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Two Phase III trials found that remibrutinib, taken twice daily, reduced annualized relapse rates compared with teriflunomide in people with relapsing multiple sclerosis. The studies also reported fewer new MRI lesions, but 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 results presented at the MSToronto2026 meeting and published simultaneously in The Lancet. The findings support further evaluation of the twice-daily oral drug, although its effect on confirmed disability progression was not consistent across the reported measures.
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 to 0.927; P=0.018). In REMODEL-2, rates were 0.080 and 0.116, respectively, with a rate ratio of 0.688 (95% CI 0.487 to 0.972; P=0.034). Both comparisons favored remibrutinib.
The trials also reported fewer new or enlarging T2 lesions with remibrutinib: reductions of 65% in REMODEL-1 and 70% in REMODEL-2 versus teriflunomide, according to investigator Heinz Wiendl. Gadolinium-enhancing lesions were reduced by 66% in each study. At month 12, serum neurofilament light chain, a marker associated with nerve-cell injury, was also lower in the remibrutinib groups.
In pooled data, three-month confirmed disability progression occurred in 11.7% of remibrutinib recipients and 14.1% of teriflunomide recipients; the difference was not statistically significant (hazard ratio 0.80, P=0.090). Six-month confirmed progression occurred in 7.7% and 10.5%, respectively, a statistically significant difference (HR 0.70, 95% CI 0.51 to 0.98; P=0.038). These results describe different assessment periods and should not be treated as interchangeable.
Relapse Results and Disability Measures
Relapses and MRI activity are central measures of inflammatory disease activity in relapsing MS. The lower relapse rates and lesion counts reported in both trials suggest remibrutinib may offer an oral treatment option that reduces those measures compared with teriflunomide, an established MS therapy. The fact that both studies reported results favoring remibrutinib adds weight to the relapse finding, though it does not settle how the drug compares with the wider range of MS treatments.
The disability findings are more qualified. The pooled three-month measure did not reach statistical significance, while the six-month measure did. The results therefore do not establish a uniform effect across disability endpoints, and the reported data do not show whether lower relapse activity will translate into sustained functional benefit over longer periods. Treatment choices also depend on individual circumstances and a medicine’s full benefit-risk profile, not relapse rates alone.
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How the REMODEL Trials Were Run
REMODEL-1 enrolled 1,000 participants and REMODEL-2 enrolled 1,007. Both studies included adults aged 18 to 55 with relapsing MS and evidence of recent disease activity. Participants were randomly assigned to remibrutinib 100 mg twice daily or teriflunomide 14 mg once daily. The average baseline Expanded Disability Status Scale score was about 2.5; the scale runs from 0 to 10, with higher scores indicating greater disability.
The safety findings include a point of attention alongside the efficacy results. Newly occurring liver enzyme elevations were described as infrequent, transient and reversible, and investigators reported no cases meeting Hy’s Law criteria, which are used to identify a concerning pattern of potential drug-induced liver injury. Bleeding events were more frequent with remibrutinib than teriflunomide, at 12.7% versus 6.7%. The most common reported adverse events included upper respiratory infections, nasopharyngitis, diarrhea and alopecia.
Remibrutinib is a BTK inhibitor. A 25-mg formulation is approved for chronic spontaneous urticaria and symptomatic dermographism; the MS trials tested a different dose, 100 mg twice daily. Results from this MS program remain distinct from the drug’s use in those other conditions.
“In REMODEL-1 and REMODEL-2, there is a highly significant reduction, 65% and 70%.”
— Heinz Wiendl, University of Freiburg, presenting the REMODEL results
Long-Term Benefits and Safety
The reported results do not establish whether remibrutinib slows disability accumulation over the long term. The three-month progression comparison was not statistically significant, and the six-month finding needs to be interpreted alongside the full trial data and follow-up. The supplied report does not give the duration of follow-up or a full account of all subgroup results.
Further questions include how remibrutinib will compare with other available MS therapies, how its safety profile will look with broader use, and whether bleeding or liver-related risks differ in particular patient groups. The reports describe no Hy’s Law cases and no clear liver signal in these trials, but that is not a guarantee of zero risk. The two deaths reported among remibrutinib recipients—one from carbon monoxide poisoning and one suicide—were considered unrelated to treatment by the investigators; the available account does not provide further detail on causality assessment.
Regulatory Review and Trial Follow-Up
Novartis said it plans to seek regulatory approval globally for remibrutinib in relapsing MS. The source report did not specify when applications would be filed or which regulators would receive them first. Any approval decision will depend on regulatory review of the trial data, including efficacy and safety.
For now, the key next steps are the publication and review of the complete study evidence and any regulatory submissions or decisions. Longer follow-up and additional safety information will help clarify whether the relapse and MRI results are accompanied by durable effects on disability and how the treatment’s risks compare with alternatives.
Key Questions
What did the Phase III trials find?
Both trials found lower annualized relapse rates with remibrutinib 100 mg twice daily than with teriflunomide 14 mg once daily in adults with relapsing MS and recent disease activity.
Did remibrutinib reduce disability progression?
The pooled three-month confirmed disability progression result was not statistically significant. The six-month measure favored remibrutinib and was statistically significant. These findings do not by themselves establish a long-term effect on disability.
What safety findings were reported?
Investigators reported no cases meeting Hy’s Law criteria, and described new liver enzyme elevations as infrequent, transient and reversible. Bleeding events were reported in 12.7% with remibrutinib versus 6.7% with teriflunomide; the full benefit-risk profile requires regulatory and clinical review.
Is remibrutinib approved for multiple sclerosis?
The supplied report says Novartis plans to seek global regulatory approval for remibrutinib in relapsing MS. It does not report an approval for this use. A 25-mg formulation is approved for certain skin conditions, but the MS trials tested 100 mg twice daily.
When could the drug become available for MS?
No filing or decision dates were provided. Availability for MS would depend on regulatory submissions and decisions in individual regions.
Source: rss
