Novartis: Remibrutinib Cuts Relapses vs Teriflunomide in Relapsing MS

Remibrutinib (Novartis), an oral Bruton’s tyrosine kinase (BTK) inhibitor, reduced annualized relapse rates compared with teriflunomide in adults with relapsing multiple sclerosis (RMS) in 2 phase 3 trials, Novartis announced. The REMODEL-1 and REMODEL-2 results were presented at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting, and published simultaneously in The Lancet.

According to Novartis, remibrutinib is a selective, covalent BTK inhibitor that reduces activation of B cells and innate immune cells and is designed to modulate BTK signaling without chronic B-cell depletion.

The identical multicenter, randomized, double-blind trials (REMODEL-1 and REMODEL-2) enrolled approximately 2,000 adults with RMS who had evidence of recent disease activity and an Expanded Disability Status Scale score of 0.0 to 5.5. Patients were randomly assigned 1:1 to remibrutinib 100mg or teriflunomide for a double-blind period of up to 30 months. The annualized relapse rate, the primary endpoint, was 0.073 with remibrutinib vs 0.112 with teriflunomide in REMODEL-1 and 0.080 vs 0.116 in REMODEL-2, relative reductions of 35.2% and 31.2% that Novartis reported as statistically significant.

Remibrutinib also reduced annualized T2 lesion activity and Gd+ T1 lesions per scan in both trials. In a prespecified pooled analysis of both trials, the risk of 6-month confirmed disability progression was 29.2% lower with remibrutinib, a result Novartis described as nominally significant. The risk of 3-month confirmed disability progression was 20.5% lower, but the difference was not statistically significant (hazard ratio, 0.80; 95% CI, 0.61–1.04; P = 0.09). The company described this latter finding as a positive trend. Novartis reported no liver safety signal, including no Hy’s Law cases. Alanine aminotransferase elevations above 3 times the upper limit of normal occurred in 2.0% of remibrutinib-treated patients and 7.4% of teriflunomide-treated patients. Serious adverse events occurred in 6.0% and 7.0%, respectively. Two deaths occurred in the remibrutinib group, from accidental carbon monoxide poisoning and suicide; investigators assessed both as unrelated to treatment.

Novartis said it plans to seek regulatory approval for remibrutinib in RMS globally. Remibrutinib 25mg is FDA approved as Rhapsido for adults with chronic spontaneous urticaria and symptomatic dermographism; the REMODEL trials evaluated a 100mg dose.

Source: Novartis. Novartis remibrutinib delivered comprehensive disease control in phase III RMS trials, with proven, robust safety profile. Press release. Novartis; October 23, 2026. Accessed October 25, 2026.