| Title: |
Risk of requiring a wheelchair in primary progressive multiple sclerosis : Data from the ORATORIO trial and the MSBase registry |
| Authors: |
Montalban, Xavier; Butzkueven, Helmut; Spelman, Tim; Horakova, Dana; Hughes, Stella; Solaro, Claudio Marcello; Izquierdo, Guillermo; Kubala Havrdova, Eva; Grand'Maison, Francois; Prat, Alexandre; Girard, Marc; Hupperts, Raymond; Onofrj, Marco; Lugaresi, Alessandra; Taylor, Bruce; Giovannoni, Gavin; Kappos, Ludwig; Hauser, Stephen L.; Craveiro, Licinio; Freitas, Rita; Model, Fabian; Overell, James; Muros-Le Rouzic, Erwan; Sauter, Annette; Wang, Qing; Wormser, David; Wolinsky, Jerry S.; MSBase Study Group; Universitat Autònoma de Barcelona |
| Publication Year: |
2022 |
| Collection: |
Universitat Autònoma de Barcelona: Dipòsit Digital de Documents de la UAB |
| Subject Terms: |
Disease progression; Ocrelizumab; Primary progressive multiple sclerosis; Wheelchair |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| ISSN: |
14681331 |
| Relation: |
European Journal of Neurology; Vol. 29 Núm. 4 (2022), p. 1082-1090; https://ddd.uab.cat/record/275797; urn:10.1111/ene.14824; urn:oai:ddd.uab.cat:275797; urn:pure_id:319809702; urn:scopus_id:85105017493; urn:pmid:33724638; urn:pmcid:PMC9292576; urn:articleid:14681331v29n4p1082; urn:oai:pubmedcentral.nih.gov:9292576 |
| Availability: |
https://ddd.uab.cat/record/275797 |
| Rights: |
open access ; Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. ; https://creativecommons.org/licenses/by-nc/4.0/ |
| Accession Number: |
edsbas.FA3CDB4 |
| Database: |
BASE |