Annualized relapse rates (ARR) were significantly lowered for patients treated with 14 mg teriflunomide (Aubagio; Sanofi, Bridgewater, NJ) compared with those treated with placebo. The adjusted ARR was .38 for those treated with teriflunomide vs .59 for those given placebo; ARR reduction was similar for men and women.
Over a cumulative treatment exposure of 1,648 patient years, people treated with teriflunomide were 35% less likely to have a relapse each year (ARR risk reduction [RR] .35; P < .0001). The intention-to-treat group was comprised of 1,708 people, 812 of whom were treated with teriflunomide and 896 who were treated with placebo. Serious adverse events (AEs) occurred in 11.8% of patients given teriflunomide and 12.5% of those who took placebo.
These data represent pooled analysis from phase 2 and phase 3 clinical trials (NCT01487096, NCT00134563, NCT00803049, NCT00751881, NCT00622700, and NCT00883337) and were presented at the American Conference on Treatment and Research in MMS (ACTRIMS) conference in Dallas, TX February 28-March 1.