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Ocrelizumab in early relapsing-remitting multiple sclerosis: first interim analysis of the MUSPO Italian prospective
Massimo Filippi1,2,3,4,5, Emanuele D'Amico6, Vincenzo Brescia Morra7,8
1Neurology Unit, IRCCS San Raffaele Scientific Institute, Via Olgettina, 60 - 20132, Milan, Italy. filippi.massimo@hsr.it.
Background:
Real-world evidence on ocrelizumab in early, minimally pretreated relapsing multiple sclerosis (MS) patients remains limited.
Objective:
To describe baseline demographic, clinical, radiological, and treatment characteristics of the MUSPO cohort.
Methods:
MUSPO 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.
Results:
Of 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.
Conclusions:
The 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.
Insights
This study describes the baseline characteristics of early multiple sclerosis patients treated with ocrelizumab in Italy. The MUSPO cohort is young, mildly disabled, and provides a foundation for evaluating treatment effectiveness.
Area of Science:
- Neurology
- Immunology
- Clinical Research
Background:
- Limited real-world data exists for ocrelizumab in early, minimally pretreated relapsing multiple sclerosis (MS).
- Understanding patient characteristics is crucial for evaluating treatment outcomes.
Purpose of the Study:
- To characterize the demographic, clinical, radiological, and treatment profiles of the MUSPO cohort.
- To establish a baseline for longitudinal assessment of ocrelizumab effectiveness in Italian MS patients.
Main Methods:
- Prospective, multicenter, observational study (MUSPO) enrolling adults with relapsing-remitting MS (RRMS) and rapidly evolving severe RRMS (RES).
- Enrollment occurred ~6 months after ocrelizumab initiation, with MRI and cognitive assessments.
- NEDA-plus (No Evidence of Disease Activity-plus) will be assessed longitudinally.
Main Results:
- 199 patients (59 RRMS, 140 RES) were analyzed from 31 Italian sites.
- Median Expanded Disability Status Scale (EDSS) was 2.0, indicating mild disability.
- 29.6% had prior disease-modifying therapy (DMT) exposure; median time to ocrelizumab was 1.4 months.
Conclusions:
- The MUSPO cohort represents a young, mildly disabled, early-treated population.
- Comprehensive baseline MRI and limited prior DMT use support robust evaluation of NEDA-plus and effectiveness.
- This study provides a strong foundation for real-world ocrelizumab effectiveness research in Italy.
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