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Teriflunomide (Aubagio) Reduces Risk of Relapse in Multiple Sclerosis Study
Positive data have been reported from the TOPIC trial of once-daily oral teriflunomide (Aubagio, Genzyme). The new data, presented Oct. 3 at the 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS), include the following:
- Teriflunomide 14 mg significantly reduced the risk of a new clinical relapse or magnetic resonance imaging (MRI) lesion over the 2-year study period. There was a 35% reduction among patients who received teriflunomide 14 mg compared with placebo (P = 0.0003).
- As measured by MRI over the 2-year study period, there was a 5% increase in total lesion volume among patients treated with teriflunomide 14 mg compared with a 28% increase among patients given placebo (P = 0.0374). In addition, there was a 59% reduction in gadolinium-enhancing T1 lesions among patients treated with teriflunomide 14 mg compared with the placebo group (P = 0.0008).
Similar results were observed for a 7-mg dose of teriflunomide, although the effects did not achieve statistical significance on some endpoints.
The TOPIC trial was designed to assess whether early initiation of teriflunomide in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack, i.e., conversion to clinically definite multiple sclerosis (CDMS).
Patients receiving teriflunomide 14 mg and 7 mg in the TOPIC trial were significantly less likely than those given placebo to develop CDMS, the study’s primary endpoint. Compared with placebo, teriflunomide 14 mg reduced the risk of conversion to CDMS by 43%.
Teriflunomide is an immunomodulator with anti-inflammatory properties. Although the drug’s exact mechanism of action is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system.
In the U.S., Aubagio (teriflunomide) is indicated for the treatment of adult patients with relapsing forms of MS. The recommended dosage is 7 mg or 14 mg once daily.
Source: Genzyme; October 3, 2013.