University of Toronto reported that the drug provided a 31% relative risk reduction in annualized relapse rate compared with placebo with no major safety concerns.

This could represent a potential first-line therapy for this patient population, something that has been a need for a while. Teriflunomide blocks the synthesis of pyrimidines, and joins the growing list of cell cycle-inhibiting drugs in the pipeline for MS treatment. The drug inhibits replication and function of activated T cells, but has no effect on resting T cells.

The 1,000+ patients in this trial had mild disability and an EDSS score of 5 or less, with at least one relapse over the previous year or two relapses over the previous two years. Patients were randomized evenly to placebo or teriflunomide at 7 mg or 14 mg once a day.

At the end of the 2 year 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%. Dr. O’Connor said that the risk reduction was a huge plus.

Some side effects were nausea, diarrhea and slight hair thinning, but other than that, Aubagio was ruled a safe and effective therapy for patients with RRMS.