Source:Pediatric Neurology
Author(s): Edward Dabrowski, Marcin Bonikowski, Mark Gormley, Magali Volteau, Philippe Picaut, Mauricio R. Delgado
BackgroundThe effects of botulinum toxin are transient, and repeat injections are required in children with lower-limb spasticity. However, the efficacy of botulinum toxin in patients who have received previous injections has remained largely unexplored.MethodsWe present subgroup analyses of a Phase III study conducted in ambulatory children (aged 2–17) with spastic equinus foot. Patients were randomized to single doses of abobotulinumtoxinA 10U/kg/leg, 15U/kg/leg or placebo injected into the gastrocnemius-soleus complex (one/both legs). The first analysis was pre-specified to review the effect of abobotulinumtoxinA in children previously treated with botulinum toxin versus those new to the treatment; a second post-hoc analysis evaluated the effect of abobotulinumtoxinA in children who changed botulinum toxin formulation.ResultsOf the 241 randomized patients, 113 had previously received botulinum toxin, including 86 who had been treated with another formulation. In both analyses, muscle tone (modified Ashworth Scale) and the Physicians Global Assessment at week- 4 improved with abobotulinumtoxinA treatment versus placebo, regardless of baseline botulinum toxin status. Placebo responses in patients new to treatment were consistently higher than in the previously treated group.ConclusionsThese results demonstrate similar abobotulinumtoxinA efficacy and safety profiles in children with spasticity who are new to botulinum toxin treatment and those previously treated. The efficacy and safety of abobotulinumtoxinA treatment in these previously-treated patients were comparable with the overall trial population, indicating that doses of 10U/kg/leg and 15 U/kg/leg are suitable starting doses for children with spasticity regardless of the previous botulinum toxin preparation used.
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