Oral Medication Aubagio® Approved for Multiple Sclerosis

San Diego—In the past, patients with multiple sclerosis were required to administer medications intravenously or via injections, a painful process for some, but they had no other choices. Now, though, treatment options have expanded into oral drugs, including Aubagio^® (teriflunomide).

David Brandes, MD, neurologist at the Hope Neurology Center in Knoxville, Tennessee,  discussed teriflunomide during a Product Theater at the AMCP meeting. Genzyme Corporation, a Sanofi company and the product’s manufacturer, sponsored the session.

The FDA approved teriflunomide in September 2012 to treat patients with relapsing forms of multiple sclerosis. It was the second FDA-approved oral medication for multiple sclerosis, following the 2010 approval of Gilenya^™ (fingolimod) from Novartis AG. In March 2013, the FDA approved Tecfidera^™ (dimethyl fumarate) from Biogen Idec, the third oral drug for multiple sclerosis.

Dr. Brandes cited data as of February 14, 2013, that found the wholesale acquisition cost of teriflunomide was $45,000 per patient per year compared with $60,423 per patient per year for fingolimod. At the time, dimethyl fumarate had not been FDA approved, but Biogen Idec has since said the drug would cost $54,900 per patient per year.

Teriflunomide was less expensive than all of the other FDA-approved therapies as well,  according to data Dr. Brandes presented (cost comparison data did not include comparisons of the safety or efficacy of the products).

Patients take 7 mg or 14 mg of teriflunomide once daily with or without food. Dr. Brandes noted teriflunomide is contraindicated in patients with severe hepatic impairment, patients who are pregnant, women of childbearing potential who are not using reliable contraception, and patients who are receiving leflunomide.

The approval of teriflunomide was based on results of the TEMSO [Teriflunomide Multiple Sclerosis Oral] trial, a phase 3, randomized, double-blind, placebo-controlled, parallel-group study. Patients were between 18 and 55 years of age, had a score of 0 to 5.5 on the Expanded Disability Status Scale, and had at least 1 relapse in the previous year or at least 2 relapses in the previous 2 years, with none of the relapses occurring in the 60 days before randomization.

The authors randomized patients in a 1:1:1 ratio to receive placebo, 7 mg of teriflunomide, or 14 mg of teriflunomide once daily for 108 weeks. The groups were well balanced. The mean age was approximately 38 years, approximately 70% of patients were female, and approximately 97% were white.

Compared with the placebo group, the groups of patients taking 14 mg of teriflunomide or 7 mg of teriflunomide each had a 31% reduction in the rate of relapse (P<.001). In addition, after 108 weeks of treatment, 57% more patients in the 14-mg teriflunomide group remained free from relapse compared with the placebo group (P=.003), while 54% more patients in the 7-mg teriflunomide group remained free from relapse compared with the placebo group (P=.01).

Further, there was a 30% reduction in the risk of sustained disability progression in the 14-mg teriflunomide group compared with the placebo group (P=.03), and there was a 24% risk reduction in the 7-mg teriflunomide group compared with the placebo group (P=.08).

Adverse events were similar in the 3 groups, affecting approximately 90% of patients. In addition, serious adverse events were found in 15.9% of patients taking 14 mg of teriflunomide, 14.1% of patients taking 7 mg of teriflunomide, and 12.8% of patients in the placebo group. None of the adverse events led to death.

Common adverse events included diarrhea, nausea, alopecia, influenza, parasthesia, and an increase in alanine aminotransferase. The discontinuation rates due to adverse events were 10.9% for patients taking 14 mg of teriflunomide, 9.8% for patients taking 7 mg of teriflunomide, and 8.1% for patients in the placebo group.