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Sunday, September 14, 2014

Teriflunomide (AUBAGIO) Is Now the First Oral Regimen Proven to Delay Onset of Clinically Definite Multiple Sclerosis

Author: Michael R. Page, PharmD, RPh

In a recent phase III trial published on September 2, 2014, in the journal Lancet Neurology, Miller et al clarify the role of oral teriflunomide (Aubagio) in the treatment of early episodes of demyelinating symptoms suggestive of multiple sclerosis.1

This randomized, double-blind, placebo-controlled study, known as the TOPIC study, evaluated the safety and efficacy of teriflunomide for patients between the ages of 18 and 55 years who had experienced their first instance of a clinically isolated syndrome in the 90 days prior to randomization in the trial. Importantly, each patient involved in the study was required to have at least 2 MRI-determined lesions (measured using T2-weighted MRI) at least 3 mm in diameter.1

In the 618-patient, 112-center study spanning 20 countries, patients were randomized in a 1:1:1 ratio to receive teriflunomide 14 mg daily (n = 216), teriflunomide 7 mg daily (n = 205), or placebo (n = 197) for up to 108 weeks.1

Investigators assessed the amount of time between the initial neurological event and any new neurological event—an event that would mark the transition from a clinically isolated syndrome to clinically definite multiple sclerosis (CDMS). Secondarily, investigators assessed MRI outcomes, including occurrence of new gadolinium-enhancing or T2 lesions.1

The study used an intent-to-treat design, but excluded 2 patients from the study who were randomized to receive teriflunomide but never received a dose of study medication.1

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