Background The efficacy and safety of ocrelizumab in relapsing multiple sclerosis were demonstrated in the double-blind control period of the Phase III OPERA I/II trials (NCT01247324/NCT01412333). Here we assessed the efficacy of switching to or maintaining ocrelizumab therapy after 3 years’ follow-up in the open-label extensions (OLEs) of these studies.
Methods At OLE commencement, patients continued ocrelizumab (OCR-OCR) or switched from interferon-β-1a (IFN) to ocrelizumab (IFN-OCR). Adjusted annualised relapse rate (ARR) and time-to-onset of 24-week confirmed disability progression (CDP24) were analysed.
Results Among IFN-OCR patients, ARR decreased from 0.20 in the year pre-switch to 0.10, 0.08 and 0.07 at Years 1, 2 and 3 post-switch. OCR-OCR continuers maintained low ARRs through the year pre-OLE and the 3 years of OLE (0.13, 0.11, 0.08, 0.07). CDP24 was less frequent in OCR-OCR continuers versus IFN-OCR switchers in the year pre-switch and Years 1, 2 and 3 of OLE (7.7%/12.0%, 10.1%/15.6%, 13.9%/18.1% and 16.1%/21.3%; p<0.05, all comparisons).
Conclusions Switching from IFN to ocrelizumab at the start of the OLE provided rapid reductions in ARR, maintained throughout the 3-year follow-up. After 5 years’ follow-up, patients who initiated ocrelizumab 2 years earlier accrued significant, sustained reductions in disability progression compared with patients switching from IFN.
Disclosures Sponsored by F. Hoffmann-La Roche Ltd; writing and editorial assistance was provided by Articulate Science, UK, and funded by F. Hoffmann-La Roche Ltd.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.