Evidence map›Paper›PMID 34457038›Full record

ArticleTherapeutic advances in neurological disorders2021

Long-term survival analysis of masitinib in amyotrophic lateral sclerosis.

Jesus S Mora, Walter G Bradley, Delia Chaverri, María Hernández-Barral, Javier Mascias, Josep Gamez, Gisella M Gargiulo-Monachelli, Alain Moussy, Colin D Mansfield, Olivier Hermine and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Therapeutic advances in neurological disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02588677 (Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib), which is not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
5.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02588677 phase2 / phase3completednot on this map

Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib

TypeinterventionalSponsorAB ScienceRan2013 to 2018Enrolled394ConditionsAmyotrophic Lateral Sclerosis (ALS)ArmsMasitinib (4.5), Riluzole, Placebo, Masitinib (3.0)
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 63 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Gut microbiota immune cross-talk in amyotrophic lateral sclerosis.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2024
    Review
  13. Article
  14. Review
  15. Article
  16. Masitinib as a neuroprotective agent: a scoping review of preclinical and clinical evidence.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Article
  17. Article
  18. Molecular mechanisms and therapeutic strategies for neuromuscular diseases.Cellular and molecular life sciences : CMLS · 2024
    Review
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 5 countries.

Jesus S MoraALS Unit, Hospital San Rafael, Madrid, Spain.
Walter G BradleyDepartment of Neurology, University of Miami School of Medicine, Miami, FL, USA.
Delia ChaverriALS Unit, Department of Neurology, University Hospital La Paz-Carlos III, Madrid, Spain.
María Hernández-BarralALS Unit, Department of Neurology, University Hospital La Paz-Carlos III, Madrid, Spain.
Javier MasciasALS Unit, Department of Neurology, University Hospital La Paz-Carlos III, Madrid, Spain.
Josep GamezNeurology Department, GMA Clinic, Autonomous University of Barcelona, European Reference Network on Rare Neuromuscular Diseases (ERN EURO-NMD), Barcelona, Spain.ORCID https://orcid.org/0000-0003-3127-7486
Gisella M Gargiulo-MonachelliHospital Universitario CEMIC-CONICET Buenos Aires, Argentina.
Alain MoussyAB Science, Paris, France.
Colin D MansfieldAB Science, Paris, France.ORCID https://orcid.org/0000-0001-9175-5051
Olivier HermineDepartment of Hematology, Necker Hospital, University of Paris, 149 Rue de Sèvres, Paris 75015, France.
Albert C LudolphDepartment of Neurology, University of Ulm, Oberer Eselsberg 45, Ulm 89081, Germany.
Hospital Universitario La Paz · ESAB Science (France) · FRConsejo Nacional de Investigaciones Científicas y Técnicas · ARHôpital Necker-Enfants Malades · FRHospital Universitario San Rafael · ESUniversitat Autònoma de Barcelona · ESUniversität Ulm · DEUniversity of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA 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.

methodsSurvival 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.

resultsA significant survival benefit of 25 months (

conclusionsAnalysis 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.This trial was registered at www.ClinicalTrials.gov under identifier NCT02588677 (28 October 2015).

Indexed as

clinical trialsmasitinibtherapytyrosine kinase inhibitor

Identifiers

PMID34457038
PMCPMC8388186
OpenAlexW3183535210

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.