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Five-years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension Hauser, Stephen L; Kappos, Ludwig; Arnold, Douglas L; Bar-Or, Amit; Brochet, Bruno; Naismith, Robert T; Traboulsee, Anthony; Wolinsky, Jerry S; Belachew, Shibeshih; Koendgen, Harold; Levesque, Victoria; Manfrini, Marianna; Model, Fabian; Hubeaux, Stanislas; Mehta, Lahar; Montalban, Xavier

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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.

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Title	Five-years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension
Creator	Hauser, Stephen L; Kappos, Ludwig; Arnold, Douglas L; Bar-Or, Amit; Brochet, Bruno; Naismith, Robert T; Traboulsee, Anthony; Wolinsky, Jerry S; Belachew, Shibeshih; Koendgen, Harold; Levesque, Victoria; Manfrini, Marianna; Model, Fabian; Hubeaux, Stanislas; Mehta, Lahar; Montalban, Xavier
Date Issued	2021-05-20
Description	<b>Abstract</b><br/><p style="margin-bottom:4px;"><b>Objective</b></p> <p style="margin-bottom:4px;">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.</p> <p style="margin-bottom:4px;"><b>Methods</b></p> <p style="margin-bottom:4px;">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.</p> <p style="margin-bottom:4px;"><b>Results</b></p> <p style="margin-bottom:4px;">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; <i>p</i>=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; <i>p</i><0.01). Adverse events were consistent with past reports and no new safety signals emerged with prolonged treatment.</p> <p style="margin-bottom:4px;"><b>Conclusion</b></p> <p style="margin-bottom:4px;">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.</p>
Subject	Other; All Clinical Neurology; All Clinical trials; Multiple Sclerosis
Type	Dataset
Notes	Dryad version number: 4</p> Version status: submitted</p> Dryad curation status: Published</p> Sharing link: https://datadryad.org/stash/share/G8Ajycvu9FYBISwShOf5PihKvvY6pcXgk5eS-QJdXAU</p> Storage size: 1036426</p> Visibility: public</p>
Date Available	2020-08-13
Provider	University of British Columbia Library
License	CC0 1.0
DOI	10.14288/1.0397557
URI	https://doi.org/10.5683/SP2/5LTCGL
Publisher DOI	https://doi.org/10.5683/SP2/5LTCGL; https://doi.org/10.5061/dryad.stqjq2bzw
Rights URI	http://creativecommons.org/publicdomain/zero/1.0
Aggregated Source Repository	Dataverse

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