Effects of incobotulinumtoxinA in children and adolescents with spastic cerebral palsy: A systematic review of randomized controlled trials.

Abstract

To evaluate the effects of incobotulinumtoxinA (incoBoNT-A) in children and adolescents with spastic cerebral palsy (CP). CP is a leading cause of childhood disability, with spasticity present in >90% of cases. BoNT-A is widely used to manage spasticity, improving function and quality of life. IncoBoNT-A, a highly purified BoNT-A formulation, offers reduced immunogenicity and greater stability across storage conditions. Although previous reviews have evaluated BoNT-A in CP, none have focused specifically on incoBoNT-A. For this systematic review, we searched databases and trial registries through February 2025 for randomized controlled trials (RCTs) comparing incoBoNT-A with placebo, other BoNT-A formulations, or different doses in patients ≤18 years with spastic CP. Meta-analyses used random- or fixed-effects models; evidence certainty was rated with Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. We included four RCTs. IncoBoNT-A showed very uncertain effects compared to onabotulinumtoxinA (onaBoNT-A) on spasticity, gait, and adverse events. Higher doses of incoBoNT-A (≥6 units/kg) showed minimal improvement in spasticity (mean difference: -0.19, 95% confidence interval [CI]: -0.36 to -0.01; moderate certainty) compared to lower doses (≤4 units/kg), with no meaningful differences in motor function, global impression of change, or adverse events. Certainty ranged from moderate to very low. The available evidence is insufficient to determine whether incoBoNT-A offers any advantages or disadvantages compared to onaBoNT-A in children with spastic CP, given the very low certainty of the data. Similarly, using a higher dose of incoBoNT-A is unlikely to yield a meaningful clinical benefit compared to a lower dose. Further high-quality trials are needed to reduce uncertainty and guide clinical decision-making.