Risk of requiring a wheelchair in primary progressive multiple sclerosis: Data from the ORATORIO trial and the MSBase registry
Helmut Butzkueven, Tim Spelman, Dana Horakova, Stella Hughes, Claudio Solaro, Guillermo Izquierdo, Eva Kubala Havrdova, Francois Grand'Maison, Alexandre Prat, Marc Girard, Raymond Hupperts, Marco Onofrj, Alessandra Lugaresi, Bruce Taylor, Gavin Giovannoni, Ludwig Kappos, Stephen L Hauser, Xavier Montalban, Licinio Craveiro, Rita Freitas Show all
EUROPEAN JOURNAL OF NEUROLOGY | WILEY | Published : 2021
BACKGROUND AND PURPOSE: Reaching Expanded Disability Status Scale (EDSS) ≥7.0 represents the requirement for a wheelchair. Here we (i) assess the effect of ocrelizumab on time to EDSS ≥7.0 over the ORATORIO (NCT01194570) double-blind and extended controlled periods (DBP+ECP), (ii) quantify likely long-term benefits by extrapolating results, and (iii) assess the plausibility of extrapolations using an independent real-world cohort (MSBase registry; ACTRN12605000455662). METHODS: Post hoc analyses assessing time to 24-week confirmed EDSS ≥7.0 in two cohorts of patients with primary progressive multiple sclerosis (baseline EDSS 3.0-6.5) were investigated in ORATORIO and MSBase. RESULTS: In the ..View full abstract
This work was financially supported by F. Hoffmann-La Roche Ltd., Basel, Switzerland for the study and publication of the article.