Related Experiment Video
Updated: Jun 12, 2025
10:46
A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
Published on: December 9, 2015
10.7K
Safety and efficacy of evobrutinib in relapsing multiple sclerosis (evolutionRMS1 and evolutionRMS2): two
Xavier Montalban1, Patrick Vermersch2, Douglas L Arnold3
1Department of Neurology, Centre d'Esclerosi Múltiple de Catalunya, Hospital Universitario Vall d'Hebron, Barcelona, Spain.
The Lancet. Neurology
|September 22, 2024
Summary
Evobrutinib did not show superior efficacy compared to teriflunomide for relapsing multiple sclerosis. Safety concerns, particularly liver enzyme elevations, suggest evobrutinib is not recommended for this condition.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Evobrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, previously demonstrated preliminary efficacy in relapsing multiple sclerosis (RMS).
- This study aimed to compare the safety and efficacy of evobrutinib against teriflunomide in RMS patients.
Purpose of the Study:
- To compare the efficacy of evobrutinib versus teriflunomide in patients with relapsing multiple sclerosis.
- To assess and compare the safety profiles of evobrutinib and teriflunomide in this patient population.
Main Methods:
- Two multicenter, randomized, double-blind, active-controlled Phase 3 trials (evolutionRMS1 and evolutionRMS2) enrolled adults with RMS.
- Participants received either evobrutinib (45 mg twice daily) or teriflunomide (14 mg once daily) for 156 weeks.
- The primary endpoint was the annualized relapse rate, assessed using a negative binomial model.
Main Results:
- Evobrutinib showed non-inferior efficacy to teriflunomide, with similar annualized relapse rates in both trials (RR 1.02 and 1.00).
- Treatment-emergent adverse events were comparable, but serious adverse events were higher with evobrutinib.
- Liver enzyme elevations (≥5x ULN) were more frequent with evobrutinib, particularly within the first 12 weeks.
Conclusions:
- Evobrutinib's efficacy was not superior to teriflunomide in patients with relapsing multiple sclerosis.
- Increased liver enzyme elevations and a higher rate of serious adverse events with evobrutinib do not support its use.
- The findings suggest that evobrutinib is not a recommended treatment option for relapsing multiple sclerosis.
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