An analyst explains why the RRMS drug fares well among wider competition.
A new analysis of clinical trial data shows teriflunomide falls somewhere in the middle of the pack as a first-line treatment for relapsing-remitting multiple sclerosis (RRMS). But the author of the paper argues that, given teriflunomide’s safety profile and convenience, the drug ought to remain in wide use despite mounting competition.
The US Food and Drug Administration (FDA) approved teriflunomide as a once-daily oral treatment for RRMS in 2012. The drug is marketed by Sanofi-Genzyme under the name Aubagio.
Since then, a number of “breakthrough” therapies have come into the RRMS market, permanently changing the way many doctors and patients think about the disease. Yet, according to Patrick Vermersch (pictured), PhD, teriflunomide has held up well in that span of time.
New data from two key studies show the drug continues to perform well over time.
Data from the TEMSO study, originally published in 2011, show that no new adverse effects have arisen in patients nine years after the study commenced, and patients who switched to the drug from placebo have seen continually low disease activity.
Similarly, Vermersch notes that follow-up data from the 2014 TOWER study show patients experienced sustained improvement in disability scores over time.
An analysis of the data found that annualized relapse rates dropped by about 30% in both studies for patients who took 7 mg and 14 mg doses, though disability progression only slowed in patients who took the higher dose.
The TEMSO study also found that teriflunomide significantly reduced brain volume, an increasingly important metric in the study of MS.
In a vacuum, all of that data suggests that teriflunomide would have no problem keeping market share. However, the drug is now facing increased competition from a number of high-profile rivals.
“The role of teriflunomide among the growing number of treatment options for MS is unclear,” Vermersch wrote. “In the absence of head-to-head trials, its efficacy relative to other first-line parenteral agents is unknown, but phase III clinical trial data suggest its efficacy is similar to existing injected agents.”
Vermersch said teriflunomide appears to be less effective than fingolimod, the most talked-about member of the new class of disease-modifying MS therapies. But he said other factors, like teriflunomide’s safety profile and ease of use, hold up well against fingolimod.
“The use of an oral drug such as teriflunomide may improve adherence and reduce lifestyle restrictions associated with injected therapies,” he said.
That’s one reason Vermersch said doctors should keep teriflunomide on their list of go-to MS therapies. What he’s less sure of is when in a treatment sequence teriflunomide fits best, and in which patients the drug will work best.
“There is also a need to identify the ideal responder profile to teriflunomide,” he wrote. “Individual genetic or clinical features might predict an optimal response to teriflunomide for a patient at particular stage of the disease.”
Vermersch said the method of action of the drug means it might be most effective in the early and relapsing-remitting stages of multiple sclerosis, because those are the stages where immune response and inflammation must be controlled.
The paper, titled “New and Evolving Treatment Goals in Multiple Sclerosis — the Role of Teriflunomide,” was published in the Summer 2017 issue of the European Neurological Review.