BASEL — Novartis presented results from the Phase III REMODEL-1 and REMODEL-2 trials for remibrutinib in relapsing multiple sclerosis at the MSToronto2026 meeting on October 23, 2026. The results were published in The Lancet on the same date. Primary source: doi.org

In the REMODEL-1 trial, the annualized relapse rate was 0.073 for patients treated with remibrutinib compared to 0.112 for those treated with teriflunomide, a 35.2% relative reduction. The REMODEL-2 trial showed an annualized relapse rate of 0.080 for remibrutinib versus 0.116 for teriflunomide, a 31.2% relative reduction.

Remibrutinib reduced the risk of 6-month confirmed disability progression by 29.2% with nominal significance compared to teriflunomide. More than 92% of patients receiving remibrutinib remained free from disease progression over 24 months as assessed by 6-month confirmed disability progression, and the drug showed a 20.5% reduction in 3-month confirmed disability progression.

In pooled analysis, 55.0% of patients receiving remibrutinib achieved no evidence of disease activity (NEDA-3) compared to 32.1% of patients receiving teriflunomide. Patients receiving remibrutinib had approximately three times higher odds of achieving overall disease control compared to patients receiving teriflunomide in pooled analysis.

In the REMODEL-1 trial, the annualized T2 lesion activity rate was 0.94 for remibrutinib compared to 2.71 for teriflunomide, while the REMODEL-2 trial recorded rates of 0.82 and 2.77 respectively. The rate of Gd+ T1 lesions per scan was 0.08 for remibrutinib versus 0.24 for teriflunomide in REMODEL-1, and 0.07 versus 0.21 in REMODEL-2. Serum neurofilament light chain levels improved by 9.0% in the REMODEL-1 trial and 7.0% in the REMODEL-2 trial for remibrutinib compared to teriflunomide.

No Hy’s Law cases of liver injury were observed in the remibrutinib trials. ALT elevations greater than three times the upper limit of normal occurred in 2.0% of patients treated with remibrutinib compared to 7.4% of patients treated with teriflunomide. Treatment discontinuations due to adverse events were 3.1% for remibrutinib compared to 5.8% for teriflunomide.

Serious adverse events were reported in 6.0% of patients receiving remibrutinib compared to 7.0% of patients receiving teriflunomide. Two deaths occurred in the remibrutinib group, one due to accidental carbon monoxide poisoning and one due to suicide, both assessed as unrelated to study treatment. Approximately 2,000 patients globally were randomized 1:1 to receive remibrutinib 100 mg or teriflunomide in the REMODEL-1 and REMODEL-2 trials.

"The REMODEL trial results showed that oral remibrutinib delivered a significant reduction in relapse activity while also showing a clinically meaningful effect on confirmed disability progression in people living with relapsing MS," Heinz Wiendl, Professor of Neurology at the University of Freiburg, said. "As treatment goals in MS continue to evolve beyond relapse control alone, these efficacy findings, together with the favorable safety profile, suggest remibrutinib has the potential to deliver a meaningful, differentiated treatment option for people living with RMS."

"The Phase III REMODEL results reinforce our confidence in remibrutinib and its potential to expand treatment choice for people living with RMS," Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis, said. Novartis plans to seek regulatory approval for remibrutinib in relapsing multiple sclerosis globally.

Remibrutinib 25 mg was approved by the FDA for chronic spontaneous urticaria in September 2025. Remibrutinib was approved by the European Medicines Agency for chronic spontaneous urticaria in April 2026. Remibrutinib received FDA approval for symptomatic dermographism in October 2026.