For patients with radiologically isolated syndrome (RIS), the earliest detectable preclinical phase of multiple sclerosis (MS), treatment with Aubagio (teriflunomide; Sanofi, Bridgewater, NJ) resulted in a 72% adjusted risk reduction in preventing a first clinical demyelinating event according to new research. Aubagio is a pyrimidine synthesis inhibitor approved in adults to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. These findings, published in JAMA Neurology, suggest that early treatment with Aubagio may delay MS progression.

The 96-week, multicenter, double-blind, phase 3, randomized clinical trial included 89 enrolled adult participants who met the 2009 RIS diagnostic criteria. Participants were randomly assigned (1:1) to receive either a daily 14mg dose of oral Aubagio or placebo. After the 96-week study period, participants had the option to continue treatment until week 144.

  • Participants treated with Aubagio experienced a significant extension in time to the first clinical event compared to those receiving the placebo in both the unadjusted (hazard ratio [HR], 0.37; 95% CI, 0.16-0.84; P = .02) and adjusted (HR, 0.28; 95% CI, 0.11-0.71; P = .007) analyses.
  • The comparison of the cumulative number of new, newly enlarging, or newly enhancing lesions and the proportion of participants with new lesions was not found to be significant.

Source: Lebrun-Frénay C, Siva A, Sormani MP, et al. Teriflunomide and time to clinical multiple sclerosis in patients with radiologically isolated syndrome: the TERIS randomized clinical trial. JAMA Neurol. 2023;80(10):1080–1088. doi:10.1001/jamaneurol.2023.2815