Remibrutinib Cuts Multiple Sclerosis Relapse Rates in Phase III Trials

Two identical phase III studies, REMODEL-1 and REMODEL-2, demonstrated that the BTK inhibitor remibrutinib cut relapse rates in patients with relapsing multiple sclerosis (MS) compared to teriflunomide (Aubagio). In REMODEL-1, the annualized relapse rate with remibrutinib was 0.073 compared to 0.112 with teriflunomide, while in REMODEL-2, the rates were 0.080 and 0.116 respectively.

This suggests that remibrutinib reduces relapses by approximately one in 13 years. In both studies, remibrutinib also led to significant reductions in new and enlarging T2 lesions and gadolinium-enhancing lesions, as well as lower serum neurofilament light chain levels, a marker of axonal injury. The percentage of patients with 3-month and 6-month confirmed disability progression was also lower with remibrutinib, though not statistically significant.

Adverse events were generally similar between the two treatments, with remibrutinib having a slightly higher incidence of upper respiratory tract infections and alopecia. Bleeding events were more frequent with remibrutinib, but considered usually mild and transient. Remibrutinib is being investigated for other immune-mediated conditions, with Novartis planning to seek regulatory approval for its use in relapsing MS globally.