Developmental Medicine and Child Neurology
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).
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.