Abstract
Objective: To review pediatric safety data from randomized controlled trials of abobotulinumtoxinA by age group.
Background: AbobotulinumtoxinA has recently been approved for the treatment of lower limb spasticity in children aged 2 years and older.
Design/Methods: This was a pooled analysis of safety data from 4 controlled clinical trials of abobotulinumtoxinA in children aged 2–17 years old with lower limb spasticity due to cerebral palsy. Individual adverse event (AE) data for each study were pooled to form one database. Descriptive pooled safety data are presented for preschool aged children (aged 2–5 years) and older children (elementary school [6–9 years old] and middle/high school [10+ years]).
Results: The preschool group included 299 children aged 2–5 years (abobotulinumtoxinA=195, placebo=104), the elementary-school group included 134 children aged 6–9 years (abobotulinumtoxinA =87, placebo=47) and the middle/high-school group included 43 children aged 10+ years (abobotulinumtoxinA=30, placebo=13). Across all age groups most AEs were related to childhood illness (e.g. respiratory tract infection, nasopharyngitis, pyrexia); rates of AEs (abobotulinumtoxinA vs. placebo) were: Preschool (60.5% Vs 52.9%), elementary-school (58.6% Vs 36.2%), middle/high-school (40.0% Vs 46.2%). Rates of TEAEs considered related to abobotulinumtoxinA treatment were low across all age groups: Preschool (14.9% Vs 8.7%), elementary-school (11.5% Vs 2.1%), middle/high-school (6.7% Vs 15.4%). Serious AEs were reported in 10 preschool aged children (n=5 in both groups), 4 elementary-school aged children (abobotulinumtoxinA =3, placebo=1) and 1 middle/high school aged child (abobotulinumtoxinA =1). Of these, the only serious AE considered to be treatment related occurred in the middle/high school aged child (moderate dysarthria & moderate muscular weakness following injection of 30U/kg in hamstrings & adductor muscles). This was also the only treatment-related AE that led to premature study withdrawal. No unexpected AEs were reported in any age group.
Conclusions: These analyses indicate a consistently well-tolerated profile of abobotulinumtoxinA across age groups.
Study Supported by: Ipsen Pharma
Disclosure: Dr. Tilton has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Ipsen Pharma. Dr. Tilton has received research support from Ipsen Pharma. Dr. Matthews has received research support from Ipsen Pharma. Dr. Gormley has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Ipsen Pharma. Dr. Gormley has received research support from Ipsen Pharma. Dr. Suarez-Zambrano has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Ipsen. Dr. Picaut has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Ipsen. Dr. Delgado has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Ipsen Pharma. Dr. Delgado has received research support from Ipsen Pharma.
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