The beneficial antispasticity effect of botulinum toxin type A is maintained after repeated treatment cycles

Objective: To study the efficacy, safety, and incidence of BtxA antibody formation with repeated treatments with BtxA in post-stroke upper limb muscle spasticity. Methods: The study was a prospective open label trial. Patients with established post-stroke upper limb spasticity received 1000 units of BtxA (Dysport) into five muscles of the affected arm on study entry. Treatment was repeated every 12, 16, or 20 weeks as clinically indicated. Each patient received a total of three treatment cycles. Efficacy of treatment was assessed using the Modified Ashworth Scale. Patients were assessed on study entry and on week 4 and 12 of each treatment cycle for all safety and efficacy parameters. Blood samples for BtxA antibody assay were taken at baseline and on completion of the trial. Results: Fifty one patients were recruited and 41 of them completed the study. Improvement from the cycle one baseline was observed in all the outcome measures. Mild to moderately severe treatment related adverse events were reported in 24% of cases. There were no serious adverse events. No BtxA antibodies were detected. Conclusion: BtxA at a dose of 1000 units Dysport was efficacious in the symptomatic treatment of post-stroke upper limb spasticity. The study suggests that this effect can be maintained with repeated injections for up to at least three treatment cycles, with duration of effect per cycle of between 12 and 20 weeks. BtxA was safe in the dose used in this study and did not induce the formation of detectable levels of neutralising BtxA antibodies

Abobotulinumtoxina (Dysport®): Doses Used to Treat Upper Limb Muscles of Adults with Spasticity Participating in a Phase III Randomized, Double-Blind Placebo- Controlled Study

Introduction/Background: In a Phase III, randomized, double-blind placebo-controlled study conducted in 34 sites from 9 countries, two doses of abobotulinumtoxinA (Dysport®) 500 and 1000 units (U) were shown to be efficacious on muscle tone for the treatment of hemiparetic adults post stroke or traumatic brain injury (TBI) with a favourable safety profile.1. Materials and Methods: 243 patients received abobotulinumtoxinA 500 or 1000 U or placebo by intramuscular injection into their primary targeted muscle group (PTMG, selected from extrinsic finger flexors, wrist flexors and elbow flexors) and at least two other upper limb muscles, including shoulder muscles. Treatment was administered in a volume of 5.0 mL using electrostimulation. Doses administered to upper limb muscles are reported here. Results: For the abobotulinumtoxinA 500 U group, mean (SD) doses (U) administered in fingers flexors were: 93.5 (17.0) for flexor digitorium profundus (FDP), 95.4 (14.3) for flexor digitorium superficialis (FDS) and 76.9 (26.8) for other finger flexors (flexor pollis longus, adductor pollicis); in wrist flexors: 92.2 (18.1) for flexor carpi radialis (FCR) and 89.9 (25.7) for flexor carpi ulnaris (FCU); in elbow flexors: 88.3 (28.5) for brachioradialis, 148.5 (60.2) for brachialis and 108.6 (49.5) for other elbow muscles (biceps brachii, pronator teres) and 122.2 (44.1) in shoulder muscles (triceps brachii, pectoralis major, subscapularis, latissimus dorsi). For the abobotulinumtoxinA 1000 U group, doses administered were 195.5 (25.9) for FDP, 196.8 (28.4) for FDS, 157.0 (53.3) for other finger flexors, 178.1 (45.5) for FCR, 171.2 (45.2) for FCU, 172.1 (44.8) for brachioradialis, 321.4 (103.2) for brachialis, 216.5 (92.2) for other elbow muscles and 300.0 (129.1) in shoulder muscles. Conclusion: In this Phase III worldwide study in hemiparetic patients with upper limb spasticity post stroke/TBI, mean doses administered were 76.9–196.8 U for muscles in the finger flexors, 89.9-178.1 U for muscles in wrist flexors, 88.3–321.4 U for muscles in the elbow flexors and 122.2–300.0 U in shoulder muscles. Total dose administered (in the PTMG and at least 2 upper limb muscles) was 500 or 1000 U, which was previously shown to improve muscle tone in this patient population

Defining spasticity: a new approach considering current movement disorders terminology and botulinum toxin therapy

Spasticity is a symptom occurring in many neurological conditions including stroke, multiple sclerosis, hypoxic brain damage, traumatic brain injury, tumours and heredodegenerative diseases. It affects large numbers of patients and may cause major disability. So far, spasticity has merely been described as part of the upper motor neurone syndrome or defined in a narrowed neurophysiological sense. This consensus organised by IAB�Interdisciplinary Working Group Movement Disorders wants to provide a brief and practical new definition of spasticity�for the first time�based on its various forms of muscle hyperactivity as described in the current movement disorders terminology. We propose the following new definition system: Spasticity describes involuntary muscle hyperactivity in the presence of central paresis. The involuntary muscle hyperactivity can consist of various forms of muscle hyperactivity: spasticity sensu strictu describes involuntary muscle hyperactivity triggered by rapid passive joint movements, rigidity involuntary muscle hyperactivity triggered by slow passive joint movements, dystonia spontaneous involuntary muscle hyperactivity and spasms complex involuntary movements usually triggered by sensory or acoustic stimuli. Spasticity can be described by a documentation system grouped along clinical picture (axis 1), aetiology (axis 2), localisation (axis 3) and additional central nervous system deficits (axis 4). Our new definition allows distinction of spasticity components accessible to BT therapy and those inaccessible. The documentation sheet presented provides essential information for planning of BT therapy. © 2018, Springer-Verlag GmbH Germany, part of Springer Nature

Defining spasticity: a new approach considering current movement disorders terminology and botulinum toxin therapy

Spasticity is a symptom occurring in many neurological conditions including stroke, multiple sclerosis, hypoxic brain damage, traumatic brain injury, tumours and heredodegenerative diseases. It affects large numbers of patients and may cause major disability. So far, spasticity has merely been described as part of the upper motor neurone syndrome or defined in a narrowed neurophysiological sense. This consensus organised by IAB�Interdisciplinary Working Group Movement Disorders wants to provide a brief and practical new definition of spasticity�for the first time�based on its various forms of muscle hyperactivity as described in the current movement disorders terminology. We propose the following new definition system: Spasticity describes involuntary muscle hyperactivity in the presence of central paresis. The involuntary muscle hyperactivity can consist of various forms of muscle hyperactivity: spasticity sensu strictu describes involuntary muscle hyperactivity triggered by rapid passive joint movements, rigidity involuntary muscle hyperactivity triggered by slow passive joint movements, dystonia spontaneous involuntary muscle hyperactivity and spasms complex involuntary movements usually triggered by sensory or acoustic stimuli. Spasticity can be described by a documentation system grouped along clinical picture (axis 1), aetiology (axis 2), localisation (axis 3) and additional central nervous system deficits (axis 4). Our new definition allows distinction of spasticity components accessible to BT therapy and those inaccessible. The documentation sheet presented provides essential information for planning of BT therapy. © 2018, Springer-Verlag GmbH Germany, part of Springer Nature

Safety and efficacy of abobotulinumtoxinA for hemiparesis in adults with upper limb spasticity after stroke or traumatic brain injury: a double-blind randomised controlled trial

Resistance from antagonistic muscle groups might be a crucial factor reducing function in chronic hemiparesis. The resistance due to spastic co-contraction might be reduced by botulinum toxin injections. We assessed the effects of abobotulinumtoxinA injection in the upper limb muscles on muscle tone, spasticity, active movement, and function