Efficacy and safety of abobotulinumtoxinA (Dysport®) for the treatment of hemiparesis in adults with upper limb spasticity previously treated with botulinum toxin: sub-analysis from a Phase 3, randomized controlled trial.

Lejeune, Thierry;Marciniak, Christina;McAllister, Peter;Walker, Heather;International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group;et.al.
(2017) PM&R — Vol. 9, n° 12, p. 1181-1190 (2017)

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Authors
  • Lejeune, Thierryorcid-logoUCLouvain
    Collaborator
  • Marciniak, Christina
    Author
  • McAllister, Peter
    Author
  • Walker, Heather
    Author
  • Deltombe, ThierryUCLouvain
    Author
  • International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group
    Collaborator
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Abstract
(en) OBJECTIVE: To assess the efficacy and safety of abobotulinumtoxinA in adults with upper limb spasticity previously treated with botulinum toxin A (BoNT-A). DESIGN: A post hoc analysis from a Phase 3, prospective, double-blind, randomized, placebo-controlled study (NCT01313299). SETTING: A total of 34 neurology or rehabilitation clinics in 9 countries. PARTICIPANTS: Adults aged 18-80 years with hemiparesis, ≥6 months after stroke or traumatic brain injury. This analysis focused on a subgroup of subjects with previous onabotulinumtoxinA or incobotulinumtoxinA treatment (n = 105 of 243 in the total trial population) in the affected limb. The mean age was 52 years, and 62% were male. INTERVENTION: Study subjects were randomized 1:1:1 to receive a single injection session with abobotulinumtoxinA 500 or 1000 U or with placebo in the most hypertonic muscle group among the elbow, wrist, or finger flexors (primary target muscle group [PTMG]), and ≥2 additional muscle groups from the upper limb. MAIN OUTCOME MEASUREMENTS: Efficacy and safety measures were assessed, including muscle tone (Modified Ashworth Scale [MAS] in the PTMG), Physician Global Assessment (PGA), perceived function, spasticity, active movement, and treatment-emergent adverse events. RESULTS: At week 4, more subjects had ≥1 grade improvement in MAS for the PTMG with abobotulinumtoxinA versus placebo (abobotulinumtoxinA 500 U, 81.1%; abobotulinumtoxinA 1000 U, 75.0%; placebo, 25.0%). PGA scores ≥1 were achieved by 75.7% and 87.5% of abobotulinumtoxinA 500 and 1000 U subjects versus 41.7% with placebo. Perceived function (Disability Assessment Scale), spasticity angle (Tardieu Scale), and active movement were also improved with abobotulinumtoxinA. There were no treatment-related deaths or serious adverse events. CONCLUSIONS: The efficacy and safety of abobotulinumtoxinA in subjects previously treated with BoNT-A were consistent with those in the total trial population. Hence, abobotulinumtoxinA is a treatment option in these patients, and no difference in initial dosing appears to be required compared to that in individuals not treated previously. LEVEL OF EVIDENCE: III.
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Marciniak, C., McAllister, P., Walker, H., Brashear, A., Edgley, S., Deltombe, T., Khatkova, S., Banach, M., Gul, F., Vilain, C., Picaut, P., Grandoulier, A.-S., & Gracies, J.-M. (2017). Efficacy and safety of abobotulinumtoxinA (Dysport®) for the treatment of hemiparesis in adults with upper limb spasticity previously treated with botulinum toxin: sub-analysis from a Phase 3, randomized controlled trial. PM&R, 9(12), 1181-1190. https://doi.org/10.1016/j.pmrj.2017.06.007 (Original work published 2017)