AbobotulinumtoxinA for the Tx of Hemiparesis in Adults With Upper Limb Spasticity



Title: 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

Marciniak, C. et al.


 

What You Need to Know:

According to results of a post-hoc analysis, abobotulinumtoxinA (Dysport) has shown to be an effective treatment option for patients with upper limb spasticity who were treated previously with botulinum toxin A (BoNT-A).

Trial Design:

  • Post-hoc analysis of a multicenter, prospective, double-blind, placebo-controlled phase 3 trial evaluated the safety and efficacy of abobotulinumtoxinA in patients with “upper limb spasticity treated previously with BoNT-A
  • Patient population included 18-80 year old adults who experienced hemiparesis for at least 6 months following a stroke or traumatic brain injury
  • 243 patients were randomized (1:1:1) to receive one injection of abobotulinumtoxinA 500 U, abobotulinumtoxinA 1000 U, or placebo into “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”
  • Endpoints assessed: “muscle tone (Modified Ashworth Scale [MAS] in the PTMG), Physician Global Assessment (PGA), perceived function, spasticity, active movement, and treatment-emergent adverse events”

Key Outcomes:

  • At week 4, 81.1% of abobotulinumtoxinA 500 U patient and 75.0% of abobotulinumtoxinA 1000 U patients achieved an improvement of at least 1 grade in MAS for the PTMG vs 25.0% of placebo patients
  • 75.7% of abobotulinumtoxinA 500 U patients and 87.5% of abobotulinumtoxinA 1000 U patients achieved PGA scores ≥1 vs 41.7% of placebo patients
  • Improvement was also seen in assessments of perceived function, spasticity angle, and active movement in patients treated with abobotulinumtoxinA
  • No serious adverse events or treatment-related deaths were reported