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Background <p>Real-world evidence on ocrelizumab in early, minimally pretreated relapsing multiple sclerosis (MS) patients remains limited.</p> Objective <p>To describe baseline demographic, clinical, radiological, and treatment characteristics of the MUSPO cohort.</p> Methods <p>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&#xa0;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.</p> Results <p>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&#xa0;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.</p> Conclusions <p>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.</p>

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Ocrelizumab in early relapsing–remitting multiple sclerosis: first interim analysis of the MUSPO Italian prospective cohort

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月4日

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  • Massimo Filippi,
  • Emanuele D’Amico,
  • Vincenzo Brescia Morra,
  • Chiara Zanetta,
  • Aurora Zanghì,
  • Paola Sofia Di Filippo,
  • Elena Longobardi,
  • Elena Colombo,
  • Massimiliano Mirabella,
  • Antonella Conte,
  • Valentina Tomassini,
  • Cinzia Masini,
  • Valeria Perosino,
  • Paola Tortorella,
  • Maria Assunta Rocca,
  • Massimilian Calabrese,
  • Alessia Di Sapio,
  • Diana Ferraro,
  • Elisabetta Signoriello,
  • Giuseppe Salemi,
  • Salvatore Cottone,
  • Mattea Modesto,
  • Francesco Patti,
  • Girolama Marfia,
  • Giorgia Teresa Maniscalco,
  • Maria Matilde Inglese,
  • Antonio Gallo,
  • Pietro Annovazzi,
  • Paola Perini,
  • Stefano De Biase,
  • Diego Centonze,
  • Alessandra Protti,
  • Simone Lorenzut,
  • Sara Montepietra,
  • Maria Grazia Piscaglia,
  • Marco Rovaris,
  • Maria Pia Amato

摘要

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.