Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension.

Neurology
Stephen L HauserXavier Montalban

Abstract

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; 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 ...Continue Reading

Associated Datasets

References

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Dec 22, 2016·The New England Journal of Medicine·Stephen L HauserUNKNOWN OPERA I and OPERA II Clinical Investigators
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Citations

Jan 23, 2021·Multiple Sclerosis and Related Disorders·Richard HughesHarold Koendgen
Jan 27, 2021·Journal of the Neurological Sciences·Gauruv Bose, Mark S Freedman
Mar 17, 2021·Neurology. Neuroimmunology and Neuroinflammation·Alexandre AvouacBertrand Audoin
Jan 8, 2021·Neurology. Neuroimmunology and Neuroinflammation·Jonas GrafHans-Peter Hartung
Apr 22, 2021·Neurotherapeutics : the Journal of the American Society for Experimental NeuroTherapeutics·Esther S FrischMartin S Weber
Mar 31, 2021·Current Opinion in Neurology·Finn Sellebjerg, Martin S Weber
Mar 17, 2021·European Journal of Neurology : the Official Journal of the European Federation of Neurological Societies·Gavin GiovannoniJerry S Wolinsky
Jun 3, 2021·Multiple Sclerosis and Related Disorders·Hamza CobanJaime Imitola
Jul 24, 2021·Der Nervenarzt·Heinz WiendlUNKNOWN die Multiple Sklerose Therapie Konsensus Gruppe (MSTKG)
Aug 7, 2021·Therapeutics and Clinical Risk Management·Chiara Rosa MancinelliRuggero Capra
Aug 8, 2021·Neurological Research and Practice·Ludwig Kappos
Aug 13, 2021·Journal of Neurology·Monica MargoniMaria A Rocca
Aug 24, 2021·Therapeutic Advances in Neurological Disorders·Heinz WiendlUNKNOWN ‘Multiple Sclerosis Therapy Consensus Group’ (MSTCG)
Aug 28, 2021·ImmunoTargets and Therapy·Michael Levy, Maureen A Mealy
Sep 24, 2021·Neurotherapeutics : the Journal of the American Society for Experimental NeuroTherapeutics·Maria CellerinoMatilde Inglese
Sep 24, 2021·Current Pharmaceutical Design·Marcel GebhardtUwe K Zettl

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Clinical Trials Mentioned

NCT01247324
NCT01412333

Software Mentioned

OPERA
SIENA

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