Developmental Medicine and Child Neurology
Introduction: This pooled analysis assessed the efficacy of incobotulinumtoxinA for lower-limb (LL) and upper-limb (UL) spasticity in children and adolescents with cerebral palsy (CP) using data from the first controlled injection cycle of 2 large Phase 3 studies, TIM (NCT01893411) and XARA (NCT02002884).
Methods: Ambulant and non-ambulant pediatric patients with spasticity due to CP (2–17 years of age; uni- or bilateral CP; Ashworth Scale [AS] score ≥2 in clinical patterns for treatment) were enrolled. Patients were randomized (2:1:1) to 3 incobotulinumtoxinA dose groups: 8, 6, 2 U/kg body weight (BW), maximum 200, 150, 50 U per LL clinical pattern in TIM and per UL in XARA. Additional multipattern treatment was allowed in both studies with total body doses up to 16–20 U/kg BW (≤400–500 U) depending on study and Gross Motor Function Classification System (GMFCS) levels I-V. Changes from baseline in AS score and Global Impression of Change Scale (GICS) scores at Week 4 were assessed in patients with LL treatment (TIM and XARA) and in those with UL treatment (XARA).
Results:In total, 603 patients with LL treatment from both studies (58.9% male, mean [SD] age 6.8 [4.2] years, BW 23.6 [13.5] kg, 27.2% GMFCS IV-V) and 350 patients with UL treatment from XARA (62.9% male, mean [SD] age 7.3 [4.4] years, BW 25.0 [15.0] kg, 30.9% GMFCS IV-V) were included in this analysis. Improvements in AS score for the main LL and UL clinical patterns were seen with all incobotulinumtoxinA doses at Week 4 (all P
Conclusions: IncobotulinumtoxinA provides effective multipattern treatment of LL and UL spasticity in pediatric patients with CP (GMFCS I-V).
Heinen F, Kanovsky P, Schroeder AS, Chambers HG, Dabrowski E, Geister TL, et al. Pooled efficacy analysis of incobotulinumtoxinA in the multipattern treatment of upper- and lower-limb spasticity in children and adolescents with cerebral palsy. Dev Med Child Neurol. 2022 Jan;64(Suppl 1):49. doi:10.1111/dmcn.15123.