Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension.
Adult
Antibodies, Monoclonal, Humanized
/ adverse effects
Brain
/ pathology
Female
Follow-Up Studies
Humans
Immunologic Factors
/ adverse effects
Magnetic Resonance Imaging
Male
Multiple Sclerosis, Relapsing-Remitting
/ drug therapy
Neuroimaging
Randomized Controlled Trials as Topic
/ statistics & numerical data
Recurrence
Time Factors
Treatment Outcome
Journal
Neurology
ISSN: 1526-632X
Titre abrégé: Neurology
Pays: United States
ID NLM: 0401060
Informations de publication
Date de publication:
29 09 2020
29 09 2020
Historique:
received:
10
07
2019
accepted:
10
04
2020
pubmed:
22
7
2020
medline:
15
12
2020
entrez:
22
7
2020
Statut:
ppublish
Résumé
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: I/II studies in relapsing multiple sclerosis. 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 (CDP)/improvement (CDP), brain MRI activity (gadolinium-enhanced and new/enlarging T2 lesions), and percentage brain volume change were analyzed. 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; 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. This study provides Class III evidence that earlier and continuous treatment with OCR provided sustained benefit on clinical and MRI outcomes of disease activity and progression compared with patients switching from IFN-β-1a. The study is rated Class III because of the initial treatment randomization disclosure that occurred after inclusion in OLE. NCT01247324/NCT01412333.
Identifiants
pubmed: 32690791
pii: WNL.0000000000010376
doi: 10.1212/WNL.0000000000010376
pmc: PMC7682822
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Immunologic Factors
0
ocrelizumab
A10SJL62JY
Banques de données
ClinicalTrials.gov
['NCT01412333', 'NCT01247324']
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e1854-e1867Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR003167
Pays : United States
Informations de copyright
Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
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