Dataset Information

Conversion to AbobotulinumtoxinA Increases Waning Time and Efficacy for Cervical Dystonia.

ABSTRACT:

Background

Symptom re-emergence before re-injection negatively impacts cervical dystonia (CD) patients receiving botulinum toxin type A (BoNT-A) therapy. Longer waning time is associated with abobotulinumtoxinA (abo-BoNT-A) as compared to onabotulinumtoxinA (ona-BoNT-A)/incobotulinumtoxinA (inco-BoNT-A) formulations.

Objectives

To compare waning time and treatment outcomes when chronically injected CD patients experiencing early waning despite being optimized on BoNT-A (ona-BoNT-A/inco-BoNT-A) were converted to abo-BoNT-A.

Methods

Thirty-three chronically injected CD participants with a waning time of ≤8 weeks were converted to abo-BoNT-A (1:2.5 dose ratio) for three injections every 12-weeks. The second and third injection patterns were kinematically optimized. Participants were converted back to their original BoNT-A for the fourth injection (1:2.5) using the same third abo-BoNT-A pattern. Participant-perceived waning times were collected post-injections. Clinical scales (Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)) and kinematic measures were collected 12-weeks post-injection and at three peak effect time-points.

Results

Compared to baseline, waning time (12-22 days) significantly increased following all abo-BoNT-A treatments (P < 0.005) but was not significantly different at the fourth injection (original BoNT-A reconversion). TWSTRS sub-scores significantly reduced following all abo-BoNT-A treatments (P < 0.0001) and at peak effect following the third injection compared to original BoNT-A. Dysphagia and muscle weakness were reported and comparable to safety of original BoNT-A formulations.

Conclusions

Optimized patients experiencing waning had significant improvement in the peak benefit as well as the duration of effect when converted to abo-BoNT-A. This effect was toxin dependent as reconversion to the original BoNT-A using the kinematically optimized pattern failed to produce an improvement in waning.

SUBMITTER: Samotus O

PROVIDER: S-EPMC10186996 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

Conversion to AbobotulinumtoxinA Increases Waning Time and Efficacy for Cervical Dystonia.

Samotus Olivia O Jog Mandar M

Movement disorders clinical practice 20230301 5

<h4>Background</h4>Symptom re-emergence before re-injection negatively impacts cervical dystonia (CD) patients receiving botulinum toxin type A (BoNT-A) therapy. Longer waning time is associated with abobotulinumtoxinA (abo-BoNT-A) as compared to onabotulinumtoxinA (ona-BoNT-A)/incobotulinumtoxinA (inco-BoNT-A) formulations.<h4>Objectives</h4>To compare waning time and treatment outcomes when chronically injected CD patients experiencing early waning despite being optimized on BoNT-A (ona-BoNT-A ...[more]

PMID: 37205243

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Project description:Background:Botulinum neurotoxins type A (BoNT-As) are commonly used treatments for cervical dystonia (CD). Clinical trials have demonstrated the benefits of them in these patients, but data from real-life clinical practice as well as comparative data on the cost and outcome of different BoNT-A formulations are limited. The aim of this study was to compare abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) on their clinical outcomes and drug costs in real-life clinical practice. Methods:This analysis included 356 adult patients with idiopathic CD treated with aboBoNT-A (n?=?253) or onaBoNT-A (n?=?103) from 38 centres across Europe and Australia (NCT00833196). The clinical outcome measures were treatment responses, changes in TWSTRS scores and changes in health utility scores from baseline to study visit 2 and 3. Health utility score was mapped from the TWSTRS total scale, using a previous publication. Costs included drug cost for France. Results:The aboBoNT-A treated group had 2.06 (95% CI: 1.15 to 3.69) times higher odds of achieving treatment response than the onaBoNT-A treated group. The adjusted mean change in TWSTRS total score from baseline to visit 3 were?-?6.42 (95% CI: -?7.52 to -?5.33) for aboBoNT-A and?-?3.94 (95% CI: -?5.68 to -?2.2) for onaBoNT-A, with a difference of -?2.48 (95% CI: -?4.57 to -?0.39). The corresponding difference in the adjusted mean change for health utility score was 0.008 (95% CI: 0.001 to 0.014). Mean treatment costs for aboBoNT-A and onaBoNT-A were 314.1 (95% CI: 299.1 to 329.0) and 346.6 (95% CI: 322.9 to 370.4) Euros, respectively. Conclusions:This comparative analysis indicated that treatment with aboBoNT-A may be less costly and lead to improved clinical outcomes when compared with onaBoNT-A, from a French healthcare system perspective. Additional comparative clinical data from larger patient cohorts, as well as more information about cost consequences of an improvement in clinical outcome would be of value to further confirm the findings.

Project description:BackgroundCervical dystonia (CD) involves painful involuntary contraction of the neck and shoulder muscles and abnormal posture in middle-aged adults. Botulinum neurotoxin type A (BoNT-A) is effective in treating CD but little is known about its associated cost-effectiveness.ObjectiveTo evaluate the cost-effectiveness of abobotulinumtoxinA for treating CD from the UK payer perspective.MethodsA Markov model was developed to evaluate the cost-effectiveness of abobotulinum-toxinA versus best supportive care (BSC) in CD, with a lifetime horizon and health states for response, nonresponse, secondary nonresponse, and BSC in patients with CD (mean age: 53 years; 37% male). Clinical improvement measured using Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was mapped to utility using data from a randomized trial of abobotulinumtoxinA. Health care resource use, costs, and other inputs were from the British National Formulary, Personal Social Services Research Unit, published literature, or expert opinion. Costs and outcomes were discounted at 3.5% per annum.ResultsIn the base case, the incremental lifetime quality-adjusted life-years (QALYs) gained from abobotulinumtoxinA arm versus BSC was 0.253 per patient, whereas the incremental cost was £7,160, leading to an incremental cost-effectiveness ratio (ICER) of £30,468 per QALY. One-way sensitivity analyses showed that these results were sensitive to the proportion of responders to abobotulinumtoxinA at first injection, duration between injections, the number of reinjections allowed among primary nonresponders, and any difference in baseline TWSTRS value between the BSC and abobotulinumtoxinA arms. Probabilistic sensitivity analysis showed that abobotulinumtoxinA was cost-effective 46% and 49% of times at thresholds of £20,000 and £30,000 per QALY, respectively. Scenarios are considered including vial-sharing, productivity losses, secondary response/nonresponse at subsequent injections, 5-year time horizon, and alternative reinjection intervals for BoNT-As produced ICERs ranging from cost-saving to £40,777 per QALY, versus BSC.ConclusionAbobotulinumtoxinA was found to be cost-effective in treating adults with CD, at acceptable willingness-to-pay thresholds in the UK.

Dataset Information

Conversion to AbobotulinumtoxinA Increases Waning Time and Efficacy for Cervical Dystonia.

Background

Objectives

Methods

Results

Conclusions

Publications

Conversion to AbobotulinumtoxinA Increases Waning Time and Efficacy for Cervical Dystonia.

Similar Datasets

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