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Systematic Literature Review of AbobotulinumtoxinA in Clinical Trials for Lower Limb Spasticity.

ABSTRACT: To elucidate clinical trial efficacy, safety, and dosing practices of AbobotulinumtoxinA (ABO) treatment in adult patients with lower limb spasticity.A systematic literature review was performed to identify randomized controlled trials of ABO in the treatment of adult lower limb spasticity.Of the 295 records identified, 6 primary publications evaluated ABO for the management of lower limb spasticity of various etiologies and were evaluated. Total ABO doses ranged between 500 and 2000 U for lower limb spasticity, depending on the muscles injected. All studies in lower limb spasticity showed statistically significant reduction in muscle tone based on Modified Ashworth Scale of ABO versus placebo. Significant effects on active movement and pain were demonstrated albeit less consistently. ABO was generally well tolerated across the individual studies; most adverse events reported were considered unrelated to treatment. Treatment-related adverse events included but not limited to fatigue, local pain at injection site, hypertonia, dry mouth, weakness of the noninjected muscle, abnormal gait, and urinary tract infection.These data from 6 randomized clinical studies provide the beginnings of an evidence base for the use of ABO to reduce lower limb spasticity. Ongoing studies in this area will add to this evidence base.

SUBMITTER: Dashtipour K

PROVIDER: S-EPMC4718273 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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Systematic Literature Review of AbobotulinumtoxinA in Clinical Trials for Lower Limb Spasticity.

Dashtipour Khashayar K Chen Jack J JJ Walker Heather W HW Lee Michael Y MY

Medicine 20160101 2

To elucidate clinical trial efficacy, safety, and dosing practices of AbobotulinumtoxinA (ABO) treatment in adult patients with lower limb spasticity.A systematic literature review was performed to identify randomized controlled trials of ABO in the treatment of adult lower limb spasticity.Of the 295 records identified, 6 primary publications evaluated ABO for the management of lower limb spasticity of various etiologies and were evaluated. Total ABO doses ranged between 500 and 2000 U for lower ...[more]

PMID: 26765447

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Project description:BackgroundBotulinum neurotoxins type A (BoNT-As) are used in pediatric lower limb spasticity, which affects more than 2.5 million children worldwide. Botulinum neurotoxins type-A improve active function and delay musculoskeletal complications. The objective of this analysis was to evaluate the efficacy and safety of abobotulinumtoxinA versus other botulinum neurotoxins type A in pediatric spasticity, in the absence of head-to-head evidence.MethodsA systematic literature review was conducted to identify relevant randomized controlled trials. The evidence base was synthesized with Bayesian network meta-analyses. Outcomes analyzed included Modified Ashworth Scale, Tardieu Scale (TS) spasticity grade, and Goal Attainment Scale (standard mean difference only) at 12 weeks postinjection, and adverse events occurring during study periods.ResultsThirty-eight studies were identified, 10 of which met inclusion criteria for quantitative synthesis. On Modified Ashworth Scale, abobotulinumtoxinA 15 U/kg/leg was significantly more efficacious than onabotulinumtoxinA 4 U/kg/leg (-0.99 [-1.34, -0.64]) and onabotulinumtoxinA 4 U/kg/leg+casting (-0.81 [-1.16, -0.46]) and numerically better than onabotulinumtoxinA 8 U/kg (-0.40 [-0.67, -0.14]). AbobotulinumtoxinA 10 U/kg/leg was significantly more efficacious than onabotulinumtoxinA 4 U/kg/leg (±casting). On Goal Attainment Scale, abobotulinumtoxinA 15 U/kg/leg and 10 U/kg/leg were significantly more efficacious than onabotulinumtoxinA 12 U/kg/leg. On Tardieu Scale spasticity grade, abobotulinumtoxinA was comparable to other treatments. AbobotulinumtoxinA demonstrated adverse event rates comparable to all doses of onabotulinumtoxinA.ConclusionsIn pediatric lower limb spasticity, abobotulinumtoxinA offered significant or numerical efficacy advantages on tone (Modified Ashworth Scale) and functional outcomes (Goal Attainment Scale), and comparable efficacy on Tardieu Scale spasticity grade. AbobotulinumtoxinA was comparable to onabotulinumtoxinA on tolerability. Results should be interpreted in the context of heterogeneity and sparsity of the evidence base.

Project description:Introduction: Spasticity is the main complication of many upper motor neuron disorders. Many studies describe neuro-orthopedic surgeries for the correction of joint and limb deformities due to spasticity, though less in the upper extremity. The bulk of care provided to patients with spasticity is provided by rehabilitation clinicians, however, few of the surgical outcomes have been summarized or appraised in the rehabilitation literature. Objective: To review the literature for neuro-orthopedic surgical techniques in the upper limb and evaluate the level of evidence for their efficacy in adult patients with spasticity. Method: Electronic databases of MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews were searched for English, French as well as Farsi languages human studies from 1980 to July 2, 2020. After removing duplicated articles, 2,855 studies were screened and 80 were found to be included based on the criteria. The studies were then divided into two groups, with 40 in each trial and non-trial. The results of the 40 trial articles were summarized in three groups: shoulder, elbow and forearm, and wrist and finger, and each group was subdivided based on the types of intervention. Results: The level of evidence was evaluated by Sackett's approach. There were no randomized control trial studies found. About, 4 studies for shoulder, 8 studies for elbow and forearm, 26 studies for wrist and finger (including 4 for the thumb in palm deformity), and 2 systematic reviews were found. Around, two out of 40 trial articles were published in the rehabilitation journals, one systematic review in Cochrane, and the remaining 38 were published in the surgical journals. Conclusion: Most surgical procedures are complex, consisting of several techniques based on the problems and goals of the patient. This complexity interferes with the evaluation of every single procedure. Heterogenicity of the participants and the absence of clinical trial studies are other factors of not having a single conclusion. This review reveals that almost all the studies suggested good results after the surgery in carefully selected cases with goals of reducing spasticity and improvement in function, pain, hygiene, and appearance. A more unified approach and criteria are needed to facilitate a collaborative, evidence-based, patient referral, and surgical selection pathway.

Project description:Background: Recent studies of botulinum toxin for post-stroke spasticity indicate potential benefits of early treatment (i. e., first 6 months) in terms of developing hypertonicity, pain and passive function limitations. This non-interventional, longitudinal study aimed to assess the impact of disease duration on the effectiveness of abobotulinumtoxinA treatment for upper limb spasticity. Methods: The early-BIRD study (NCT01840475) was conducted between February 2013 and 2018 in 43 centers across Germany, France, Austria, Netherlands and Switzerland. Adult patients with post-stroke upper limb spasticity undergoing routine abobotulinumtoxinA treatment were followed for up to four treatment cycles. Patients were categorized by time from stroke event to first botulinum toxin-A treatment in the study (as defined by the 1st and 3rd quartiles time distribution) into early-, medium- and late- start groups. We hypothesized that the early-start group would show a larger benefit (decrease) as assessed by the modified Ashworth scale (MAS, primary endpoint) on elbow plus wrist flexors compared with the late-start group. Results: Of the 303 patients enrolled, 292 (96.4%) received ≥1 treatment and 186 (61.4%) received 4 injection cycles and completed the study. Patients in all groups showed a reduction in MAS scores from baseline over the consecutive injection visits (i.e., at end of each cycle). Although reductions in MAS scores descriptively favored the early treatment group, the difference compared to the late group did not reach statistical significance at the last study visit (ANCOVA: difference in adjusted means of 0.15, p = 0.546). Conclusions: In this observational, routine-practice study, patients in all groups displayed a benefit from abobotulinumtoxinA treatment, supporting the effectiveness of treatment for patients at various disease stages. Although the data revealed some trends in favor of early vs. late treatment, we did not find strong evidence for a significant benefit of early vs. late start of treatment in terms of reduction in MAS scores.

Project description:ObjectivesSpasticity is an incurable chronic condition, and patients with spasticity frequently experience symptoms such as muscle stiffness, restricted mobility, fatigue, spasms, and pain. The study objective was to assess the cost-effectiveness of abobotulinumtoxinA plus best supportive care compared with best supportive care alone for the early treatment of adult lower limb spasticity following an acute event (e.g. stroke or traumatic brain injury), from an Australian payer perspective.MethodsUsing clinical data from published pivotal trials, an economic model based on a Markov model was developed to capture changes in treatment costs, healthcare resource use costs, functional outcomes, and health-related quality of life over a lifetime horizon. Scenario analyses and a probabilistic sensitivity analysis were conducted to explore the uncertainty in the model parameters and assumptions used in the base case.ResultsAbobotulinumtoxinA plus best supportive care was cost-effective versus best supportive care, yielding an incremental cost-effectiveness ratio of $35,721 per quality-adjusted life year gained. Sensitivity analyses confirm the robustness of the base case, with most results remaining below the commonly acceptable cost-effectiveness willingness-to-pay threshold of $75,000 per quality-adjusted life year for cost-effectiveness in Australia. Inputs and assumptions that produced the top four highest incremental cost-effectiveness ratios include the application of different health resource utilisation source, short time horizon, unweighted regression analyses to determine regression probabilities, and no stopping rule. AbobotulinumtoxinA plus best supportive care has a 74% probability of being cost-effective compared with best supportive care alone at the willingness to pay threshold.ConclusionAbobotulinumtoxinA plus best supportive care treatment is cost-effective in Australia for the management of adult lower limb spasticity in patients treated within 2 years of an acute event.

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Systematic Literature Review of AbobotulinumtoxinA in Clinical Trials for Lower Limb Spasticity.

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Systematic Literature Review of AbobotulinumtoxinA in Clinical Trials for Lower Limb Spasticity.

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