| Title: |
Application of the ENCALS predictive survival model in assessing the effect of the 24/44 inclusion criteria in FORTITUDE-ALS |
| Authors: |
Simkins Lead,Tyrell; Shefner,Jeremy M; Kupfer,Stuart; Malik,Fady I; Meng,Lisa; Rudnicki,Stacy A; Wei,Jenny; van Eijk, Ruben Pa; Projectafdeling ALS; Brain |
| Publication Year: |
2025 |
| Subject Terms: |
ALS; ENCALS survival prediction model; FORTITUDE-ALS; clinical trials design; Journal Article |
| Description: |
FORTITUDE-ALS was a study evaluating reldesemtiv in people living with ALS. Post-hoc analysis identified larger treatment effects in those with symptom onset ≤24 months and baseline ALSFRS-R ≤ 44 (24/44 criteria). Using the ENCALS risk score (RS), we analyzed how the 24/44 criteria changed the eligible population. Of the 272 participants meeting the 24/44 criteria, 73% had very short to intermediate RS compared to 18% not meeting the criteria. Though the 24/44 criteria enriched the FORTITUDE-ALS population with rapidly progressing patients, they did not completely exclude all patients with a very long predicted survival. |
| Document Type: |
manuscript |
| File Description: |
application/pdf |
| Language: |
English |
| ISSN: |
2214-3599 |
| Relation: |
https://dspace.library.uu.nl/handle/1874/465996 |
| Availability: |
https://dspace.library.uu.nl/handle/1874/465996 |
| Rights: |
info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.B6A74C03 |
| Database: |
BASE |