Remibrutinib Cuts MS Relapse Rates by About a Third Compared With Teriflunomide
Two phase 3 trials found fewer MS relapses with remibrutinib than teriflunomide, but long-term disability benefits remain unclear.
Summary
An oral drug called remibrutinib reduced relapses more than teriflunomide in two large trials involving 2,007 adults with relapsing multiple sclerosis. Participants received one of the treatments at random, and neither they nor investigators knew which treatment they received. Over up to 30 months, remibrutinib lowered relapse rates by about 35% in one trial and 31% in the other. Because relapse rates were low in both groups, the absolute difference was roughly four fewer relapses per 100 patient-years. Fewer participants stopped remibrutinib because of side effects, and researchers reported no liver safety concerns. These results suggest another potential oral treatment option, but they do not establish better protection against lasting disability. This summary relies on the abstract only; the manufacturer funded the trials, and longer follow-up is needed.
Detailed Summary
Multiple sclerosis can disrupt movement, vision, and daily independence through repeated attacks on the nervous system. An oral treatment that reduces relapses could help control disease activity. Two large trials now suggest remibrutinib reduces relapses more effectively than teriflunomide, an established oral treatment, although the abstract does not establish better protection against lasting disability.
Researchers enrolled 2,007 adults aged 18 to 55 with active relapsing multiple sclerosis across 407 centers in 46 countries. Participants were randomly assigned to remibrutinib twice daily or teriflunomide once daily. Neither participants nor investigators knew the treatment assignments. The two trials measured confirmed relapses per patient per year over up to 30 months.
In REMODEL-1, annual relapse rates were 0.073 with remibrutinib and 0.112 with teriflunomide, a relative reduction of about 35%. In REMODEL-2, rates were 0.080 versus 0.116, about a 31% reduction. Both differences were statistically significant. Absolute differences were modest, equivalent to roughly four fewer relapses per 100 patient-years in each trial.
Common side effects included respiratory infections, diarrhea, and hair loss. Treatment discontinuation because of adverse events occurred in 3.1% receiving remibrutinib versus 5.8% receiving teriflunomide. Hair loss was also less common with remibrutinib. Researchers reported no liver safety concerns, but this does not rule out rare or delayed harms. These results support remibrutinib as a potential additional oral option for relapsing disease.
This summary is based on the abstract only. The trials were funded by Novartis, and several authors were company employees. Participants older than 55 and those with more advanced disability were not represented. The abstract does not report detailed disability outcomes, brain imaging results, or comparisons with other highly effective treatments. Patients should discuss these findings with their neurologist rather than change therapy independently. Reduced relapses are encouraging, but longer follow-up is needed to clarify durable benefits and safety.
Key Findings
- Remibrutinib reduced annual relapse rates by approximately 35% in REMODEL-1 and 31% in REMODEL-2 compared with teriflunomide.
- Absolute reductions amounted to roughly four fewer relapses per 100 patient-years in each trial.
- Adverse events led to treatment discontinuation in 3.1% taking remibrutinib versus 5.8% taking teriflunomide.
- Hair loss occurred in 5.8% with remibrutinib versus 13.5% with teriflunomide; researchers reported no liver safety concerns.
- The abstract does not establish improved long-term disability outcomes; discuss treatment implications with a neurologist.
Methodology
REMODEL-1 and REMODEL-2 were identical randomized, double-blind, double-dummy, active-comparator phase 3 trials involving 2,007 adults at 407 centers in 46 countries. Participants received remibrutinib 100 mg twice daily or teriflunomide 14 mg daily; the primary endpoint was annualized relapse rate, assessed in all randomized participants over up to 30 months.
Study Limitations
This summary is based on the abstract only, which does not provide detailed disability, imaging, or rare adverse-event results. Participants were aged 18–55 with disability scores of 0–5.5, limiting generalizability to older adults and those with more advanced disability. Novartis funded the trials, several authors were company employees, and longer follow-up is needed to assess durable benefits and safety.
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