Document Type
Conference Proceeding
Publication Date
1-2022
Publication Title
Developmental Medicine and Child Neurology
Abstract
Introduction: This analysis assessed the safety and tolerability of repeated incobotulinumtoxinA treatment for lower-limb (LL), upper-limb (UL), or combined LL/UL spasticity in ambulant and non-ambulant children/adolescents with cerebral palsy (CP) using pooled data from 3 large Phase 3 studies.
Methods: Pediatric patients with spasticity (2–17 years of age; uni- or bilateral CP; Gross Motor Function Classification System [GMFCS] level I-V; Ashworth Scale [AS] score ≥2 in clinical patterns for treatment; clinical need for treatment) were enrolled. Patients received total body incobotulinumtoxinA doses of 16 U/kg body weight (BW, ≤400 U) for LL spasticity in 2 injection cycles (ICs) in TIM (NCT01893411). In TIMO (NCT01905683), TIM completers and new recruits received 4 ICs with 16–20 U/kg (≤400–500 U) for LL or combined LL/UL treatment. In XARA (NCT02002884), patients received 4 ICs with 16–20 U/kg (≤400–500 U) for UL or combined LL/UL treatment. Adverse events (AEs) were assessed in the pooled population.
Results: In total, 907 patients (59.6% male, mean [SD] age 6.7 [4.2] years, BW 23.3 [13.9] kg) received multipattern treatment; 753 patients (83.0%) completed the studies and received up to 6 ICs. Across all ICs, 363 (40.0%) experienced an AE; 33 (3.6%) had ≥1 treatment-related AE. The most common AEs were nasopharyngitis, bronchitis, and upper-respiratory tract infection. Serious AEs (SAEs) and AEs of special interest (AESIs) were reported for 49 (5.4%) and 18 (2.0%) patients, respectively. AESIs reported in >1 patient were muscular weakness (6 patients, 0.7%), dyspnea, constipation, and dysphagia (3 patients, 0.3% each). There was no increased incidence of AEs, SAEs, or AESIs with repeated dose. No deaths were reported in these studies.
Conclusions: IncobotulinumtoxinA was safe and well tolerated for LL, UL, or combined multipattern treatment over up to 6 ICs in a comprehensive population of ambulant and non-ambulant pediatric patients with spasticity (GMFCS levels I-V).
Volume
64
Issue
Suppl 1
First Page
47
Last Page
48
Recommended Citation
Banach M, Kanovsky P, Schroeder AS, Chambers HG, Dabrowski E, Geister TL, et al. Safety of incobotulinumtoxinA in multipattern treatment of upper and lower limb spasticity in children/adolescents with cerebral palsy: pooled analysis of 3 large phase 3 studies. Dev Med Child Neurol. 2022 Jan;64(Suppl 1):47-48. doi:10.1111/dmcn.15123.
DOI
10.1111/dmcn.15123
Comments
Annual Meeting of the British Paediatric Neurology Association, January 19- 22, 2022, Virtual.