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

OBJECTIVE

To evaluate the effects of incobotulinumtoxinA (incoBoNT-A) in children and adolescents with spastic cerebral palsy (CP).

LITERATURE SURVEY: 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.

METHODOLOGY: 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.

SYNTHESIS: 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.

CONCLUSIONS

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.