Genzyme announced positive top-line results from the TOPIC trial for Aubagio (teriflunomide) designed to assess whether early initiation of Aubagio in patients who experienced their first neurological symptoms consistent with Clinically Isolated Syndrome (CIS) can prevent or delay conversion to clinically definite multiple sclerosis (CDMS). Aubagio is an immunomodulator with anti-inflammatory properties.

This double-blind, multi-center trial enrolled 618 patients who experienced a first acute or sub-acute, well-defined neurological event consistent with demyelination, as well as onset of multiple sclerosis (MS) symptoms within 90 days of randomization, and MRI scan showing two or more T2 lesions characteristic of MS. The trial compared treatment with either 7 mg or 14 mg of once-daily, oral Aubagio against placebo.

In the TOPIC trial, patients receiving Aubagio 7mg and 14mg were significantly less likely to develop CDMS, defined as occurrence of a second clinical attack, the primary endpoint, as compared to placebo. In patients who received Aubagio 7mg, a 37% reduction in risk of conversion to CDMS was observed over the two-year study period, compared to placebo (P=0.0271). In patients who received Aubagio 14mg, a 43% reduction in risk of conversion to CDMS was observed over the two-year study period, compared to placebo (P=0.0087).

Aubagio is a once daily oral treatment already indicated for patients with relapsing forms of MS. 


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