Five years of ocrelizumab in relapsing multiple sclerosis : OPERA studies open-label extension
Hauser, Stephen L. (University of California)
Kappos, Ludwig (University of Basel)
Arnold, Douglas Lorne (McGill University)
Bar-Or, Amit (University of Pennsylvania)
Brochet, Bruno (Department of Neurology. CHU de Bordeaux)
Naismith, Robert (Washington University School of Medicine)
Traboulsee, Anthony (University of British Columbia)
Wolinsky, Jerry (University of Texas Health Science Center at Houston (UTHealth))
Belachew, Shibeshih (F. Hoffmann-La Roche Ltd)
Koendgen, Harold (F. Hoffmann-La Roche Ltd)
Levesque, Victoria (Genentech. Inc.)
Manfrini, Marianna (F. Hoffmann-La Roche Ltd)
Model, Fabian (F. Hoffmann-La Roche Ltd)
Hubeaux, Stanislas (F. Hoffmann-La Roche Ltd)
Mehta, Lahar (Genentech. Inc.)
Montalban, Xavier (Hospital Universitari Vall d'Hebron)
Universitat Autònoma de Barcelona. Departament de Medicina

Fecha:	2020
Resumen:	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: I/II 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 g 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. 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 years 3-5. 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. ConclusionCompared 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. Classification of evidenceThis 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. Clinical trial identifiersNCT01247324/NCT01412333.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Publicado en:	Neurology, Vol. 95 Núm. 13 (september 2020) , p. E1854-E1867, ISSN 1526-632X

DOI: 10.1212/WNL.0000000000010376
PMID: 32690791

15 p, 1.2 MB

El registro aparece en las colecciones:
Artículos > Artículos de investigación
Artículos > Artículos publicados