Persistent Identifier
|
doi:10.5683/SP2/5LTCGL |
Publication Date
|
2021-05-20 |
Title
| Five-years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension |
Other Identifier
| Dryad: doi:10.5061/dryad.stqjq2bzw |
Author
| Hauser, Stephen L (University of California, Berkeley)
Kappos, Ludwig (University Hospital of Basel)
Arnold, Douglas L (McGill University)
Bar-Or, Amit (University of Pennsylvania)
Brochet, Bruno (Centre Hospitalier Universitaire de Bordeaux)
Naismith, Robert T (Washington University in St. Louis School of Medicine)
Traboulsee, Anthony (University of British Columbia) - ORCID: 0000-0002-0351-9639
Wolinsky, Jerry S (The University of Texas Health Science Center at Houston) - ORCID: 0000-0002-8197-2762
Belachew, Shibeshih (Roche (Switzerland))
Koendgen, Harold (Roche (Switzerland))
Levesque, Victoria (Genetec (United States))
Manfrini, Marianna (Roche (Switzerland))
Model, Fabian (Roche (Switzerland))
Hubeaux, Stanislas (Roche (Switzerland))
Mehta, Lahar (Genetec (United States))
Montalban, Xavier (University of Toronto) |
Point of Contact
|
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Hauser, Stephen L (University of California, Berkeley)
Kappos, Ludwig (University Hospital of Basel)
Arnold, Douglas L (McGill University)
Bar-Or, Amit (University of Pennsylvania)
Brochet, Bruno (Centre Hospitalier Universitaire de Bordeaux)
Naismith, Robert T (Washington University in St. Louis School of Medicine)
Traboulsee, Anthony (University of British Columbia)
Wolinsky, Jerry S (The University of Texas Health Science Center at Houston)
Belachew, Shibeshih (Roche (Switzerland))
Koendgen, Harold (Roche (Switzerland))
Levesque, Victoria (Genetec (United States))
Manfrini, Marianna (Roche (Switzerland))
Model, Fabian (Roche (Switzerland))
Hubeaux, Stanislas (Roche (Switzerland))
Mehta, Lahar (Genetec (United States))
Montalban, Xavier (University of Toronto)
UBC Library Research Data Team |
Description
| Abstract
Objective
To assess over 3 years of follow-up, the effects of maintaining or switching to ocrelizumab (OCR) therapy on clinical and MRI outcomes and safety measures in the open-label extension (OLE) phase of the pooled OPERA studies in relapsing multiple sclerosis.
Methods
After 2 years of double-blind, controlled treatment, patients continued OCR (600 mg infusions every 24 weeks) or switched from interferon (IFN) β-1a (44 μg 3 times weekly) to OCR when entering the OLE phase (3 years). Adjusted annualized relapse rate, time to onset of 24-week confirmed disability progression/improvement (CDP/CDI), brain MRI activity (gadolinium-enhanced and new/enlarging T2 lesions), and percentage brain volume change were analyzed.
Results
Of patients entering the OLE phase, 88.6% completed Year 5. The cumulative proportion with 24-week CDP was lower in patients who initiated OCR earlier, vs patients initially receiving IFN β-1a (16.1% vs 21.3% at Year 5; p=0.014). Patients continuing OCR maintained, and those switching from IFN β-1a to OCR attained near complete and sustained suppression of new brain MRI lesion activity from Year 3 to 5. Over the OLE phase, patients continuing OCR exhibited less whole brain volume loss from double-blind study baseline vs those switching from IFN β-1a (–1.87% vs –2.15% at Year 5; p<0.01). Adverse events were consistent with past reports and no new safety signals emerged with prolonged treatment.
Conclusion
Compared with patients switching from IFN β-1a, earlier and continuous OCR treatment up to 5 years provided sustained benefit on clinical and MRI measures of disease progression. (2020-08-13) |
Subject
| Other |
Keyword
| All Clinical Neurology (Dryad)
All Clinical trials (Dryad)
Multiple Sclerosis (Dryad) |
Related Publication
| Article doi: https://doi.org/10.1056/NEJMoa1601277
Article doi: https://doi.org/10.1212/WNL.0000000000010376 |
Notes
| Dryad version number: 4
Version status: submitted
Dryad curation status: Published
Sharing link: https://datadryad.org/stash/share/G8Ajycvu9FYBISwShOf5PihKvvY6pcXgk5eS-QJdXAU
Storage size: 1036426
Visibility: public |
Funding Information
| F. Hoffmann-La Roche |
Distribution Date
| 2020-08-10 |
Deposit Date
| 2020-08-13 |