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.
Introduction
Upper limb spasticity (ULS) is common after stroke or traumatic brain injury (TBI). The impact can be highly significant, including abnormal hand and arm positions, impaired self-care, and limited passive/active range of motion, as well as additional burden to the caregiver [1-5].
The effectiveness of treatment with intramuscularly injected botulinum toxin A (BoNT-A) in reducing muscle tone in patients with ULS is well established [5-8]. Several guidelines now recommend BoNT-A injections as a first-line treatment option in these patients [6,7,9-11].
AbobotulinumtoxinA (Dysport; Ipsen Biopharm, Wrexham, UK) is a BoNT-A preparation approved in the United States and Europe for the treatment of ULS in adult patients [12,13]. A recent clinical trial examined the efficacy and safety of a single injection session of abobotulinumtoxinA (500 or 1000 U) in 243 adults with ULS who had hemiparesis at least 6 months after stroke or TBI [14]. The effects observed included improvements in muscle tone, perceived function, spasticity, and active range of motion. Furthermore, the treatment was well tolerated, and all treatment-related adverse events (AEs) were mild or moderate in severity.
Among the subjects enrolled in this study, 105 had previously undergone treatment in the upper limb with onabotulinumtoxinA or incobotulinumtoxinA. The aim of the present analysis was to assess the efficacy and safety of abobotulinumtoxinA in adults with ULS who had been previously treated with a BoNT-A, and to describe the doses of abobotulinumtoxinA administered to these subjects. […]
TBI Rehabilitation 