Dataset Information

Systematic literature review of abobotulinumtoxinA in clinical trials for adult upper limb spasticity.

ABSTRACT:

Objective

The aim of this study was to elucidate clinical trial efficacy, safety, and dosing practices of abobotulinumtoxinA (ABO) treatment in adult patients with upper limb spasticity (ULS).

Methods

A systematic literature review was performed to identify randomized controlled trials and other comparative clinical studies of ABO in the treatment of adult ULS published in English between January 1991 and January 2013. Medical literature databases (PubMed, Cochrane Library, and EMBASE) were searched, and a total of 295 records were identified. Of these, 12 primary publications that evaluated ABO for the management of ULS were included in the final data report.

Synthesis

Total ABO doses ranged between 500 and 1500 U for ULS. Most of the studies in ULS showed statistically significant benefits (reduction in muscle tone based on Ashworth score) of ABO vs. placebo. Statistical significance was reached for most evaluations of spasticity using the Modified Ashworth Scale. Statistically 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. Adverse events considered associated with ABO treatment included fatigue, tiredness, arm pain, skin rashes, flu-like symptoms, worsening of spasm, and weakness.

Conclusions

On the basis of data extracted from 12 randomized clinical studies, a strong evidence base (9/12 studies) exists for the use of ABO to reduce ULS caused by stroke.

SUBMITTER: Dashtipour K

PROVIDER: S-EPMC4340600 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Systematic literature review of abobotulinumtoxinA in clinical trials for adult upper limb spasticity.

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

American journal of physical medicine & rehabilitation 20150301 3

<h4>Objective</h4>The aim of this study was to elucidate clinical trial efficacy, safety, and dosing practices of abobotulinumtoxinA (ABO) treatment in adult patients with upper limb spasticity (ULS).<h4>Methods</h4>A systematic literature review was performed to identify randomized controlled trials and other comparative clinical studies of ABO in the treatment of adult ULS published in English between January 1991 and January 2013. Medical literature databases (PubMed, Cochrane Library, and EM ...[more]

PMID: 25299523

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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:AimTo assess the efficacy and safety of repeat abobotulinumtoxinA injections in reducing upper limb spasticity in children with cerebral palsy (CP).MethodThis was a double-blind, repeat-cycle study (NCT02106351) in children with CP (2-17y). Children were randomized to receive 2U/kg (control), 8U/kg, or 16U/kg abobotulinumtoxinA injections into the target muscle group (wrist or elbow flexors) and additional muscles alongside occupational therapy via a home-exercise therapy program (HETP; minimum five 15min sessions/wk). Children received 8U/kg or 16U/kg plus HETP in cycles 2 to 4.ResultsDuring cycle 1, 210 children (126 males, 84 females; mean age [SD] 9y [4y 5mo], range 2-17y; n=70/group) had at least one upper limb abobotulinumtoxinA injection and 209 complied with the HETP. At week 6 of cycle 1, children in the 8U/kg or 16U/kg groups had significantly lower Modified Ashworth scale scores versus the 2U/kg group (primary outcome: treatment differences of -0.4 [p=0.012] and -0.7 [p<0.001] respectively). All groups improved on Physician Global Assessment and children in all groups achieved their treatment goals at least as expected. Therapeutic benefits were sustained during cycles 2 to 4; muscular weakness was the only treatment-related adverse event reported in at least one child/group (4.3% and 5.7% vs 1.4% respectively).InterpretationTreatment with 8U/kg or 16U/kg abobotulinumtoxinA significantly reduced upper limb spasticity versus the 2U/kg control dose. Therapeutic benefits of abobotulinumtoxinA plus HETP were sustained with repeat treatment cycles.What this paper addsAbobotulinumtoxinA injections significantly reduced upper limb spasticity in children with cerebral palsy. Children treated with abobotulinumtoxinA and targeted home exercises showed global improvement and goal attainment. Benefits were sustained over 1 year with repeat cycles of abobotulinumtoxinA and home exercises. AbobotulinumtoxinA injections into the upper limb were well tolerated over 1 year.

Dataset Information

Systematic literature review of abobotulinumtoxinA in clinical trials for adult upper limb spasticity.

Objective

Methods

Synthesis

Conclusions

Publications

Systematic literature review of abobotulinumtoxinA in clinical trials for adult upper limb spasticity.

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