IncobotulinumtoxinA for the treatment of lower-limb spasticity in children and adolescents with cerebral palsy: A phase 3 study.
Florian Heinen, Petr Kanovský, A Sebastian Schroeder and 8 others
PMID 34092664WHAT IT FOUND
Higher doses were not shown to work better than lower doses, but all incobotulinumtoxinA doses tested reduced plantar flexor tone in children with cerebral palsy lower-limb spasticity.
Key findings
01In 311 randomized and treated patients, all three dose groups (4, 12, and 16 U/kg with maximum 100, 300, and 400 U) were treated across two lower-limb clinical patterns, and all improved plantar flexor Ashworth scores at week 4, with no worsening observed.
02Investigator-rated change improved, with more than 93% of patients in each dose group rated as minimally, much, or very much improved, but no differences between dose groups were demonstrated on the primary or coprimary analyses.
03Any treatment-emergent adverse event occurred in 42.8% of patients, treatment-related adverse events in 4.8%, and no treatment-related serious or fatal adverse event was reported.
STILL TO COME
How it was doneWhat they foundWhat it means for PTs
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What it does not show
The study had no placebo group, so improvements from baseline cannot be separated from the natural course of the condition or from usual care. Patients continued usual physical therapy, orthotic management other than casting and rehabilitation, and muscle relaxants or antidepressants, so the contribution of any single component cannot be separated. The trial compared dose levels rather than testing incobotulinumtoxinA against no injection, so it does not answer whether the toxin itself caused the change. Child or adolescent reports were not available for all participants, partly because of young age or cognitive abilities. Patients with fixed contractures, predominant dystonia, recent or planned pes equinus surgery, or other excluded conditions were not studied, so the findings do not apply to those groups.
The easy way to misread this
Do not conclude that the highest dose is best. All dose groups improved tone, but the trial did not show statistically significant differences between the low, mid, and high doses on the primary or coprimary outcomes.