Session Information
Date: Tuesday, June 21, 2016
Session Title: Spasticity
Session Time: 12:30pm-2:00pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: To assess the safety and efficacy of escalating incobotulinumtoxinA doses (400-800U) in patients with spasticity.
Background: Botulinum toxin treatment at higher doses than currently generally used may benefit patients with severe multifocal spasticity.
Methods: This prospective dose-escalation study (NCT01603459) enrolled 155 adults (18-80 years) with spastic hemiparesis (cerebral causes) deemed to require total body doses of incobotulinumtoxinA 800U. Patients received 3 injection cycles (ICs) with escalating incobotulinumtoxinA doses (400U, 600U and 600-800U, respectively), each followed by 12-16-week observations. Outcomes included: Ashworth Scale (AS) responder rate (≥1-point improvement 4 weeks post-injection), Disability Assessment Scale (DAS), Functional Ambulatory Classification (FAC), Investigators Global Efficacy Assessment (IGEA), adverse events (AEs) and antibody testing.
Results: IncobotulinumtoxinA dose escalation enabled treatment of an increasing number of spasticity patterns in each patient. AS responses were seen in 364/608 (59.9%) patterns treated in IC1 (155 patients), 431/743 (58.0%) patterns in IC2 (152 patients) and 537/811 (66.2%) patterns in IC3 (140 patients). There was increased reporting of “no”/“slight” disability for the principal target domain (DAS score 0 or 1) after each IC (baseline: 0.7%; study end: 42.9%). The proportion of ambulator-independent patients (FAC level 5) also improved (baseline: 24.5%; study end: 40.6%). The proportion of “good”/“very good” IGEA assessments increased with escalating doses (IC1: 55.5%; IC2: 72.4%; IC3: 89.3%). Dose escalation did not increase the incidence of AEs (IC1: 36.1%; IC2: 37.5%; IC3: 25.7%) or treatment-related AEs (IC1: 4.5%; IC2: 5.3%; IC3: 2.9%). There were no treatment-related serious AEs or cases of clinical non-responsiveness due to antibodies.
Conclusions: Increasing incobotulinumtoxinA doses (400-800U) allowed the effective treatment of a rising number of spasticity patterns while maintaining safety and tolerability. Enhanced efficacy was confirmed by improved muscle tone, favourable physician global assessments, reduced upper-limb disability and greater ambulator independence.
68th American Academy of Neurology Annual Meeting 15-21 April 2016.
To cite this abstract in AMA style:
J. Wissel, D. Bensmail, B. Rubin, A. Scheschonka, O. Simon, D.M. Simpson. Safety and efficacy of escalating doses of incobotulinumtoxinA (400-800U): Increasing improvements in disability due to multifocal upper- and lower-limb spasticity [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/safety-and-efficacy-of-escalating-doses-of-incobotulinumtoxina-400-800u-increasing-improvements-in-disability-due-to-multifocal-upper-and-lower-limb-spasticity/. Accessed May 16, 2025.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-and-efficacy-of-escalating-doses-of-incobotulinumtoxina-400-800u-increasing-improvements-in-disability-due-to-multifocal-upper-and-lower-limb-spasticity/