New Findings from the REMODEL Studies of Remibrutinib Reported at MSToronto2026
KEY TAKEAWAYS
- Remibrutinib treatment was shown to significantly reduce annualized relapse rates vs teriflunomide in both phase 3 REMODEL trials.
- Treatment was also associated with lower T2 and gadolinium-enhancing T1 lesion activity and a nominally significant reduction in 6-month confirmed disability progression in pooled analyses.
- No liver safety signal or Hy’s Law cases were reported.
Treatment with remibrutinib (Novartis, East Hanover, NJ), an oral Bruton tyrosine kinase (BTK) inhibitor, was associated with significantly reduced relapse activity compared with Aubagio (teriflunomide; Sanofi, Cambridge, MA) in adults with relapsing multiple sclerosis (RMS). The findings from the phase 3 REMODEL-1 (NCT05147220) and REMODEL-2 (NCT05156281) clinical trials were presented at MSToronto2026 and are now published in The Lancet.
The randomized, double-blind REMODEL trials included 2007 participants at 407 centers across 46 countries. Participants received treatment with remibrutinib 100 mg twice daily or Aubagio 14 mg once daily, with annualized relapse rate (ARR) as the primary end point.
Efficacy of Remibrutinib Treatment in Relapsing MS
- 0.073 with remibrutinib vs 0.112 with Aubagio in REMODEL-1, a 35.2% relative reduction.
- In REMODEL-2, ARR was 0.080 with remibrutinib vs 0.116 with Aubagio, showing a 31.2% relative reduction.
- Annualized T2 lesion activity was lower in participants treated with remibrutinib in both trials, with rates of 0.94 vs 2.71 with Aubagio in REMODEL-1 and 0.82 vs 2.77 with Aubagio in REMODEL-2.
- In pooled analyses, remibrutinib was associated with a 29.2% lower risk of 6-month confirmed disability progression, with nominal significance.
- Alanine aminotransferase elevations > 3 times the upper limit of normal occurred in 2.0% of participants receiving remibrutinib and 7.4% receiving Aubagio.
Practical Implications in the Clinic
The REMODEL findings provide phase 3 evidence that remibrutinib may affect relapse activity, MRI disease activity, and confirmed disability progression in people with RMS, with no liver safety signal identified.
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