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dc.contributor.author
Mora, Jesus S.
dc.contributor.author
Bradley, Walter G.
dc.contributor.author
Chaverri, Delia
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Hernández Barral, María
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Mascias, Javier
dc.contributor.author
Gamez, Josep
dc.contributor.author
Gargiulo Monachelli, Gisella Mariana
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dc.contributor.author
Moussy, Alain
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Mansfield, Colin D.
dc.contributor.author
Hermine, Olivier
dc.contributor.author
Ludolph, Albert C.
dc.date.available
2023-09-21T14:49:18Z
dc.date.issued
2021-07
dc.identifier.citation
Mora, Jesus S.; Bradley, Walter G.; Chaverri, Delia; Hernández Barral, María; Mascias, Javier; et al.; Long-term survival analysis of masitinib in amyotrophic lateral sclerosis; SAGE Publications; Therapeutic Advances in Neurological Disorders; 14; 7-2021; 1-16
dc.identifier.issn
1756-2856
dc.identifier.uri
http://hdl.handle.net/11336/212527
dc.description.abstract
Background: A randomized, placebo-controlled phase III study (AB10015) previously demonstrated that orally administered masitinib (4.5 mg/kg/day) slowed rate of functional decline, with acceptable safety, in amyotrophic lateral sclerosis (ALS) patients having an ALS Functional Rating Scale-revised (ALSFRS-R) progression rate from disease onset to baseline of <1.1 points/month. Here we assess long-term overall survival (OS) data of all participants from study AB10015 and test whether a signal in OS is evident in an enriched patient population similar to that prospectively defined for confirmatory study AB19001. Methods: Survival status of all patients originally randomized in AB10015 was collected from participating investigational sites. Survival analysis (using the multivariate log-rank test and Cox proportional hazards model, with stratification factors as covariates) was performed on the intention-to-treat population and enriched subgroups, which were defined according to initial randomization, baseline ALSFRS-R progression rate and baseline disease severity. Results: A significant survival benefit of 25 months (p = 0.037) and 47% reduced risk of death (p = 0.025) was observed for patients receiving 4.5 mg/kg/day masitinib (n = 45) versus placebo (n = 62) in an enriched cohort with ⩾2 on each baseline ALSFRS-R individual component score (i.e. prior to any complete loss or severe impairment of functionality) and post-onset ALSFRS-R progression rate <1.1 (i.e. exclusion of very fast progressors) [median OS of 69 versus 44 months, respectively; hazard ratio, 0.53 [95% CI (0.31–0.92)]]. This corresponds to the population enrolled in confirmatory phase III study, AB19001. Conclusions: Analysis of long-term OS (75 months average follow-up from diagnosis) indicates that oral masitinib (4.5 mg/kg/day) could prolong survival by over 2 years as compared with placebo, provided that treatment starts prior to severe impairment of functionality.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
SAGE Publications
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dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc/2.5/ar/
dc.subject
CLINICAL TRIALS
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MASITINIB
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THERAPY
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TYROSINE KINASE INHIBITOR
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Neurología Clínica
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dc.subject.classification
Medicina Clínica
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dc.subject.classification
CIENCIAS MÉDICAS Y DE LA SALUD
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dc.title
Long-term survival analysis of masitinib in amyotrophic lateral sclerosis
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2023-09-18T13:37:51Z
dc.identifier.eissn
1756-2864
dc.journal.volume
14
dc.journal.pagination
1-16
dc.journal.pais
Alemania
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dc.description.fil
Fil: Mora, Jesus S.. No especifíca;
dc.description.fil
Fil: Bradley, Walter G.. University of Miami; Estados Unidos
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Fil: Chaverri, Delia. No especifíca;
dc.description.fil
Fil: Hernández Barral, María. No especifíca;
dc.description.fil
Fil: Mascias, Javier. No especifíca;
dc.description.fil
Fil: Gamez, Josep. Universitat Autònoma de Barcelona; España
dc.description.fil
Fil: Gargiulo Monachelli, Gisella Mariana. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET; Argentina
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Fil: Moussy, Alain. No especifíca;
dc.description.fil
Fil: Mansfield, Colin D.. No especifíca;
dc.description.fil
Fil: Hermine, Olivier. No especifíca;
dc.description.fil
Fil: Ludolph, Albert C.. Universitat Ulm; Alemania
dc.journal.title
Therapeutic Advances in Neurological Disorders
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1177/17562864211030365
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