Four studies of Aubagio show reduced risk of relapse in multiple sclerosis

Patients with relapsing forms of MS who received Aubagio (teriflunomide), from Sanofi, experienced a significantly reduced risk of relapse irrespective of prior treatment status, according to investigational data from four completed clinical studies in multiple sclerosis (MS). The effect of Aubagio 14 mg in subgroups of patients defined by prior treatment was examined in a post-hoc analysis of four clinical studies: the Phase II study, and the Phase III TEMSO, TOWER and TENERE core studies and their extensions.

In the core study period, adjusted annualized relapse rates were significantly lower in patients treated with Aubagio 14 mg (n=955) compared with placebo (n=812) regardless of prior treatment status, with a risk reduction of 35 percent, 45 percent and 34 percent in the treatment naïve, recently treated, and previously treated groups, respectively (p<0.0001; p=0.0029; p=0.0117). In the core and extension period, overall unadjusted annualized relapse rates were low across all prior treatment groups: 0.210, 0.214, 0.281 and 0.335 in the treatment naïve, recently treated with teriflunomide 7 mg, recently treated with another DMT, and previously treated groups, respectively. The probability of disability progression sustained for 12 weeks by year 4 was generally comparable between treatment groups (0.291, 0.250, 0.337, and 0.307) in the treatment naïve, recently treated with teriflunomide 7 mg, recently treated with another DMT, and previously treated groups, respectively. Expanded Disability Status Scale scores remained stable over time across all four groups from baseline to year 8.

The overall occurrence of adverse events, serious adverse events and adverse events leading to treatment discontinuation was comparable between the treatment naïve, recently treated with another DMT, and previously treated groups, and was lower in the recently treated with Aubagio 7 mg. Adverse events observed in more than 10 percent of patients included alanine aminotransferase (ALT/liver enzyme) increase, headache, diarrhea, hair thinning and nausea. There were no new or unexpected safety findings. These results will be presented during the 71st annual meeting of the American Academy of Neurology (AAN) in Philadelphia, PA.