Journal
MULTIPLE SCLEROSIS JOURNAL
Volume 28, Issue 12, Pages 1927-1936Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/13524585221097561
Keywords
Ocrelizumab; multiple sclerosis; thalamus; atrophy; treatment outcome
Categories
Funding
- F. Hoffmann-La Roche Ltd, Basel, Switzerland
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Ocrelizumab significantly reduces thalamic volume loss in patients with multiple sclerosis, and the protective effect on thalamic tissue preservation persists over time.
Background: In multiple sclerosis (MS), thalamic integrity is affected directly by demyelination and neuronal loss, and indirectly by gray/white matter lesions outside the thalamus, altering thalamic neuronal projections. Objective: To assess the efficacy of ocrelizumab compared with interferon beta-1a (IFN beta 1a)/placebo on thalamic volume loss and the effect of switching to ocrelizumab on volume change in the Phase III trials in relapsing MS (RMS, OPERA I/II; NCT01247324/NCT01412333) and in primary progressive MS (PPMS, ORATORIO; NCT01194570). Methods: Thalamic volume change was computed using paired Jacobian integration and analyzed using an adjusted mixed-effects repeated measurement model. Results: Over the double-blind period, ocrelizumab treatment significantly reduced thalamic volume loss with the largest effect size (Cohen's d: RMS: 0.561 at week 96; PPMS: 0.427 at week 120) compared with whole brain, cortical gray matter, and white matter volume loss. At the end of up to 7 years of follow-up, patients initially randomized to ocrelizumab still showed less thalamic volume loss than those switching from IFN beta 1a (p < 0.001) or placebo (p < 0.001). Conclusion: Ocrelizumab effectively reduced thalamic volume loss compared with IFN beta 1a/placebo. Early treatment effects on thalamic tissue preservation persisted over time. Thalamic volume loss could be a potential sensitive marker of persisting tissue damage.
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