Risk of requiring a wheelchair in primary progressive multiple sclerosis

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 lo...

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Autores: Montalban, Xavier|||0000-0002-0098-9918, Butzkueven, Helmut|||0000-0003-3940-8727, Spelman, Tim|||0000-0001-9204-3216, Horakova, Dana|||0000-0003-1915-0036, Hughes, Stella, Solaro, Claudio Marcello|||0000-0002-6713-4623, Izquierdo, Guillermo|||0000-0002-6340-5609, Kubala Havrdova, Eva|||0000-0002-9543-4359, Grand'Maison, Francois, Prat, Alexandre|||0000-0001-6188-0580, Girard, Marc, Hupperts, Raymond, Onofrj, Marco|||0000-0002-0480-2495, Lugaresi, Alessandra|||0000-0003-2902-5589, Taylor, Bruce, Giovannoni, Gavin|||0000-0001-9995-1700, Kappos, Ludwig|||0000-0003-4175-5509, Hauser, Stephen L.|||0000-0002-4932-4001, Craveiro, Licinio|||0000-0002-8841-8035, Freitas, Rita, Model, Fabian, Overell, James|||0000-0002-3998-9819, Muros-Le Rouzic, Erwan|||0000-0002-8925-0481, Sauter, Annette, Wang, Qing, Wormser, David, Wolinsky, Jerry S.|||0000-0002-8197-2762
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:275797
Acceso en línea:https://ddd.uab.cat/record/275797
https://dx.doi.org/urn:doi:10.1111/ene.14824
Access Level:acceso abierto
Palabra clave:Disease progression
Ocrelizumab
Primary progressive multiple sclerosis
Wheelchair
Descripción
Sumario: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.

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