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Two Phase III studies found that remibrutinib, taken twice daily, reduced annualized relapse rates versus teriflunomide in people with relapsing multiple sclerosis. The results also showed fewer new MRI lesions, while the pooled result for three-month confirmed disability progression was not statistically significant. Novartis said it plans to seek global regulatory approval for remibrutinib in relapsing MS.
Remibrutinib reduced annualized relapse rates compared with teriflunomide in two Phase III trials involving people with relapsing multiple sclerosis, according to findings reported October 25 at MSToronto2026 and published in The Lancet. The results support the drugmaker Novartis’ plan to seek regulatory approval for remibrutinib in relapsing MS, but they do not establish that it slows disability progression across all measures.
In REMODEL-1, the annualized relapse rate was 0.073 among patients taking remibrutinib and 0.112 among those taking teriflunomide. The rate ratio was 0.648 (95% confidence interval 0.453 to 0.927; P=0.018). In REMODEL-2, the corresponding rates were 0.080 and 0.116, with a rate ratio of 0.688 (95% CI 0.487 to 0.972; P=0.034). Both trials tested remibrutinib 100 mg twice daily against teriflunomide 14 mg once daily.
The studies also found fewer new or enlarging T2 MRI lesions with remibrutinib: reductions of 65% in REMODEL-1 and 70% in REMODEL-2 compared with teriflunomide, as reported by investigator Heinz Wiendl. Gadolinium-enhancing lesions were reduced by 66% in each trial. At month 12, serum neurofilament light chain, a marker of nerve-cell injury, was also lower in the remibrutinib groups.
In pooled trial data, three-month confirmed disability progression occurred in 11.7% of remibrutinib recipients and 14.1% of teriflunomide recipients. That difference did not reach statistical significance (hazard ratio 0.80; P=0.090). Six-month confirmed progression occurred in 7.7% and 10.5%, respectively, a statistically significant difference (hazard ratio 0.70; 95% CI 0.51 to 0.98; P=0.038). These are distinct measures and should not be read as proof of a broad or definitive disability benefit.
Relapse Results and Disability Measures
Relapses and MRI lesions are measures of inflammatory disease activity in relapsing MS. The consistent relapse-rate results in two large trials, each enrolling about 1,000 participants, make remibrutinib a potential additional treatment option if regulators approve it for this use. The comparison was against an established oral therapy, teriflunomide, rather than against every available MS treatment.
The disability findings call for a measured reading of the results. The three-month progression outcome was not statistically significant, while the six-month measure favored remibrutinib. Trial results can inform treatment decisions, but they do not show how an individual patient will respond or establish comparative benefits against therapies not studied in these trials. Regulatory review and further evidence will shape how the findings affect care.
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Who Took Part in REMODEL
REMODEL-1 enrolled 1,000 participants and REMODEL-2 enrolled 1,007. Participants were 18 to 55 years old, had evidence of recent relapsing disease activity, and had Expanded Disability Status Scale scores from 0 to 5.5 at entry. The average baseline score was about 2.5; the scale runs from 0 to 10, with higher scores indicating greater disability.
Participants had an average age of 38 to 39, and 67% were women. On average, they had experienced MS symptoms for more than six years and had been diagnosed for more than four years. The results therefore apply most directly to a population with relapsing MS and recent disease activity within the trials’ age and disability criteria.
Remibrutinib is a Bruton’s tyrosine kinase inhibitor. A 25 mg formulation is approved for chronic spontaneous urticaria and symptomatic dermographism, but those approvals do not establish approval for MS. Other BTK inhibitor trials in MS have raised liver-safety concerns, making the liver findings in REMODEL relevant to ongoing evaluation of the drug class.
“In REMODEL-1 and REMODEL-2, there is a highly significant reduction, 65% and 70%.”
— Heinz Wiendl, MD, University of Freiburg, presenting the results at MSToronto2026
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Safety and Longer-Term Effects
The available report does not establish how remibrutinib performs over longer periods or how its benefits and risks compare with other MS therapies. The trials enrolled people with recent disease activity and specified age and disability ranges, so the findings may not apply equally to all people with MS. The non-significant three-month disability result also leaves uncertainty about the drug’s effect on progression.
New liver enzyme elevations were described as infrequent, transient and reversible, and no cases met Hy’s Law criteria, which are used to identify potential severe drug-induced liver injury. These trial observations do not rule out rare risks that may become apparent with broader or longer use. Bleeding events occurred in 12.7% of remibrutinib recipients versus 6.7% with teriflunomide; the report described these as generally mild, but the difference remains relevant to safety assessment. Two deaths occurred in the remibrutinib group and were considered unrelated to the drug by investigators, according to the report.
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Regulatory Review and Further Evidence
Novartis plans to seek regulatory approval for remibrutinib in relapsing MS globally. The company and regulators will need to address the full trial data, including relapse and MRI outcomes, disability measures and safety findings. The source report did not specify when applications will be filed or when decisions might be expected.
Until a decision is made, remibrutinib’s existing approvals for other conditions do not make it an approved MS treatment. Further follow-up and post-approval safety monitoring, if the drug is authorized for MS, will help clarify the duration of benefit and the frequency of uncommon adverse effects.
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Key Questions
What did the Phase III trials find?
Both REMODEL trials found lower annualized relapse rates with remibrutinib than with teriflunomide in people with relapsing MS. The trials also reported fewer new or enlarging MRI lesions with remibrutinib.
Did remibrutinib prevent disability progression?
The pooled three-month confirmed progression result favored remibrutinib but was not statistically significant. The six-month measure favored remibrutinib and was statistically significant; the findings do not establish a benefit across every disability measure.
What safety findings were reported?
The report said new liver enzyme elevations were infrequent, transient and reversible, with no cases meeting Hy’s Law criteria. Bleeding events were more frequent with remibrutinib than teriflunomide (12.7% versus 6.7%); longer-term and rare risks remain to be assessed.
Is remibrutinib approved to treat MS?
The source report says Novartis plans to seek global regulatory approval for remibrutinib in relapsing MS. Its existing approvals for other conditions do not mean it is approved for MS.
Source: rss
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