Safety Profile and Lack of Immunogenicity of IncobotulinumtoxinA in Pediatric Spasticity and Sialorrhea: A Pooled Analysis.
all movement disorders
all pediatric
antibodies
botulinum toxin
immunogenicity
incobotulinumtoxinA
muscle spasticity
safety
sialorrhea
Journal
Toxins
ISSN: 2072-6651
Titre abrégé: Toxins (Basel)
Pays: Switzerland
ID NLM: 101530765
Informations de publication
Date de publication:
25 08 2022
25 08 2022
Historique:
received:
12
07
2022
revised:
16
08
2022
accepted:
19
08
2022
entrez:
22
9
2022
pubmed:
23
9
2022
medline:
28
9
2022
Statut:
epublish
Résumé
IncobotulinumtoxinA, a pure botulinumtoxinA formulation, is free of accessory proteins. This analysis provides pooled safety data from phase 3 trials of children/adolescents (2-17 years), investigating incobotulinumtoxinA for the treatment of spasticity associated with cerebral palsy (at doses ≤20 U/kg (max. 500 U) per injection cycle (IC) for ≤6 ICs; three trials) or sialorrhea associated with neurologic disorders (at total doses of 20-75 U per IC for ≤4 ICs; one trial) for ≤96 weeks. Safety endpoints included the incidences of different types of treatment-emergent adverse events (TEAEs) and immunogenicity. IncobotulinumtoxinA dose groups were combined. Of 1159 patients (mean age 7.3 years, 60.4% males) treated with incobotulinumtoxinA, 3.9% experienced treatment-related TEAEs, with the most common being injection site reactions (1.3%) (both indications), muscular weakness (0.7%) (spasticity), and dysphagia (0.2%) (sialorrhea). Two patients (0.2%) experienced a treatment-related treatment-emergent serious adverse event, and 0.3% discontinued the study due to treatment-related TEAEs. No botulinumtoxinA-naïve patients developed neutralizing antibodies (NAbs) after incobotulinumtoxinA. All children/adolescents with known pre-treatment status and testing positive for Nabs at final visit (
Identifiants
pubmed: 36136523
pii: toxins14090585
doi: 10.3390/toxins14090585
pmc: PMC9505819
pii:
doi:
Substances chimiques
Antibodies, Neutralizing
0
Neuromuscular Agents
0
Botulinum Toxins, Type A
EC 3.4.24.69
incobotulinumtoxinA
EC 3.4.24.69
Banques de données
ClinicalTrials.gov
['NCT01893411', 'NCT01905683', 'NCT02002884', 'NCT02270736']
EudraCT
['2012-005054-30', '2012-005055-17', '2012-005496-14', '2013-004532-30']
Types de publication
Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
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