Tolerability, administration burden, and patient-reported experience of riluzole formulations in ALS: a longitudinal real-world study
Abstract
IntroductionRiluzole is available as tablets (T), oral suspension (OS), and orodispersible film (OF), but comparative real-world data on tolerability, administration burden, and patient-reported experience are limited. MethodsIn this longitudinal study, 138 patients with amyotrophic lateral sclerosis (ALS) were evaluated at baseline (79 OF, 21 OS, 38 T) and 97 were reassessed after a median of 3.9 months. ResultsOS-treated patients had longer disease duration and greater functional impairment than OF or T (p < 0.001), reflecting preferential use in more advanced disease. Oral numbness was more frequent with OF than OS or T (54.4% vs. 14.3% vs. 13.2%; p < 0.001) and decreased during follow-up (42.3%–28.9%; p = 0.016), partly because patients reporting it switched away from OF. OF use (adjusted OR 10.55 vs. T, p < 0.001) and female sex (OR 2.59, p = 0.035) were independently associated with higher, and older age with lower, odds of an adverse event at baseline (OR 0.43 per 10-year increment, p < 0.001); at 3-month follow-up, OF remained the strongest formulation-related predictor (OR 5.42, p = 0.024), while an adverse event already present at baseline was itself the strongest predictor of one at follow-up (OR 5.11, p = 0.006). Dysphagia was associated with tablet manipulation (OR 7.19, p = 0.034). Differences among formulations concerned packaging convenience and independent self-administration rather than overall satisfaction, and lower disease severity was weakly associated with higher satisfaction regardless of formulation (ρ = 0.21, p = 0.015). Formulation persistence among reassessed patients was high (85.6%), and most patients who left OF had anticipated this intention at baseline. DiscussionThe three riluzole formulations are used in clinically distinct ALS populations and differ in tolerability and usability rather than overall satisfaction, and a prior adverse event marks persisting risk. Formulation choice should be individualized and periodically reassessed as disease progresses.
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BibTeX
@article{senerchia2026tolerability,
title = {{Tolerability, administration burden, and patient-reported experience of riluzole formulations in ALS: a longitudinal real-world study}},
author = {Gianmaria Senerchia and Lucia Aruta and Myriam Spisto and Valentina Virginia Iuzzolino and Fabiana Panico and Rosanna Balzano and Maria Esposito and Raffaele Dubbioso},
journal = {Frontiers in Pharmacology},
year = {2026},
month = nov,
doi = {10.3389/fphar.2026.1980433},
url = {https://www.frontiersin.org/articles/10.3389/fphar.2026.1980433},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Tolerability, administration burden, and patient-reported experience of riluzole formulations in ALS: a longitudinal real-world study
AU - Gianmaria Senerchia
AU - Lucia Aruta
AU - Myriam Spisto
AU - Valentina Virginia Iuzzolino
AU - Fabiana Panico
AU - Rosanna Balzano
AU - Maria Esposito
AU - Raffaele Dubbioso
PY - 2026
DA - 2026/11/09
JO - Frontiers in Pharmacology
DO - 10.3389/fphar.2026.1980433
UR - https://www.frontiersin.org/articles/10.3389/fphar.2026.1980433
AB - IntroductionRiluzole is available as tablets (T), oral suspension (OS), and orodispersible film (OF), but comparative real-world data on tolerability, administration burden, and patient-reported experience are limited. MethodsIn this longitudinal study, 138 patients with amyotrophic lateral sclerosis (ALS) were evaluated at baseline (79 OF, 21 OS, 38 T) and 97 were reassessed after a median of 3.9 months. ResultsOS-treated patients had longer disease duration and greater functional impairment than OF or T (p < 0.001), reflecting preferential use in more advanced disease. Oral numbness was more frequent with OF than OS or T (54.4% vs. 14.3% vs. 13.2%; p < 0.001) and decreased during follow-up (42.3%–28.9%; p = 0.016), partly because patients reporting it switched away from OF. OF use (adjusted OR 10.55 vs. T, p < 0.001) and female sex (OR 2.59, p = 0.035) were independently associated with higher, and older age with lower, odds of an adverse event at baseline (OR 0.43 per 10-year increment, p < 0.001); at 3-month follow-up, OF remained the strongest formulation-related predictor (OR 5.42, p = 0.024), while an adverse event already present at baseline was itself the strongest predictor of one at follow-up (OR 5.11, p = 0.006). Dysphagia was associated with tablet manipulation (OR 7.19, p = 0.034). Differences among formulations concerned packaging convenience and independent self-administration rather than overall satisfaction, and lower disease severity was weakly associated with higher satisfaction regardless of formulation (ρ = 0.21, p = 0.015). Formulation persistence among reassessed patients was high (85.6%), and most patients who left OF had anticipated this intention at baseline. DiscussionThe three riluzole formulations are used in clinically distinct ALS populations and differ in tolerability and usability rather than overall satisfaction, and a prior adverse event marks persisting risk. Formulation choice should be individualized and periodically reassessed as disease progresses.
SN - 1663-9812
ER -