Developmental Medicine and Child Neurology
Introduction: Spasticity-related pain (SRP) in children and adolescents with cerebral palsy (CP) is common, often neglected, and impacts daily quality of life. We assessed the effect of incobotulinumtoxinA on SRP using pooled data from 3 large Phase 3 pediatric studies.
Methods: Ambulant and non-ambulant patients (2–17 years of age; uni- or bilateral CP; Ashworth Scale score ≥2 in clinical patterns for treatment) were enrolled. Patients received total body incobotulinumtoxinA doses of ≤16 U/kg (≤400 U) for lower-limb (LL) treatment 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 and upper-limb (UL) treatment. In XARA (NCT02002884), patients received 4 ICs with 16–20 U/kg (≤400–500 U) for UL or combined LL/UL treatment. Changes in self-reported (child/adolescent) or observed (parent/caregiver) SRP were assessed using the Questionnaire on Pain caused by Spasticity (QPS) in patients with LL (TIM, TIMO, and XARA) and UL treatment (TIMO and XARA).
Results:Assessments for 849 patients with LL and 454 patients with UL treatment were included. Of these, 340 (40.0%, LL: 61.2% male, mean [SD] age 9.3 [3.8], body weight [BW] 32.6 [14.8] kg) and 160 (35.2%, UL: (61.9% male, mean [SD] age 10.3 [3.7] years, BW 36.8 [16.5] kg) were able to assess SRP by interviewer- or self-administered QPS. Most (81.9% LL; 69.7% UL) reported pain at baseline for ≥1 activity. SRP increased with activity demands. Complete SRP relief at Week 4 post-treatment in each IC was seen (Table) and was highest in IC4. Observed SRP frequency was consistent with self-reported SRP and was supported by respective QPS item scores (all P
Conclusions: In this large, pooled analysis, repeated incobotulinumtoxinA injections led to sustained pain reduction in children and adolescents with spasticity, with complete pain relief in the injected limb during activities in ≤54.8% of patients.
Heinen F, Kanovsky P, Schroeder AS, Chambers HG, Dabrowski E, Geister TL, et al. Improvement of spasticity-related pain with incobotulinumtoxinA treatment in children/adolescents with cerebral palsy: pooled analysis of 3 phase 3 studies. Dev Med Child Neurol. 2022 Jan;64(Suppl 1):48. doi:10.1111/dmcn.15123.