EDSS (Expanded Disability Status Scale)
Neurology· appears in 58+ cited findings in this library
What it is and how the reviews use it
The Expanded Disability Status Scale (EDSS) is a rating scale used to assess disability in multiple sclerosis. In the context of regulatory review documents, the EDSS score range for inclusion in studies has been noted as 0 to 5.5 (Novartis AG — Kesimpta FDA Review, p.121; Roche Holding AG — Ocrevus FDA Review, p.36) and 0.0 to 6.0 (Biogen Inc. — Vumerity FDA Review, p.52, p.69).
Regulatory reviews in this library utilize EDSS to characterize patient populations and as an endpoint. For instance, the mean baseline EDSS score for the ALKS8700 arm in Part A of ALK8700-A302 was 2.8 (Biogen Inc. — Vumerity FDA Review, p.72). The overall baseline EDSS mean was 2.9 in a review for Briumvi (TG THERAPEUTICS, INC — Briumvi FDA Review, p.67). Additionally, the MSWS-12 score difference between EDSS 5.5 and 6.5 was 6.7 points in a review for Fampyra (Merz — Fampyra EMA EPAR public assessment report, p.73).
Real examples — cited to the source page
| Vumerity | Mean baseline EDSS score for ALKS8700 arm in Part A of ALK8700-A302 | 2.8 | Vumerity FDA Review, p.72 |
| Vumerity | Mean baseline EDSS score for DMF arm in Part A of ALK8700-A302 | 3.0 | Vumerity FDA Review, p.72 |
| Vumerity | EDSS score range for de novo subjects in ALK8700-A301 | 0.0 to 6.0 | Vumerity FDA Review, p.52 |
| Kesimpta | EDSS score range for inclusion | 0 to 5.5 | Kesimpta FDA Review, p.121 |
| Vumerity | Baseline EDSS score range for inclusion in ALK8700-A302 | 0.0 to 6.0 | Vumerity FDA Review, p.69 |
| Briumvi | EDSS range | 0-5.5 | Briumvi FDA Review, p.29 |
| Briumvi | Baseline EDSS mean (total) | 2.9 | Briumvi FDA Review, p.67 |
| Ocrevus | EDSS score range for inclusion criteria | 0 to 5.5 | Ocrevus FDA Review, p.36 |
Different drugs were studied in different trials — these values are not head-to-head comparisons.
Explore the full evidence
Every EDSS finding in the library — searchable and answerable in plain language — is in the Neurology research library →
Figures are as stated in the cited source documents. Educational reference only — not medical or investment advice.