Teriflunomide for Pediatric Multiple Sclerosis

Teriflunomide has been approved for adults with relapsing forms of multiple sclerosis (MS) since 2012. To test the drug in a pediatric population, investigators recruited 166 patients aged 10 to 17 years with active relapsing MS to this multicenter, placebo-controlled, manufacturer-sponsored study. Randomization was 2:1, with 109 assigned to teriflunomide and 57 to placebo. For safety, placebo-assigned participants would be placed in the open-label extension for a confirmed relapse or highly active brain MRI during the study. Of the 57 assigned placebo, 22 were early completers due to confirmed relapses and 15 due to high MRI activity.

The primary outcome of time to first relapse up to 96 weeks was not significantly better with teriflunomide…