Objective:

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).

Approach:

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.

Source

Based on findings from:

Oral BTK Inhibitor Shows Disability Benefit in Progressive Multiple Sclerosis Trial

The Medicine Maker, 2026.

https://www.themedicinemaker.com/issues/2026/articles/february/oral-btk-inhibitor-shows-disability-benefit-in-progressive-multiple-sclerosis-trial/

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