Observational studyJournal of neurology2026
Ocrelizumab in early relapsing-remitting multiple sclerosis: first interim analysis of the MUSPO Italian prospective cohort.
Observational study in Journal of neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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16 authors.
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Abstract
backgroundReal-world evidence on ocrelizumab in early, minimally pretreated relapsing multiple sclerosis (MS) patients remains limited.
objectiveTo describe baseline demographic, clinical, radiological, and treatment characteristics of the MUSPO cohort.
methodsMUSPO is a prospective, multicenter, observational study. Enrollment occurred from September 2023 to May 2025. Adults with relapsing-remitting MS (RRMS), including a rapidly evolving severe RRMS (RES) group, were enrolled ~ 6 months after starting ocrelizumab. MRI was acquired according to clinical practice with centralized reading. NEDA-plus (absence of relapses, disability worsening, MRI activity, brain atrophy, and cognitive worsening) will be assessed at years 1-4. Baseline descriptive statistics were used.
resultsOf 208 patients enrolled across 31 Italian sites, 199 were eligible (RRMS N = 59; RES N = 140) for the interim analysis. Median Expanded Disability Status Scale was 2.0 (IQR 1.0-3.0), indicating mild disability. Prior disease-modifying therapy (DMT) exposure occurred in 59/199 patients (29.6%); time from last DMT to ocrelizumab was a median 1.4 months (IQR 0.7-2.0). MRI at diagnosis was available for 188/199 patients (94.5%), gadolinium used in 157/188 scans (83.5%). Baseline MRI was available for all patients with gadolinium administered in 166/199 cases (83.4%). Cognitive assessment using the Symbol Digit Modalities Test was completed by 150/199 (75.4%) of patients.
conclusionsThe MUSPO study captures a predominantly young, mildly disabled, early-treated cohort, some of whom have prior DMT exposure. Together with comprehensive baseline MRI and limited prior DMT use, these features provide a robust foundation to evaluate NEDA-plus and other longitudinal effectiveness endpoints in Italian practice.
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