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Two phase III trials found that twice-daily remibrutinib reduced annualized relapse rates compared with teriflunomide in people with relapsing multiple sclerosis. The studies also reported fewer MRI lesions, but the pooled result for three-month confirmed disability progression was not statistically significant. Novartis said it plans to seek regulatory approval for relapsing MS globally.
Remibrutinib lowered annualized relapse rates compared with teriflunomide in two phase III trials involving people with relapsing multiple sclerosis, according to results presented at the MSToronto2026 meeting and published in The Lancet on October 25, 2026. The findings put the oral BTK inhibitor forward as a potential treatment option, although the trials do not establish whether it will slow disability progression across all measures or how regulators will assess its benefits and risks.
In REMODEL-1, the annualized relapse rate was 0.073 with remibrutinib and 0.112 with teriflunomide, a rate ratio of 0.648 (95% confidence interval 0.453-0.927; P=0.018). In REMODEL-2, the corresponding rates were 0.080 and 0.116, with a rate ratio of 0.688 (95% CI 0.487-0.972; P=0.034). Both comparisons favored remibrutinib.
Each trial compared remibrutinib 100 mg twice daily with teriflunomide 14 mg once daily. REMODEL-1 enrolled 1,000 patients and REMODEL-2 enrolled 1,007. Participants were ages 18 to 55, had evidence of recent disease activity and had Expanded Disability Status Scale scores from 0 to 5.5. About two-thirds were women, and the average baseline disability score was approximately 2.5.
The studies also reported fewer new or enlarging T2 lesions with remibrutinib: presenter Heinz Wiendl said the reductions compared with teriflunomide were 65% in REMODEL-1 and 70% in REMODEL-2. Gadolinium-enhancing lesions were reduced by 66% in each trial. At month 12, serum neurofilament light chain, a marker associated with nerve-cell injury, was lower with remibrutinib in both studies. These measures provide evidence of effects on disease activity, but do not by themselves establish a long-term effect on disability.
Relapse Results and Disability Measures
The results matter because relapses and MRI activity are central measures used to evaluate treatments for relapsing MS. The two trials found lower relapse rates against an active comparator, teriflunomide, rather than against a placebo. However, the reported outcomes do not all point to the same level of certainty about disability.
In pooled results, three-month confirmed disability progression occurred in 11.7% of remibrutinib participants and 14.1% of those taking teriflunomide. The estimated risk reduction was not statistically significant (hazard ratio 0.80, 95% CI 0.61-1.04; P=0.090). For six-month confirmed progression, the figures were 7.7% and 10.5%, respectively, with a hazard ratio of 0.70 (95% CI 0.51-0.98; P=0.038). That second result favored remibrutinib, while the first comparison did not meet the conventional threshold for statistical significance.
Safety also matters for this drug class. Wiendl reported no cases meeting Hy’s Law criteria, used to identify a pattern that can signal serious drug-induced liver injury. Bleeding events were more frequent with remibrutinib than teriflunomide, 12.7% versus 6.7%. These findings will be relevant to clinicians and regulators weighing the treatment’s possible benefits against its risks.
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Trial Design and Safety Findings
REMODEL-1 and REMODEL-2 were described as identical phase III studies in adults with relapsing MS and recent disease activity. Participants were randomly assigned to one of the two oral treatments. The results were presented by Wiendl of the University of Freiburg at the joint ECTRIMS and ACTRIMS meeting in Toronto and were published simultaneously in The Lancet, according to the source report.
The most common reported adverse events included upper respiratory tract infections (13.1% with remibrutinib and 13.7% with teriflunomide), nasopharyngitis (9.1% and 12.3%), diarrhea (8.3% and 10.9%), and hair loss (5.8% and 13.5%). Treatment discontinuations due to adverse events were reported in 3.1% with remibrutinib and 5.8% with teriflunomide. Newly occurring liver enzyme elevations were described as infrequent, transient and reversible.
Remibrutinib is a Bruton’s tyrosine kinase inhibitor. A 25-mg formulation is approved for chronic spontaneous urticaria and symptomatic dermographism; that approval is for those conditions, not MS. The report says other BTK inhibitor studies in MS have raised concerns about drug-induced liver injury, making the liver findings in these trials a point of interest rather than proof that liver risks are absent.
“In REMODEL-1 and REMODEL-2, there is a highly significant reduction, 65% and 70%.”
— Heinz Wiendl, University of Freiburg, presenting the trial findings
Open Questions on Benefit and Risk
The reported results do not settle whether remibrutinib will reduce disability progression over the longer term. The pooled three-month progression comparison was not statistically significant, while the six-month result favored remibrutinib; further interpretation depends on the full trial data and any additional follow-up.
The source report does not state how long participants were followed, provide detailed results for every subgroup, or give a regulatory review timeline. While investigators reported no Hy’s Law cases, that finding is not evidence that liver risks are absent. Bleeding events were more frequent in the remibrutinib group, and the report describes them as generally mild and transient based on the presenter’s account. The full safety profile and how it compares with other treatment choices remain matters for review.
The trial report also recorded two deaths among remibrutinib participants: one from carbon monoxide poisoning, for which suicide was ruled out, and one suicide in a person with a prior psychiatric illness. Wiendl said both were considered unrelated to the drug. Those attributions are the investigators’ assessment as reported, not independent proof of causation or lack of causation.
Regulatory Filings and Full Data
Novartis said it plans to seek regulatory approval for relapsing MS globally. The company’s announcement, as reported, did not specify when applications would be filed or which regulatory agencies would receive them first. Regulators will need to assess the trial evidence alongside safety data before deciding whether to authorize the drug for this condition.
Further information to watch for includes the full published trial analyses, longer-term disability and safety follow-up, and any details about planned filings. Until those developments are available, the phase III findings support a reduction in measured relapse rates against teriflunomide, but do not indicate that remibrutinib is approved for MS or establish how it should be used in clinical practice.
Key Questions
What did the REMODEL trials find?
Both phase III trials found lower annualized relapse rates with remibrutinib than with teriflunomide in people with relapsing MS. They also reported fewer MRI lesions with remibrutinib.
Did remibrutinib reduce disability progression?
The pooled result for three-month confirmed progression favored remibrutinib but was not statistically significant. Six-month confirmed progression was lower with remibrutinib, with a statistically significant comparison in the reported analysis.
Was liver injury reported in the trials?
The presenter reported no cases meeting Hy’s Law criteria, and newly occurring liver enzyme elevations were described as infrequent, transient and reversible. This does not mean liver risk has been ruled out.
Is remibrutinib approved for multiple sclerosis?
The report says a 25-mg formulation is approved for chronic spontaneous urticaria and symptomatic dermographism, not MS. Novartis said it plans to seek global approval for relapsing MS; a filing and regulatory decision were not reported.
Source: rss
