Study Finds Aubagio Well-tolerated and Efficient in Long-term MS Treatment

Researchers at the University of Texas Health Science Center at Houston, in collaboration with various institutions from north America and Europe, found that teriflunomide (Aubagio) is well-tolerated and efficient for long-term treatment of multiple sclerosis (MS).

The findings, entitled “Long-term safety and efficacy of teriflunomide,” were published in Neurology, the official journal of the American Academy of Neurology.

From the therapeutic standpoint, no cure has yet to be developed for MS, but many medications are currently available to relieve the symptoms and slow down disease progression. Among them, teriflunomide, also known by its brand name Aubagio (Genzyme) is approved for relapsing-remitting multiple sclerosis (RRMS) with 2-year positive results.

“Three randomized placebo-controlled trials in relapsing MS supported the registration and approval of teriflunomide for RRMS treatment. Collectively, these studies demonstrated the efficacy of teriflunomide on disability, annualized relapse rate (ARR), and MRI [magnetic resonance imaging] markers of disease. The trials demonstrated a consistent safety and tolerability profile for teriflunomide used for 2 years,” the authors wrote in their article.

In the extension study (NCT00803049) of the phase 3 Teriflunomide Multiple Sclerosis Oral (TEMSO) trial (NCT00134563), the researchers investigated the long-term (9-year) safety and efficacy of teriflunomide treatment.

A total of 742 MS patients were included in the extension study, in which patients treated with teriflunomide continued on the basis of the original dosage, and those receiving placebo prior to the extension were randomized 1:1 to teriflunomide 14 mg or 7 mg.

The results showed that teriflunomide is well-tolerated for long-term exposure exceeding 190 weeks per patient, and among 468 patients (63%) remained on treatment. With respect to adverse events (AEs), no significant change was recorded from those obtained at the core study, based mainly on increased transient liver enzymes or reversible hair thinning attributable to the switch from placebo to teriflunomide. Around 11% of patients discontinued the treatment due to AEs, and 20% experienced serious AEs.

Relapse rates and gadolinium-enhancing T1 lesion counts reduced in patients when the extension study began due to the switch from placebo to teriflunomide, and was maintained low afterward. Also, disability was maintained stable in all treated groups.

“Overall, the results of this study provide further evidence that the effects of teriflunomide are maintained with longer term treatment and also support previous observations that teriflunomide has a well-characterized and manageable long-term safety profile,” concluded the researchers.

MS is the most common autoimmune disorder of the brain, resulting in its damage through inflammation and tissue loss. The disease is considered the major cause of disability in young adults, causing difficulties in various functionalities, including movement/coordination, speech/swallowing, and vision, among others.