Article

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.
CI - Copyright (c) 2017 American Academy of Physical Medicine and Rehabilitation.
Published by Elsevier Inc. All rights reserved.

Langue : ANGLAIS