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.
Original language | English (US) |
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Pages (from-to) | 592-600 |
Number of pages | 9 |
Journal | Developmental Medicine and Child Neurology |
Volume | 63 |
Issue number | 5 |
DOIs | |
State | Published - May 2021 |
Funding
The members of the Dysport in PUL study group are as follows: Anne Renders, Josef Kraus, Eduard Minks, Uri Givon, Yair Sadaka, Daniel Weigl, Aviva Fattal-Valevski, Hilla Ben-Pazi, Jorge Carranza-del Río, Jose Alberto Moreno Gonzalez, Elsa Maria Ivon Perez Flores, Marcin Bonikowski, Marek Jozwiak, Roser Garreta Figuera, Xenia Alonso Curco, Mar Melendez Plumed, Nigar Dursun, Resa Aydin, Ozlen Peker, Mauricio R Delgado, Joyce Oleszek, Ann Tilton, John P Phillips, Gadi Revivo, Sarah H Evans, Edward A Wright, Jenny Lupovici Wilson, Edward Dabrowski, Heakyung Kim, Shawn Aylward, Mark E Gormley. The authors thank all children and their families involved in the study, as well as the investigators and research staff in participating institutions. We also thank Anita Chadha-Patel, PhD, of ACP Clinical Communications Ltd (Hertfordshire, UK) for providing medical writing support, which was funded by Ipsen (Paris, France) in accordance with Good Publication Practice guidelines.
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
- Developmental Neuroscience
- Clinical Neurology