To evaluate the efficacy of fenebrutinib, an oral BTK inhibitor, compared to OCREVUS in reducing disability progression in patients with primary progressive multiple sclerosis (PPMS).
Key Findings:
Fenebrutinib was non-inferior to OCREVUS in reducing disability progression.
A numerical 12% reduction in the risk of disability progression was observed with fenebrutinib compared to OCREVUS.
The strongest treatment effect was noted in upper limb function, with a 26% reduction in risk of worsening on the nine-hole peg test.
Post-hoc analysis indicated a 22% reduction in risk of progression on a composite endpoint including EDSS and upper limb function.
Interpretation:
Fenebrutinib demonstrated consistent clinical benefits, particularly in upper limb function, which is crucial for maintaining independence in patients with PPMS.
Limitations:
Safety findings showed more frequent transient liver enzyme elevations with fenebrutinib, though no severe liver injuries were reported.
Common adverse events included infections, nausea, and hemorrhage, with similar rates of serious adverse events between groups.
Conclusion:
If approved, fenebrutinib could be the first oral therapy to demonstrate a reduction in disability progression in PPMS, offering a new treatment option for patients.
