Risk of requiring a wheelchair in primary progressive multiple sclerosis: Data from the ORATORIO trial and the MSBase registry
Year: 2021
Type: article
Abstract: 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 ORATORIO DBP+ECP, ocrelizumab reduced the risk of 24-week confirmed EDSS ≥7.0 (hazard ratio = 0.54, 95% confidence interval [CI]: 0.31-0.92; p = 0.022). Extrapolated median time to 24-week confirmed EDSS ≥7.0 was 12.1 and 19.2 years for placebo and ocrelizumab, respectively (7.1-year delay [95% CI: -4.3 to 18.4]). In MSBase, the median time to 24-week confirmed EDSS ≥7.0 was 12.4 years. CONCLUSIONS: Compared with placebo, ocrelizumab significantly delayed time to 24-week confirmed wheelchair requirement in ORATORIO. The plausibility of the extrapolated median time to reach this milestone in the placebo group was supported by observed real-world data from MSBase. Extrapolated benefits for ocrelizumab over placebo could represent a truly meaningful delay in loss of ambulation and independence.
Source: European Journal of Neurology
DOI: 10.1111/ene.14824
Authors: Helmut Butzkueven, Tim Spelman, Dana Horakova, Stella Hughes, Claudio Solaro, Guillermo Izquierdo, Eva Kubala Havrdová, Francois Grand'Maison, Alexandre Prat, Marc Girard, Raymond Hupperts, Marco Onofrj, Alessandra Lugaresi, Bruce Taylor, the MSBase Study Group, Gavin Giovannoni, Ludwig Kappos, Stephen L. Hauser, Xavier Montalban, Licinio Craveiro, Rita Freitas, Fabian Model, James Overell, Erwan Muros‐Le Rouzic, Annette Sauter, Qing Wang, David Wormser, Jerry S. Wolinsky
Institutions: Monash University, The Royal Melbourne Hospital, The University of Melbourne, Charles University, General University Hospital in Prague, Belfast Health and Social Care Trust, Craigavon Area Hospital, Hospitales Nisa, Centre Hospitalier de l’Université de Montréal, Université de Montréal, Zuyderland Medisch Centrum, University of Chieti-Pescara, Istituto delle Scienze Neurologiche di Bologna, University of Bologna, Royal Hobart Hospital, Queen Mary University of London, University of Basel, University Hospital of Basel, University of California, San Francisco, Vall d'Hebron Hospital Universitari, Centre d'Esclerosi Múltiple de Catalunya, F. Hoffmann-La Roche AG, The University of Texas Health Science Center at Houston
Language: English
Subfield: Clinical Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,100
Award: G5849448840
OpenAlex ID: W3136701550