Risk of requiring a wheelchair in primary progressive multiple sclerosis: Data from the ORATORIO trial and the MSBase registry.
Eur J Neurol
; 29(4): 1082-1090, 2022 04.
Article
in En
| MEDLINE
| ID: mdl-33724638
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Wheelchairs
/
Multiple Sclerosis, Chronic Progressive
/
Multiple Sclerosis
Type of study:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
Limits:
Humans
Language:
En
Journal:
Eur J Neurol
Journal subject:
NEUROLOGIA
Year:
2022
Type:
Article
Affiliation country:
Australia