Posts Tagged Dysport

[ARTICLE] Dose-Dependent Effects of Abobotulinumtoxina (Dysport) on Spasticity and Active Movements in Adults With Upper Limb Spasticity: Secondary Analysis of a Phase 3 Study – Full Text

Abstract

Background

AbobotulinumtoxinA has beneficial effects on spasticity and active movements in hemiparetic adults with upper limb spasticity (ULS). However, evidence-based information on optimal dosing for clinical use is limited.

Objective

To describe joint-specific dose effects of abobotulinumtoxinA in adults with ULS.

Design

Secondary analysis of a phase 3 study (NCT01313299).

Setting

Multicenter, international, double-blind, placebo-controlled clinical trial.

Participants

A total of 243 adults with ULS >6 months after stroke or traumatic brain injury, aged 52.8 (13.5) years and 64.3% male, randomized 1:1:1 to receive a single-injection cycle of placebo or abobotulinumtoxinA 500 U or 1000 U (total dose).

Methods

The overall effect of injected doses were assessed in the primary analysis, which showed improvement of angles of catch in finger, wrist, and elbow flexors and of active range of motion against these muscle groups. This secondary analysis was performed at each of the possible doses received by finger, wrist, and elbow flexors to establish possible dose effects.

Main Outcome Measures

Angle of arrest (XV1) and angle of catch (XV3) were assessed with the Tardieu scale, and active range of motion (XA).

Results

At each muscle group level (finger, wrist, and elbow flexors) improvements in all outcome measures assessed (XV1, XV3, XA) were observed. In each muscle group, increases in abobotulinumtoxinA dose were associated with greater improvements in XV3 and XA, suggesting a dose-dependent effect.

Conclusions

Previous clinical trials have established the clinical efficacy of abobotulinumtoxinA by total dose only. The wide range of abobotulinumtoxinA doses per muscle groups used in this study allowed observation of dose-dependent improvements in spasticity and active movement. This information provides a basis for future abobotulinumtoxinA dosing recommendations for health care professionals based on treatment objectives and quantitative assessment of spasticity and active range of motion at individual joints.

Introduction

Upper limb spasticity (ULS) is a common symptom after stroke and traumatic brain injury (TBI) and is associated with impaired self-care and additional burden of care [1-5]. Among several treatment strategies, guidelines recommend intramuscular botulinum toxin injections as a first-line treatment for adults with ULS [6-11].

Botulinum toxin type A (BoNT-A) injections may target upper extremity muscle groups from the shoulder, to decrease adductor and internal rotation tone, to the elbow, wrist, fingers, and thumb, to decrease flexor tone [12,13]. Specific muscle selection is based on the pattern of muscle overactivity, functional deficits, and patient goals [6]. These goals include increased passive and active range of motion, improved function (feeding and dressing), easier care (palmar and axillary hygiene), and reduction of pain [13].

Evidence-based information on optimal dosing for clinical use is relatively sparse. Dosing is not interchangeable between different BoNT-A products; therefore, improving our understanding of product-specific dosing will minimize confusion among injectors and improve the quality of patient care [13].

Among BoNT-A formulations, abobotulinumtoxinA (Dysport; Galderma Laboratories, LP, Fort Worth, TX) has been shown to decrease muscle tone (as measured by the Modified Ashworth Scale [MAS]) [13-17] and pain [18] and to facilitate goal attainment [19] in adults with ULS. A recent systematic review [13] of 12 randomized controlled trials (RCTs) in ULS concluded that abobotulinumtoxinA (total dose range, 500-1500 U) was generally well-tolerated, with “strong evidence” to support reduced muscle tone.

This paper presents the results of a secondary analysis from a recently published large international clinical trial, demonstrating improved active range of motion after abobotulinumtoxinA treatment in adults with hemiparesis and ULS >6 months after stroke or TBI [20]. This phase 3, randomized, double-blind, placebo-controlled study demonstrated that a total dose of either 500 U or 1000 U abobotulinumtoxinA injected in the upper extremity also resulted in decreased muscle tone and improvements in global physician-assessed clinical benefit compared with placebo.

Apart from a systematic measurement of active range of motion (XA) against finger, wrist, and elbow flexors, another unique aspect of the trial was the assessment of spasticity at the finger, wrist, and elbow flexor groups with the Tardieu scale (TS) [21,22]. The TS is a standardized evaluation used to assess the angle of arrest at slow speed (ie, passive range of motion, XV1) and the angle of catch at fast speed (XV3). The trial demonstrated improvements for finger, wrist, and elbow joints at week 4 in XV3 at both abobotulinumtoxinA doses and in XA at 1000 U; for the 500-U dose, improvements in XA were seen in the finger flexors. Both doses were associated with a favorable safety profile [20]. This analysis aims to provide a detailed description of improvements in spasticity and the active range of motion for individual muscle groups by dose and to provide information on muscle-specific dosing, which can be used in future recommendations for injectors.

Continue —> Dose-Dependent Effects of Abobotulinumtoxina (Dysport) on Spasticity and Active Movements in Adults With Upper Limb Spasticity: Secondary Analysis of a Phase 3 Study – ScienceDirect

 

Figure 1. Change from baseline of Tardieu scale parameters and of active range of motion week 4 postinjection in (A) extrinsic finger flexors, (B) wrist flexors, and (C) elbow flexors. Dose groups were as follows (lowest to highest dose): 500 U/non-PTMG, 500 U/PTMG, 1000 U/non-PTMG, and 1000 U/PTMG. Standard deviations and mean change from baseline values are detailed in Table 3. PTMG = primary targeted muscle group; XV1 = passive range of motion; XV3 = angle of catch at fast speed; XA = active range of motion.

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[ARTICLE] Economic modeling of the use of botulinum toxin A in a homogenous patient population based on real-life clinical practice: ULIS-II (The Upper Limb International Spasticity Study); the French perspective

Objective

To evaluate the real life practice of the use of botulinum toxin A (BoNT-A) in post-stroke upper limb spasticity and the economic consequences of fair comparisons of the dosing between either abobotulinumtoxinA (Dysport®) or onabotulinumtoxinA (Botox®) or incobotulinumtoxinA (Xeomin®) in France.

Methods

ULIS-II is an 18-month, observational, prospective study, conducted in 84 centers in 22 countries. France was the major contributor with 14 centers. Of 456 adults with post-stroke upper limb spasticity presenting for treatment with BoNT-A, 193 patients with the same injected limb segments “upper arm and lower arm” were analyzed for the dose injected for one cycle of BoNT-A. Treatment and concomitant interventions were in accordance with routine local clinical practice. Sample size, mean (SD)/median dose (min–max) in Unit for each BoNT-A and annual cost per patient were calculated using the median dose administered and considering no vial sharing. An injection interval of 12 weeks was simulated for all BoNT-A treatments and the France listed public price was used to ascertain annual cost.

Results

For the abobotulinumtoxinA group (n = 141) a mean (SD)/median (min–max) dose of 665 U (280)/500 U (150–1500) was injected, for the onabotulinumtoxinA group (n = 37) a mean (SD)/median dose of 183 U (99)/200 U (50–500) was injected and for incobotulinumtoxinA (n = 15), a mean (SD)/median dose of 235 U (108)/200 U (100-440) was injected. Based on a BoNT-A injection interval of 12 weeks, the annual cost per patient in France would be 1123 € for abobotulinumtoxinA, 1784 € for onabotulinumtoxinA and 1784 € for incobotulinumtoxinA (based on median doses).

Conclusions

Considering the real life practice of BoNT-A injections and the comparison of treatment groups treated for the same limb segment, this analysis suggests that the use of abobotulinumtoxinA would result potentially in a reduction in the healthcare cost for the treatment of spasticity (−37%) and that more patients could be treated with abobotulinumtoxinA with a given budget.

Source: Economic modeling of the use of botulinum toxin A in a homogenous patient population based on real-life clinical practice: ULIS-II (The Upper Limb International Spasticity Study); the French perspective

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[WEB SITE] A Shot in the Arm to Treat Upper Limb Spasticity

A new type of relief from pain, stiffness, spasms, and in the upper arm that affect millions of adults affected by spasticity has just been approved by the US Food and Drug Administration (FDA). The agency’s approval of Dysport (abobotulinumtoxinA) opens the door to an injection for the treatment of upper limb spasticity (ULS) in adult patients to decrease the severity of increased muscle tone in elbow flexors, wrist flexors, and finger flexors, according to a media release from the drug’s maker Basking Ridge, NJ-based Ipsen Biopharmaceuticals.

The Ipsen Biopharmaceuticals media release outlines what the company identifies as key benefits associated with Dysport. Among those benefits, the company reports Dysport is the first therapy in the past 5 years approved by the FDA for the treatment of adults with ULS. Furthermore, the company states, the Dysport Phase III trial was the first registration study to evaluate ULS treatment in adult patients with both stroke and traumatic brain injury.

Another benefit reported by the company is statistically significant improvement in muscle tone measured by the Modified Ashworth Scale (MAS) and a significantly higher physician-rated clinical benefit measured by the Physician Global Assessment (PGA) versus placebo at Week 4 (p ≤ 0.05).

According to the media release, clinical improvement may be expected 1 week after administration of Dysport. The company also points out that a majority of patients were retreated between 12 and 16 weeks; however, some patients had duration of response as long as 20 weeks.

The most frequently reported adverse reactions (≥2%) are: urinary tract infection, nasopharyngitis, muscular weakness, musculoskeletal pain, dizziness, fall, and depression, the media release states.

All botulinum toxin products, including Dysport, are said by Ipsen Biopoharmaceuticals to have a Boxed Warning which states that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening.

[Source: Ipsen Biopharmaceuticals Inc]

via A Shot in the Arm to Treat Upper Limb Spasticity – Rehab Managment.

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