Application of the ENCALS predictive survival model in assessing the effect of the 24/44 inclusion criteria in FORTITUDE-ALS
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.
Authors
- Stacy A. Rudnicki (ORCID: https://orcid.org/0000-0002-3499-5208)
- Jeremy M. Shefner (ORCID: https://orcid.org/0000-0001-5067-5602)
- Tyrell Simkins (ORCID: https://orcid.org/0000-0002-6063-174X)
- Jenny Wei (ORCID: https://orcid.org/0009-0000-5828-5705)
- Ruben P. A. van Eijk (ORCID: https://orcid.org/0000-0002-7132-5967)
- Fady I. Malik (ORCID: https://orcid.org/0000-0002-5597-5759)
- Stuart Kupfer (ORCID: https://orcid.org/0000-0002-5469-1287)
- Lisa Meng (ORCID: https://orcid.org/0000-0003-0229-1131)
Institutions
- Creighton University (US)
- Barrow Neurological Institute (US)
- University of Arizona (US)
- University Medical Center Utrecht (NL)
- Cytokinetics (United States) (US)
Publication Details
- Journal
- Journal of Neuromuscular Diseases
- Published
- 2025-05-05
- DOI
- https://doi.org/10.1177/22143602251336058
- Primary Topic
- Amyotrophic Lateral Sclerosis Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00