Treatment with remibrutinib (Novartis, East Hanover, NJ), an oral Bruton tyrosine kinase (BTK) inhibitor, was associated with lower relapse activity than Aubagio (teriflunomide; Sanofi, Cambridge, MA) in adults with relapsing multiple sclerosis (RMS) across the phase 3 REMODEL-1 (NCT05147220) and REMODEL-2 (NCT05156281) trials.

The findings, presented at MSToronto2026 and published in The Lancet, also showed lower MRI lesion activity with remibrutinib treatment and a nominally significant reduction in 6-month confirmed disability progression in pooled analyses.

The randomized, double-blind trials enrolled 2007 participants across 46 countries. Participants received remibrutinib or Aubagio, with the annualized relapse rate (ARR) as the primary endpoint.

Key results include the following:

  • In REMODEL-1, the ARR was 0.073 with remibrutinib vs 0.112 with Aubagio, corresponding to a 35.2% relative reduction.
  • In REMODEL-2, the ARR was 0.080 with remibrutinib vs 0.116 with Aubagio, a 31.2% relative reduction.
  • Annualized T2 lesion activity was 0.94 with remibrutinib vs 2.71 with Aubagio in REMODEL-1 and 0.82 vs 2.77, in REMODEL-2.
  • In pooled analyses, remibrutinib was associated with a 29.2% lower risk of 6-month confirmed disability progression, with nominal statistical significance.
  • Alanine aminotransferase elevations greater than 3 times the upper limit of normal occurred in 2.0% of participants receiving remibrutinib and 7.4% receiving Aubagio.
  • No liver safety signal or Hy’s Law cases were reported.

Source: Wiendl H, Bermel RA, Airas L, et al. Efficacy and safety of remibrutinib vs teriflunomide in relapsing multiple sclerosis: results of the phase 3 REMODEL-1/-2 trials. Paper presented at: MS Toronto 2026; October 20-23, 2026; Toronto, ON, Canada.

Wiendl H, Bermel R, Airas L, et al. Remibrutinib versus teriflunomide in relapsing multiple sclerosis (REMODEL-1 and REMODEL-2): two randomised, phase 3 trials. Lancet. Published online October 23, 2026. doi:10.1016/S0140-6736(26)02058-1