Genzyme-Sanofi announce positive results from the TOPIC trial for teriflunomide. The trial waCalendars designed to assess whether early initiation of teriflunomide in CISers can prevent or delay conversion to clinically definite multiple sclerosis (CDMS).
The average duration of teriflunomide exposure in TOPIC was approximately 16 months. Adverse events observed in the trial were consistent with previous clinical trials with teriflunomide in MS. The most common types of adverse events reported more frequently in the teriflunomide arms were ALT (Alanine transaminase) elevations, nasopharyngitis, headache, hair thinning, diarrhea and paresthesia. There were no deaths reported in either teriflunomide group over the course of the study. There was one death due to suicide in the placebo arm. The rate of treatment discontinuation due to adverse events was similar across treatment arms (9.1 per cent in placebo arm, compared to 12.1 per cent in 7 mg teriflunomide arm and 8.3 per cent in 14 mg teriflunomide arm).
“These results are consistent with the phase 3 trials in RRMS and are not unexpected. They will make a difference if teriflunomide gets a license for CIS; a tablet will be more desirable than the injectable treatments.”