Teriflunomide delays onset of disease in those with early signs of MS

Dr Miller

There is value in treating multiple sclerosis (MS) early, according to results from a study presented during the 66th American Academy of Neurology (AAN) Annual Meeting in Philadelphia.

The randomized, double-blind, placebo-controlled phase III TOPIC trial (Teriflunomide vs. Placebo in Patients with First Clinical Symptom of MS) was designed to assess whether early initiation of oral teriflunomide (Aubagio) in patients who experienced their first neurological symptoms consistent with clinically isolated syndrome (CIS) can prevent or delay a second clinical attack, ie, conversion to clinically definite multiple sclerosis (CDMS). The 2-year study compared 14 mg and 7 mg of once-daily teriflunomide versus placebo in 618 patients who experienced their first clinical episode suggestive of MS and had MRI scans showing two or more T2 legions.

The primary end point was the time to conversion to CDMS, defined by a second clinical attack. Secondary end points included time to new clinical relapse or MRI lesion and other MRI measures. Safety and tolerability were also assessed and the adverse events (AEs) observed in TOPIC were consistent with those seen in previous trials of teriflunomide in MS. Teriflunomide is a once-daily oral treatment approved for the treatment of patients with relapsing forms of MS.

“For formulary managers, [teriflunomide] is the only oral MS treatment at this time to report efficacy results in patients with clinically isolated syndrome,” said Aaron Miller, MD, medical director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at the Icahn School of Medicine at Mount Sinai, New York, NY.

In this trial, patients receiving teriflunomide 14 mg and 7 mg were significantly less likely to develop a second clinical attack compared to patients on placebo, according to the study results. Teriflunomide 14 mg reduced the risk of conversion to CDMS by 43% (P=.0087).

“How patients tolerate a drug is also important and in this study, patients tolerated teriflunomide quite well,” said Dr Miller. 

Teriflunomide is an oral immunomodulator with anti-inflammatory properties. Although the exact mechanism of action in not fully understood, the research suggests that teriflunomide works differently than other MS therapies by blocking the reproduction of overactive immune cells (including T- and B-cells) that attack and damage nerves in the central nervous system that may cause MS inflammation.

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