Top-line results from the TOWER trial that assessed the efficacy and safety of once-daily, oral teriflunomide in MSers with relapsing forms of MS have just been released.
MSers receiving teriflunomide 14 mg had a statistically significant reduction in annualised relapse rate and risk of sustained accumulation of disability. This double-blind, multi-center trial enrolled 1,169 MSers and compared once-daily treatment with either 7 mg or 14 mg oral teriflunomide against placebo. Results from the primary and secondary endpoints for the proposed 14 mg commercial dose include the following:
- A 36.3% reduction in annualised relapse rate, the primary endpoint of the trial, was observed in MSers who received teriflunomide compared to placebo .
- A 31.5% reduction in the risk of 12-week sustained accumulation of disability, the main secondary endpoint, as measured by the EDSS was observed with teriflunomide compared to placebo.
- A 22.3% reduction in annualised relapse rate was observed in MSers treated with teriflunomide 7 mg compared to placebo (p=0.02); there was no statistically significant difference observed between teriflunomide 7 mg and placebo for the risk of 12-week sustained accumulation of disability.
- There was one death from a respiratory infection in the placebo arm and three deaths in the teriflunomide arms from a motor vehicle accident, suicide and sepsis.
- MSers who completed the trial were followed for a period between 48 and 173 weeks. The average duration of teriflunomide exposure in TOWER was 18 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 headache, ALT elevations, hair thinning, diarrhea, nausea and neutropenia (low white blood cell counts).
Marketing applications for teriflunomide for the treatment of relapsing forms of MS are under review by the FDA and EMA.
“It looks as if the 7mg dose is dead and buried. Let’s hope the EMA give Teriflunomide a first-line license for RRMS and that NICE a greenlight on cost-effectiveness. The latter will depend on its price.”
“Teriflunomide will be a good first-line option instead of an injectable.”