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Updated: May 30, 2025
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A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
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Long-Term Treatment With Ocrelizumab in Patients With Early-Stage Relapsing MS: Nine-Year Data From the OPERA Studies
João J Cerqueira1, Achim Berthele2, Bruce A C Cree3
1Life and Health Sciences Research Institute, School of Medicine, University of Minho, Braga, Portugal.
Neurology
|January 30, 2025
Summary
Ocrelizumab (OCR) as a first-line therapy for relapsing multiple sclerosis (RMS) demonstrated sustained no evidence of disease activity (NEDA) and reduced disability progression over 9 years compared to interferon. Early treatment with OCR is supported.
Area of Science:
- Neuroimmunology
- Clinical Neurology
- Pharmacology
Background:
- Early initiation of high-efficacy disease-modifying therapies (DMTs) may improve disease control in multiple sclerosis (MS).
- Ocrelizumab (OCR) is a high-efficacy DMT targeting B cells.
- Long-term data on OCR as a first-line treatment for early relapsing MS (RMS) are needed.
Purpose of the Study:
- To assess the long-term efficacy and safety of ocrelizumab (OCR) as a first-line therapy in treatment-naive patients with early-stage relapsing multiple sclerosis (RMS).
- To evaluate sustained no evidence of disease activity (NEDA-3), disability progression, and MRI activity over a 9-year period.
Main Methods:
- Post hoc exploratory analysis of a subgroup of treatment-naive RMS patients from the OPERA I/II studies.
- Patients received either OCR or interferon β-1a for 96 weeks, followed by an open-label extension (OLE) with OCR.
- Efficacy endpoints included NEDA-3, 24-week confirmed disability progression (CDP), MRI lesion activity, and whole-brain volume change over 9 years.
Main Results:
- A significantly higher proportion of OCR-treated patients achieved NEDA-3 compared to interferon-treated patients during the double-blind period (72.5% vs 43.8%), a difference maintained throughout the 7-year OLE (48.2% vs 25.7%).
- No 24-week CDP was observed in 78.7% of OCR-treated patients over 9 years.
- Brain volume loss was numerically higher in patients switching to OCR later; safety profiles were similar between groups, with no new safety signals identified during the OLE.
Conclusions:
- First-line treatment with ocrelizumab (OCR) in early relapsing multiple sclerosis (RMS) leads to sustained no evidence of disease activity (NEDA) and reduced disability progression over 9 years.
- While switching to OCR improved outcomes for interferon-treated patients, disability and brain volume loss accrued during initial interferon treatment were not recovered.
- These findings support the use of OCR as a first-line therapy for patients with early-stage RMS.
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