[ARTICLE] High doses of incobotulinumtoxinA for the treatment of post-stroke spasticity: are they safe and effective? – Full Text

1. Introduction

Botulinum toxin type A (BoNT-A) represents the gold standard therapy for focal spasticity and related disorders also in acquired brain injury including stroke. Since 1989, the effectiveness of BoNT-A in reducing poststroke spasticity showed reversibility and low prevalence of complications [1], obtaining the approval of U.S. Food and Drug Administration for upper limb spasticity after stroke in 2010. In the following years, many studies have been published demonstrating its safety and effectiveness [2,3]. However, the role of BoNT-A in the management of poststroke spasticity has been modified, changing from muscle chemodenervation (nerve block) to become an useful tool for improving limb posture, applying splint, consenting hygiene, standing, and walking in patients with spastic equino-varus foot deformities with also improvement joint range of motion and muscle extensibility or reduction of spasticity-related pain.

The correct evaluation of the patient to be injected is necessary to increase the efficacy of BoNT-A considering that there is a high response for improving passive function, but controversy also exists about the improvement in motor function relative to the improvement of spasticity. There are proposals on dosages, injection techniques, patient selection, and outcome measures, but a consensus about the employment of adjunctive therapies after the BoNT-A injection, considered necessary to increase the effect on spasticity reduction, has not been reached, considering the time to start, the duration of adjunctive therapies, and the type of rehabilitation procedures [4]. So, at present, the injection sites, the choice of muscles, the dosage, the dilution, and the rehabilitation programs after BoNT-A treatment are often identified by injector’s decision-making without specialized training.

BoNT-A has clearly been recommended as first-line treatment for focal spasticity by several European consensus statements and the American Academy of Neurology [4,5] and current guidelines suggested the employment of a dose up to 600 units (U) of onabotulinumtoxinA (Botox^®, Allergan, Inc., Irvine, CA, USA) and incobotulinumtoxinA (Xeomin^®, Merz Pharmaceuticals GmbH, Frankfurt, Germany) or up to 1500 U of abobotulinumtoxinA (Dysport^®, Ipsen, Slough, UK/Galderma, Paris, France) per injection session to treat spasticity after stroke [5]. However, in recent years, higher doses have been used, especially in case of upper and lower limb severe spasticity considering the low prevalence of complications and the reversibility of the BoNT-A [6,7]. The possibility to employ high doses is strictly related to the precision of the injection. A correct muscle identification with instrumental guide (i.e. electrical stimulation or ultrasonography) may reduce the spread of the toxins to the nearby tissues and the risk of adverse effects.

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[ARTICLE] Safety and efficacy of incobotulinumtoxinA as a potential treatment for poststroke spasticity – Full Text HTML/PDF

Abstract: Spasticity is a common disabling symptom for several neurological conditions. Botulinum toxin type A injection represents the gold standard treatment for focal spasticity after stroke showing efficacy, reversibility, and low prevalence of complications. In recent years, incobotulinumtoxinA, a new Botulinum toxin type A free of complexing proteins, has been used for treating several movement disorders with safety and efficacy. IncobotulinumtoxinA is currently approved for treating spasticity of the upper limb in stroke survivors, even if several studies described the use also in lower limb muscles. In the present review article, we examine the safety and effectiveness of incobotulinumtoxinA for the treatment of spasticity after stroke.

Introduction

Spasticity with muscle paresis and loss of dexterity represents one of the most common and discomforting complications affecting stroke survivors. It can have a disabling effect on stroke patients through pain and reduced mobility, affecting quality of life, and can be highly detrimental to daily functioning. Previous studies, based on the estimates of health care professionals, suggested that the prevalence of poststroke spasticity was ~60%, even if this value can be lower than the real value considering the difficulties in measuring spasticity routinely in rehabilitative settings.¹

In a recent study, conducted in a clinical setting, 39% of patients with first-ever stroke were spastic after 12 months.² Lundström et al reported that an estimated prevalence of spasticity 1 year after the first-ever stroke was 17% and that it was more prevalent in the upper limb than in the lower limb.³

In another study, spasticity was present in only 19% of the 95 subjects investigated 3 months after stroke.⁴ The same group of authors reported that 13 subjects out of 63 displayed spasticity after 18 months of stroke.⁵

There is no consensus concerning the number of patients developing spasticity. The discrepancies about the prevalence of spasticity onset after stroke might be related to various study settings and samples as well as the difficulty to measure and to identify its early development, discriminating between spastic-dystonia, muscle contracture, increase of stiffness, and other biomechanical factors. It is known that spastic hypertone can be responsible for motor impairments and activity limitations as well as for forced limb posture and pain at rest and during passive movements. The degree of spasticity may change according to the position of the patients, the task being performed, and the presence of aggravating factors such as pressure ulcers, skin infections, or urinary tract infections. Therefore, considering the variability of clinical features of stroke survivors, the assessment of spasticity is difficult as well as the need for treatment. In fact, for example, it has also been suggested that for stroke patients, the overactivity of leg extensor muscles enables them to support their body, standing position, and stance phase of gait cycle but interferes with knee flexion during the swing phase, so in this case, a botulinum toxin (BoNT) injection into rectus femoris or vastus intermedius muscles can be useful to reduce this impairment.⁶

Spasticity is also divided into generalized and focal when few muscles are involved. This type of classification can influence the choice of treatment considering not only the therapy but also the aim to improve limb posture and body image, to apply splinting, to consent hygiene, to increase passive articular range of motion, to walk and stand, to decrease pain and discomfort, to reduce the burden of care, or to prevent contracture. The purpose of this review article is to evaluate the effectiveness of the employment of incobotulinumtoxinA, a recent marked formulation of botulinum toxin type A (BoNT-A), to reduce spasticity in stroke survivors through an analysis of published clinical studies.

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[ARTICLE] Factors Influencing Goal Attainment in Patients with Post-Stroke Upper Limb Spasticity Following Treatment with Botulinum Toxin A in Real-Life Clinical Practice: Sub-Analyses from the Upper Limb International Spasticity (ULIS)-II Study – Full Text HTML

Abstract

In this post-hoc analysis of the ULIS-II study, we investigated factors influencing person-centred goal setting and achievement following botulinum toxin-A (BoNT-A) treatment in 456 adults with post-stroke upper limb spasticity (ULS). Patients with primary goals categorised as passive function had greater motor impairment (p < 0.001), contractures (soft tissue shortening [STS]) (p = 0.006) and spasticity (p = 0.02) than those setting other goal types. Patients with goals categorised as active function had less motor impairment (0.0001), contracture (p < 0.0001), spasticity (p 1 year)) post-stroke (80.0% vs. 79.2%) or presence or absence of severe contractures (76.7% vs. 80.6%), although goal types differed. Earlier BoNT-A intervention was associated with greater achievement of active function goals. Severe contractures impacted negatively on goal achievement except in pain and passive function. Goal setting by patients with ULS is influenced by impairment severity, age and time since stroke. Our findings resonate with clinical experience and may assist patients and clinicians in selecting realistic, achievable goals for treatment.

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