Sanofi Genzyme announced new data for Aubagio (teriflunomide) on cortical gray matter atrophy in patients with a first clinical episode suggestive of multiple sclerosis (MS) at the American Academy of Neurology (AAN) Annual Meeting.
The Phase 3 TOPIC study evaluated whether early initiation of Aubagio in patients with a first clinical episode suggestive of MS could prevent or delay a second attack (ie, conversion to clinically definite MS). Study patients treated with Aubagio 14mg and 7mg had a significantly reduced risk of developing clinically definite MS vs. placebo (P<0.05).
Aubagio demonstrated a consistent and significant effect by decreasing cortical gray matter atrophy across all time points assessed over 2 years. Aubagio 7mg had a relative reduction vs. placebo of 58.2% (P=0.094) at 6 months, 79.8% (P=0.054) at 12 months, 69.5% (P=0.004) at 18 months, and 46.0% (P=0.009) at 24 months. Aubagio 14mg had a relative reduction vs. placebo of 119.2% (P=0.019) at 6 months, 61.4% (P=0.036) at 12 months, 66.8% (P=0.003) at 18 months, and 40.2% (P=0.042) at 24 months.
The rate of serious adverse events was similar between Aubagio vs. placebo groups.
Robert Zivadinov, MD, PhD, from the University of Buffalo, Buffalo, NY, added, “The data being presented at AAN demonstrating that Aubagio slowed the rate of cortical atrophy in patients showing early signs of MS are very promising.”
Aubagio, an immunomodulator, is currently approved to treat relapsing forms of MS. It is available as 7mg or 14mg strength tablets in 5- and 28-count bottles.
For more information call (800) 745-4447 or visit Aubagio.com.