Session Information
Session Title: Research Spotlight: Pediatric Rehabilitation
Session Time: None. Available on demand.
Disclosures: Edward Dabrowski, MD: Allergan (Products/Services: No) (Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness)Ipsen (Products/Services: No) (Consultant/Advisory Board, Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received, Speaker/Honoraria includes speakers bureau, symposia, and expert witness)Merz (Products/Services: No) (Consultant/Advisory Board, Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received)World wide medical (Products/Services: No) (Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness)
Objective: The objective of this study was to assess the efficacy and safety of incobotulinumtoxinA for upper- and combined upper- and lower-limb spasticity in ambulant and non-ambulant children and adolescents with cerebral palsy (CP).
Design: XARA (NCT02002884) was a randomized Phase 3 study with a double-blind main period (MP) and an open-label extension (OLEX) period.Setting : The study was conducted at 28 sites worldwide.Participants : Patients 2–17 years of age with uni- or bilateral CP and Ashworth Scale (AS) scores ≥2 in main clinical target patterns, flexed elbow and/or flexed wrist, were enrolled.
Interventions: In the MP, patients were randomized (2:1:1) to 3 incobotulinumtoxinA dose groups (8, 6, 2 U/kg body weight [BW]; maximum 200, 150, 50 U/upper limb) with additional lower-limb injections (total body dose ≤16–20 U/kg BW [≤400–500 U], depending on Gross Motor Function Classification System [GMFCS] level). Patients received 3 further injection cycles (ICs) in the OLEX, with doses per the 8 U/kg BW group.
Main Outcome Measures: Outcomes included AS, Global Impression of Change Scale (GICS), and adverse events (AEs).
Results: 350 patients (62.9% male, mean [SD] age 7.3 [4.4] years old, BW 25.0 [15.0] kg, 30.9% GMFCS IV–V) were treated; 281 (80.3%) completed the study, receiving 4 incobotulinumtoxinA ICs. In the MP, AS scores for the upper-limb main clinical pattern improved significantly from baseline to Week 4 (p < 0.0001, MMRM), with a significantly greater improvement in the 8 U/kg versus the 2 U/kg dose group (p=0.017, MMRM). Improvements were observed in all treated upper- and lower-limb clinical patterns and across all OLEX ICs. GICS scores confirmed global improvements in upper- and lower-limb spasticity but did not differ between dose groups. There was no increased incidence of AEs with increasing dose or repeated treatment.Conclusions: Data provide evidence for sustained efficacy and safety of multi-pattern incobotulinumtoxinA treatment of spasticity in patients with CP (GMFCS I–V).
Level of Evidence: Level I
To cite this abstract in AMA style:
Dabrowski E, Gaebler-Spira D, Chambers H, Banach M, Kanovsky P, Heinen F. Efficacy and Safety of IncobotulinumtoxinA for Upper- or Combined Upper- and Lower-limb Spasticity in Children and Adolescents with Cerebral Palsy: Results of the Phase 3 XARA Study [abstract]. PM R. 2021; 13(S1)(suppl 1). https://pmrjabstracts.org/abstract/efficacy-and-safety-of-incobotulinumtoxina-for-upper-or-combined-upper-and-lower-limb-spasticity-in-children-and-adolescents-with-cerebral-palsy-results-of-the-phase-3-xara-study/. Accessed May 11, 2025.« Back to AAPM&R Annual Assembly 2021
PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/efficacy-and-safety-of-incobotulinumtoxina-for-upper-or-combined-upper-and-lower-limb-spasticity-in-children-and-adolescents-with-cerebral-palsy-results-of-the-phase-3-xara-study/