New data suggests that Aubagio (teriflunomide; Sanofi Genzyme) may delay conversion to clinically definite multiple sclerosis (CDMS) by slowing the loss of cortical gray matter. The data comes from a post hoc analysis of the Phase 3 TOPIC study which includes results from the 2-year core study and the 4-year extension study.
The overall two-year data showed that compared to placebo, Aubagio significantly reduced cortical gray matter volume (CGMV) loss (Aubagio 7mg, P=0.0089; Aubagio 14mg, P=0.0052) and the risk of CDMD conversion.
To evaluate the association of CGMV loss and CDMS conversion, patients continuing in the extension study were categorized into three groups. Group 1 (n=140) experienced the least CGMV loss, Group 2 (n=251) experienced intermediate levels of CGMV loss and Group 3 (n=94) experienced the most CGMV loss.
Results from the 4-year data showed that patients in Group 1 had a 45.1% lower risk of conversion to CDMS than those in Group 3 (P=0.0104), and patients in Group 2 had a 34.5% lower risk than those in Group 3 (P=0.0361).
“The effects of Aubagio on reducing CGMV loss and the relationship between CGMV loss and conversion to CDMS provide insight into how Aubagio may impact the early inflammatory and neurodegenerative components of MS,” said Robert Zivadinov, MD, PhD, professor of neurology at the University of Buffalo, NY.
The full findings from the extension trial will be presented at the European and Americas Committees for Research and Treatment in Multiple Sclerosis today, being held in Paris.
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