Abstract
Introduction:Botulinum toxin type A (BoNT-A) is used in the management of lower limb spasticity in children, which affects more than 2.5 million children worldwide. BoNT-A aims to improve active function and to prevent or delay future musculoskeletal complications. The objective was to evaluate the relative efficacy and safety of different BoNT-A to manage spasticity in children, in the absence of head-to-head evidence.Methods:A systematic literature review was conducted in March 2016 to identify all relevant randomized controlled trials. The evidence base was synthesized by means of Bayesian network meta-analyses. Scenario analyses included standardized mean differences (SMD). The endpoints were Modified Ashworth Scale (MAS), Tardieu scale-spasticity grade and Goal Attainment Scale (GAS) (SMD only) at twelve weeks post-injection, and any adverse events.Results:Thirty-eight studies were identified, ten of which met the inclusion criteria for quantitative synthesis. For MAS, abobotulinumtoxinA 15 U/kg/leg was significantly better compared to onabotulinumtoxinA 4 U/kg/leg (−0.99 [−1.49; –0.50]), onabotulinumtoxinA 4 U/kg/leg + casting (−0.81 [−1.30; –0.32]) and numerically (although not statistically significantly) better than onabotulinumtoxinA 8 U/kg (−0.70 [−1.64; 0.22], Pbetter=93%). For GAS, abobotulinumtoxinA 15 U/kg/leg was numerically better than onabotulinumtoxinA 12 U/kg/leg. On Tardieu scale-spasticity grade, abobotulinumtoxinA was comparable to other treatments. AbobotulinumtoxinA 15 U/kg/leg showed the highest SUCRA value on MAS and GAS. On tolerability, abobotulinumtoxinA was found to have comparable or fewer adverse events than onabotulinumtoxinA 4 U/kg/leg.Conclusions:Our analyses suggest that abobotulinumtoxinA offers a comparable or favourable efficacy on tone (measured by MAS), spasticity (Tardieu scale-spasticity grade), functional outcomes (GAS) and tolerability versus onabotulinumtoxinA, in the management of children with lower limb spasticity. The results must be interpreted in the context of the heterogeneity of the evidence base and sparse evidence base.
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More From: International Journal of Technology Assessment in Health Care
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