Efficacy and Safety of AbobotulinumtoxinA (Dysport) for the Treatment of Hemiparesis in Adults With Upper Limb Spasticity Previously Treated With Botulinum Toxin: Subanalysis From a Phase 3 Randomized Controlled Trial. Issue 12 (16th June 2017)

• Record Type: Journal Article
• Authors: Marciniak, Christina; McAllister, Peter; Walker, Heather; Brashear, Allison; Edgley, Steven; Deltombe, Thierry; Khatkova, Svetlana; Banach, Marta; Gul, Fatma; Vilain, Claire; Picaut, Philippe; Grandoulier, Anne‐Sophie; Gracies, Jean‐Michel
• Is Part Of: PM&R. Volume 9:Issue 12(2017)
• Page Start: 1181
• Page End: 1190
• Publication Date: 2017-06-16
• Subjects: Medical rehabilitation -- Periodicals; Physical therapy -- Periodicals; Physical Therapy Modalities -- Periodicals; 615.5
• DOI: 10.1016/j.pmrj.2017.06.007
• Languages: English
• ISSNs: 1934-1482

Abstract

Abstract: 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