Efficacy and safety of abobotulinumtoxinA for upper limb spasticity in children with cerebral palsy: a randomized repeat-treatment study.

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.

• Authors: Mauricio R Delgado, Ann Tilton, Jorge Carranza-Del Río, Nigar Dursun, Marcin Bonikowski, Resa Aydin, Iwona Maciag-Tymecka, Joyce Oleszek, Edward Dabrowski, Anne-Sophie Grandoulier, Philippe Picaut, Dysport in PUL study group
• Journal: Developmental medicine and child neurology (Dev Med Child Neurol) Vol. 63 Issue 5 Pg. 592-600 (05 2021) ISSN: 1469-8749 [Electronic] England
• PMID: 33206382 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: © 2020 The Authors. Developmental Medicine & Child Neurology published by John Wiley & Sons Ltd on behalf of Mac Keith Press.

Chemical References

• Neuromuscular Agents
• Botulinum Toxins, Type A
• abobotulinumtoxinA

Topics

• Adolescent
• Botulinum Toxins, Type A (adverse effects, therapeutic use)
• Cerebral Palsy (drug therapy, physiopathology)
• Child
• Child, Preschool
• Double-Blind Method
• Female
• Humans
• Injections, Intramuscular
• Male
• Muscle Spasticity (drug therapy, physiopathology)
• Neuromuscular Agents (adverse effects, therapeutic use)
• Treatment Outcome
• Upper Extremity (physiopathology)