A study in The Lancet found that higher, bodyweight-adjusted doses of ocrelizumab did not improve disability outcomes for Multiple Sclerosis (MS) patients compared to the standard 600 mg dose.
Background
The study investigated whether bodyweight-adjusted high doses of ocrelizumab could better control disability progression in multiple sclerosis (MS) compared to the standard 600 mg dose. It used data from two phase 3b trials, MUSETTE and GAVOTTE, including patients with relapsing MS or primary progressive MS.
Key Findings
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Higher doses (1200–1800 mg) led to greater depletion of CD20-expressing B cells in blood but did not translate into improved clinical outcomes.
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In the MUSETTE trial (relapsing MS), 34% of high-dose patients experienced 12-week composite confirmed disability progression (CCDP) vs. 37% in the standard group (HR 0.93; p=0.53).
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In the GAVOTTE trial (primary progressive MS), 47% of high-dose patients progressed vs. 49% in the standard arm (HR 0.95; p=0.64).
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At week 120, the proportion of patients with B-cell counts below 0.441 cells/µL was higher in the high-dose arms, but this did not correlate with better disability outcomes.
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Both groups showed similar reductions in neurofilament light chain (NfL) levels (37% decrease at week 48).
Conclusion
The researchers concluded that increasing ocrelizumab dose beyond 600 mg does not provide additional benefit in delaying disability progression. The standard 600 mg dose remains the recommended regimen. Safety profiles were similar across groups.