TOPIC Extension Study: Teriflunomide a "Well Tolerated" Oral Agent for Long-Term Multiple Sclerosis

At AAN 2017, Aaron Miller, MD, Mount Sinai discussed results of the TOPIC trial that investigated the administration of (7 and 17mg) teriflunomide vs. placebo in multiple sclerosis patients with clinically isolated syndromes with a primary endpoint of the conversion to clinically definite multiple sclerosis, meaning a new relapse.

According to Miller, the pivotal portion of the double blind randomized trial demonstrated a 43% reduction in the conversion to clinically definite MS for the 14mg dose of teriflunomide. The TOPIC Extension trial then took patients who had been in the original, randomized trial and re-randomized the patients who completed that trial. The patients who were originally assigned to either 7 or 14mg of teriflunomide were continued on those doses and patients who had been originally assigned to placebo were re-randomized to either 7 or 14mg of teriflunomide.

The results of the nearly 7-year extension trial presented a 47% reduction overall in conversion to clinically definite MS with those patients who had been on 14mg of teriflunomide from the beginning. However, when looking at all the patients in the trial, approximately 2/3 of patients that were followed up to 7 years did not convert to clinically definite multiple sclerosis.