Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Pediatric Upper and Lower Limb Spasticity: Results From 2 Open-Label, Long-term Extension Trials

Document Type

Article

Abstract

AimTo evaluate the efficacy and safety of onabotulinumtoxinA for treating upper and lower limb spasticity among pediatric patients in 2 open-label extension trials.MethodsPatients aged <18 years received ≤5 doses of onabotulinumtoxinA (maximum: 8 U/kg [300 U], cycle 1; 10 U/kg [340 U], cycles 2-5) over 60 weeks. Week 6 efficacy endpoints included mean change from baseline in Modified Ashworth Scale-Bohannon and Modified Tardieu Scale scores, and mean Clinical Global Impression of Overall Change score. Adverse events and laboratory assessments of bone health were monitored.ResultsA total of 580 patients received onabotulinumtoxinA. Modified Ashworth Scale-Bohannon change from baseline ranged from -1.01 to -1.9. Modified Tardieu Scale change from baseline was 13.6 to 18.1 (ankle), 25.8 to 44.1 (elbow), and -5.0 to -26.3 (wrist). Clinical Global Impression of Overall Change scores were 1.5 to 2.2. The most common treatment-emergent adverse events were upper respiratory tract infection (16.9%) and nasopharyngitis (15.7%).InterpretationRepeat administration of onabotulinumtoxinA was safe and efficacious for treating upper and lower limb spasticity in children.

Medical Subject Headings

Humans; Muscle Spasticity (drug therapy); Botulinum Toxins, Type A (therapeutic use, adverse effects, administration & dosage); Male; Female; Child; Lower Extremity (physiopathology); Adolescent; Treatment Outcome; Neuromuscular Agents (therapeutic use, adverse effects); Upper Extremity (physiopathology); Child, Preschool; Cerebral Palsy (drug therapy)

Publication Date

3-1-2025

Publication Title

Journal of child neurology

E-ISSN

1708-8283

Volume

40

Issue

3

First Page

168

Last Page

179

PubMed ID

39716821

Digital Object Identifier (DOI)

10.1177/08830738241288431

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