There is greater benefit than risk in using abobotulinumtoxinA at doses up to 30 U/kg for pediatric patients presenting with lower limb spasticity, according to results of a phase 3, prospective, multicenter, open-label study published in the Journal of Child Neurology.
Investigators evaluated outcomes among ambulatory children (2-17 years of age) who received 4 cycles of abobotulinumtoxinA injection at doses of 5 to 30 U/kg at 12-week intervals (n=216). Patients had cerebral palsy that resulted in a dynamic equinus foot deformity.
Among 207 patients who ultimately underwent 1 injection cycle of abobotulinumtoxinA, a total of 175 patients had a second injection, 86 were given 3 injections, and 11 subjects had 4 injections.
Treatment-emergent adverse events, such as nasopharyngitis, upper respiratory tract infections, and pyrexia, were reported in 150 (73.5%) patients. Only 1 mild-intensity treatment-emergent adverse event was reported for each of these patients, and all of these events were considered unrelated to treatment. The investigators observed significant improvements in muscle tone, spasticity, goal attainment, and overall clinical benefit across all injection cycles.
According to the researchers, the exclusion of patients with severe cerebral palsy (Gross Motor Function Classification System levels IV–V) may limit the overall generalizability of these findings across the entire pediatric patient population. Additionally, the small number of patients entering the fourth injection cycle may have provided findings that were not significant.
Considering “there has been a distinct lack of studies evaluating the long-term efficacy of repeat [abobotulinumtoxinA] treatment in this group of patients,” this study provides greater insight into the clinical utility and safety outcomes of using this therapy in ambulatory pediatric patients with cerebral palsy.
Delgado MR, Bonikowski M, Carranza J, et al. Safety and efficacy of repeat open-label abobotulinumtoxinA treatment in pediatric cerebral palsy. J Child Neurol. 2017;32(13):1058-1064.