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

Autor: Delgado MR; Department of Neurology, University of Texas Southwestern Medical Center, Scottish Rite Hospital for Children, Dallas, TX, USA., Tilton A; Department of Neurology, LSUHSC and Children's Hospital New Orleans, New Orleans, LA, USA., Carranza-Del Río J; Hospital San José Celaya, Celaya, Guanajuato, Mexico., Dursun N; Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Kocaeli University, Kocaeli, Turkey., Bonikowski M; Mazovian Neuropsychiatry Center, Zagórze, nr Warsaw, Poland., Aydin R; Department of Physical Medicine and Rehabilitation, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey., Maciag-Tymecka I; Rehabilitation Center KROK PO KROKU, Gdansk, Poland., Oleszek J; Department of Physical Medicine and Rehabilitation, University of Colorado and Children's Hospital Colorado, Aurora, CO, USA., Dabrowski E; Department of Pediatric Physical Medicine and Rehabilitation, Beaumont Health, Oakland University School of Medicine, Grosse Pointe, MI, USA., Grandoulier AS; Atlanstat consultant for Ipsen Pharma, Les Ulis, France., Picaut P; Ipsen Pharma, Cambridge, MA, USA.
Jazyk: angličtina
Zdroj: Developmental medicine and child neurology [Dev Med Child Neurol] 2021 May; Vol. 63 (5), pp. 592-600. Date of Electronic Publication: 2020 Nov 18.
DOI: 10.1111/dmcn.14733
Abstrakt: 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.
(© 2020 The Authors. Developmental Medicine & Child Neurology published by John Wiley & Sons Ltd on behalf of Mac Keith Press.)
Databáze: MEDLINE
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