Peer-reviewed article
Efficacy and safety of abobotulinumtoxinA for upper limb spasticity in children with cerebral palsy: a randomized repeat‐treatment study
Mauricio R. Delgado, Ann Henderson Tilton, Jorge Carranza-del Río, Nigar Dursun, Marcin Bonikowski et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study tested whether injections of abobotulinumtoxinA, a muscle-relaxing treatment, could reduce arm stiffness in children with cerebral palsy. Children aged 2-17 years received either a low, medium, or high dose of the injection along with home exercises. The medium and high doses significantly reduced arm stiffness compared to the low dose, and benefits lasted when children received repeat treatments over one year. The treatment was generally safe, with only occasional mild muscle weakness.
Key points
- Children receiving 8U/kg or 16U/kg abobotulinumtoxinA had significantly lower Modified Ashworth scale scores at week 6 compared to the 2U/kg control group
- All treatment groups achieved their physician-defined treatment goals at least as expected
- Therapeutic benefits were sustained across repeat treatment cycles 2-4
- Muscular weakness was the only reported treatment-related adverse event, occurring in 4.3%, 5.7%, and 1.4% of children in each group respectively
- 210 children were enrolled and 209 complied with the home exercise therapy program
Limitations
The study only evaluated upper limb spasticity in children with cerebral palsy and cannot tell us about effects on lower limbs or other neurological conditions. The one-year follow-up period and specific dosing regimens tested may not represent all clinical contexts or longer-term outcomes.
Abstract
AIM: To assess the efficacy and safety of repeat abobotulinumtoxinA injections in reducing upper limb spasticity in children with cerebral palsy (CP). METHOD: This was a double-blind, repeat-cycle study (NCT02106351) in children with CP (2-17y). Children were randomized to receive 2U/kg (control), 8U/kg, or 16U/kg abobotulinumtoxinA injections into the target muscle group (wrist or elbow flexors) and additional muscles alongside occupational therapy via a home-exercise therapy program (HETP; minimum five 15min sessions/wk). Children received 8U/kg or 16U/kg plus HETP in cycles 2 to 4. RESULTS: During cycle 1, 210 children (126 males, 84 females; mean age [SD] 9y [4y 5mo], range 2-17y; n=70/group) had at least one upper limb abobotulinumtoxinA injection and 209 complied with the HETP. At week 6 of cycle 1, children in the 8U/kg or 16U/kg groups had significantly lower Modified Ashworth scale scores versus the 2U/kg group (primary outcome: treatment differences of -0.4 [p=0.012] and -0.7 [p<0.001] respectively). All groups improved on Physician Global Assessment and children in all groups achieved their treatment goals at least as expected. Therapeutic benefits were sustained during cycles 2 to 4; muscular weakness was the only treatment-related adverse event reported in at least one child/group (4.3% and 5.7% vs 1.4% respectively). INTERPRETATION: Treatment with 8U/kg or 16U/kg abobotulinumtoxinA significantly reduced upper limb spasticity versus the 2U/kg control dose. Therapeutic benefits of abobotulinumtoxinA plus HETP were sustained with repeat treatment cycles. WHAT THIS PAPER ADDS: AbobotulinumtoxinA injections significantly reduced upper limb spasticity in children with cerebral palsy. Children treated with abobotulinumtoxinA and targeted home exercises showed global improvement and goal attainment. Benefits were sustained over 1 year with repeat cycles of abobotulinumtoxinA and home exercises. AbobotulinumtoxinA injections into the upper limb were well tolerated over 1 year.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- AbobotulinumtoxinA injections at 8U/kg or 16U/kg into target muscles (wrist or elbow flexors) combined with home exercise therapy program (minimum five 15-minute sessions per week)
- Population
- 210 children aged 2-17 years with cerebral palsy and upper limb spasticity (mean age 9 years; 126 male, 84 female)
Key finding
At week 6 of cycle 1, Modified Ashworth scale scores were significantly lower in 8U/kg group (treatment difference -0.4, p=0.012) and 16U/kg group (treatment difference -0.7, p<0.001) compared to 2U/kg control