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Ten Years of Ocrelizumab in Relapsing Multiple Sclerosis: The OPERA I and II Randomized Clinical Trials
In a study of 1656 patients with relapsing MS, continuous treatment with ocrelizumab (OCR) over 10 years reduced the risk of 48-week confirmed disability progression by 24% compared to those who started treatment later with interferon (IFN). Most patients on OCR remained disability-free and experienced lowered relapse rates over time without an increase in serious adverse events.
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This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
These findings suggest that prolonged use of ocrelizumab may lead to better long-term outcomes in managing relapsing MS, highlighting its potential role in treatment strategies.
What this does not prove
The study does not establish the effects of ocrelizumab beyond 10 years or evidence of its efficacy in individuals outside the study population.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 1656 · basis not reported
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Yes
- Relevant MS type
- RRMS
- Publication date
- 2026-10-05
- Evidence reviewed
- Abstract only
- Regulatory approval
- Not reported
- Research areas
- Other
Original sources
- Primary evidenceTen Years of Ocrelizumab in Relapsing Multiple Sclerosis: The OPERA I and II Randomized Clinical Trials. ↗DOI: 10.1001/jamaneurol.2026.3507
Supporting passages (15)
study phaseDESIGN, SETTING, AND PARTICIPANTS: In 2 phase 3 multicenter randomized clinical trials (OPERA I and II), patients were randomized to OCR or interferon beta-1a (IFN) throughout a 2-year double-blind period (DBP) and entered an open-label extension (OLE) to receive OCR for up to an additional 8 years.
study designDESIGN, SETTING, AND PARTICIPANTS: In 2 phase 3 multicenter randomized clinical trials (OPERA I and II), patients were randomized to OCR or interferon beta-1a (IFN) throughout a 2-year double-blind period (DBP) and entered an open-label extension (OLE) to receive OCR for up to an additional 8 years.
sample sizeA total of 1656 patients were randomized, and 1651 patients received either OCR (n = 825) or IFN (n = 826).
randomizedDESIGN, SETTING, AND PARTICIPANTS: In 2 phase 3 multicenter randomized clinical trials (OPERA I and II), patients were randomized to OCR or interferon beta-1a (IFN) throughout a 2-year double-blind period (DBP) and entered an open-label extension (OLE) to receive OCR for up to an additional 8 years.
controlledDESIGN, SETTING, AND PARTICIPANTS: In 2 phase 3 multicenter randomized clinical trials (OPERA I and II), patients were randomized to OCR or interferon beta-1a (IFN) throughout a 2-year double-blind period (DBP) and entered an open-label extension (OLE) to receive OCR for up to an additional 8 years.
primary endpoint metOver 10 years, continuous OCR (OCR-OCR) significantly reduced the hazard of 48-week CDP by 24% compared with delayed initiation (IFN-OCR; hazard ratio, 0.76; 95% CI, 0.61-0.95; P = .02), with 680 patients (82.2%) receiving OCR-OCR remaining free of 48-week CDP and 712 (86.1%) free of PIRA.
research categoriesOBJECTIVE: To assess 10-year safety and efficacy of ocrelizumab (OCR) in patients with relapsing MS (RMS).
relevant ms typesPatients with RMS, aged 18 to 55 years, with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, and at least 1 relapse within the year before screening were eligible for inclusion.
interventionINTERVENTIONS: OCR (600 mg every 24 weeks) or IFN (44 µg 3 times weekly) in the DBP, then OCR during the OLE.
comparatorINTERVENTIONS: OCR (600 mg every 24 weeks) or IFN (44 µg 3 times weekly) in the DBP, then OCR during the OLE.
primary endpointMAIN OUTCOMES AND MEASURES: Outcomes included time to onset of 48-week confirmed disability progression (CDP) or progression independent of relapse activity (PIRA); time to reach EDSS score of 4.0 and 6.0; relapse rates; and incidence of adverse events (AEs) and serious AEs.
follow upDESIGN, SETTING, AND PARTICIPANTS: In 2 phase 3 multicenter randomized clinical trials (OPERA I and II), patients were randomized to OCR or interferon beta-1a (IFN) throughout a 2-year double-blind period (DBP) and entered an open-label extension (OLE) to receive OCR for up to an additional 8 years.
findingsOver 10 years, continuous OCR (OCR-OCR) significantly reduced the hazard of 48-week CDP by 24% compared with delayed initiation (IFN-OCR; hazard ratio, 0.76; 95% CI, 0.61-0.95; P = .02), with 680 patients (82.2%) receiving OCR-OCR remaining free of 48-week CDP and 712 (86.1%) free of PIRA.
publication datePublication date: 2026-10-05
limitationsTitle: Ten Years of Ocrelizumab in Relapsing Multiple Sclerosis: The OPERA I and II Randomized Clinical Trials.
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