Key clinical point: Earlier and continuous ocrelizumab treatment provided sustained benefits on measures of disease progression in patients with primary progressive multiple sclerosis (PPMS).
Major finding: Over a period of 6.5 study years, the proportion of patients with progression on disability measures at 24 weeks was lower in those who started ocrelizumab early vs. those who started with placebo: Expanded Disability Status Scale Score (51.7% vs. 64.8%; P = .0018), 9-Hole Peg Test (30.6% vs. 43.1%; P = .0035), Timed 25-Foot Walk (63.2% vs. 70.7%; P = .058), and composite progression (73.2% vs. 83.3%; P = .0023). No new safety signals emerged compared with the double-blind phase of ORATORIO.
Study details: The findings are based on a long-term follow-up from the phase 3 ORATORIO extension study. 732 patients with PPMS were randomly assigned (2:1) to receive ocrelizumab or placebo every 24 weeks for at least 120 weeks. Overall, 544 participants completed the double-blind period and 527 people entered the open-label extension phase, during which they continued ocrelizumab or switched from placebo to ocrelizumab.
Disclosures: The study was funded by F Hoffmann-La Roche. The presenting author received personal fees for consulting, serving on a scientific advisory board, speaking, or other activities with AbbVie, Actelion, Alkermes, Brainstorm Cell Therapeutics, Celgene, EMD Serono, GeNeuro, GW Pharma, MedDay Pharmaceuticals, NervGen Pharma, Novartis, Otsuka, PTC Therapeutics, Roche/Genentech, and Sanofi Genzyme; and royalties for out licensed monoclonal antibodies through UTHealth from Millipore Corporation.
Source: Wolinsky JS et al. Lancet Neurol. 2020 Oct 29. doi: 10.1016/S1474-4422(20)30342-2 .