Assessing the burden of illness from cervical dystonia using the Toronto Western Spasmodic Torticollis Rating Scale scores and health utility: a meta-analysis of baseline patient-level clinical trial data

Jen, Min‐Hua; Kurth, H.; Iheanacho, Ike; Dinet, Jérôme; Gabriel, Sylvie; Wasiak, Radoslaw; Jost, Wolfgang H.

doi:10.3111/13696998.2014.953680

Cited by 6 publications

(3 citation statements)

References 21 publications

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“…Of note, the relatively unrestrictive entry criteria to the observational studies allowed us to include subjects with a broader spectrum of disease than most RCTs. This is highlighted by lower mean TWSTRS Total scores (33.95 in the present analysis vs. 43.23 in RCTs) [ 25 ], supporting the idea that RCTs often recruit subjects with more severe disease [ 25 ]. Moreover, we also observed that most patients presented with a complex pattern of dystonic movements and the majority had additional components of shoulder elevation, tremor and/or jerk.…”

Section: Discussionsupporting

confidence: 70%

Spectrum of practice in the routine management of cervical dystonia with abobotulinumtoxinA: findings from three prospective open-label observational studies

Misra

Trosch²,

Maisonobe

et al. 2018

J Clin Mov Disord

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BackgroundCervical dystonia is a heterogeneous disorder with several possible presentations, for which first-line therapy is often botulinum toxin (BoNT). In routine clinical practice the success of each BoNT injection is dependent on several variables, including individual presentation and injection technique. Large multicenter, observational studies provide important information on individualized administration strategies that cannot be otherwise ascertained from controlled clinical trials. In this meta-analysis of patient level data, we aimed to evaluate the clinical characteristics of patients with cervical dystonia undergoing routine treatment with botulinum toxin, specifically abobotulinumtoxinA. We also aimed to characterize current abobotulinumtoxinA injection techniques and parameters and to explore international differences in patient presentation and treatment.MethodsThis was a meta-analysis of baseline data from three prospective, international, multicenter, observational studies (NCT01314365, NCT00833196 and NCT01753349) of botulinum toxin treatment for the routine management of adult cervical dystonia.ResultsData presented illustrate the significant heterogeneity of CD presentation in routine practice. Most subjects presented with a complex pattern of dystonic movements and the majority had additional components of shoulder elevation, tremor and/or jerk. Dosing was generally in accordance with that recommended in the abobotulinumtoxinA prescribing information, although the range of dosing also indicates that injections are tailored to individual presentation. Sub-group analyses at the country level revealed distinct differences in injection practice.ConclusionsThis meta-analysis is based on the largest dataset of subjects with cervical dystonia studied to date. The heterogeneity revealed in our baseline findings support the need to develop consistent, practical and comprehensive best practice guidelines.

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Section: Discussionsupporting

confidence: 70%

Spectrum of practice in the routine management of cervical dystonia with abobotulinumtoxinA: findings from three prospective open-label observational studies

Misra

Trosch²,

Maisonobe

et al. 2018

J Clin Mov Disord

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“…The EQ-5D was not directly administered to patients. Instead, it was calculated from a simple mapping algorithm described in a previously published paper (see Jen et al 2014), which estimated the linear association between the TWSTRS total score and EQ-5D health utilities [17]. CD patients in the Jen study were administered both the TWSTRS, and the Short Form-36 (SF-36) Health Survey.…”

Section: Discussionmentioning

confidence: 99%

Economic evaluation of AbobotulinumtoxinA vs OnabotulinumtoxinA in real-life clinical management of cervical dystonia

et al. 2020

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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.

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“…Higher doses of BT and more local injections are needed for complex forms of CD. Initial dose of 500 IU of Dysport ® can be increased if needed 16 . In our patients initial dose of 500 IU was sufficient to provide good therapeutic response.…”

Section: Tablementioning

confidence: 99%

The effect of physical therapy in the treatment of patients with cervical dystonia with or without concomitant use of botulinum toxin

Stanković

Čolović

Živković

et al. 2018

VSP

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Background/Aim. Botulinum toxin is a basic, recommended method of treatment in controlling cervical dystonia (CD). Physical therapy has limited effect due to the nature of the disease that is a result of a disorder in structures and relationships of the basal ganglia. The aim of this study was to analyze the effect of physical therapy applied as monotherapy, or with parallel application of botulinum toxin in patients with CD. Methods. Randomized controlled clinical pilot study included 14 patients diagnosed with idiopathic CD. All patients were initially assessed by using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and Torticollis Rating Scale (Tsui scale). In the control group, composed of 5 patients, the treatment included only physical therapy. The experimental group (9 patients) was first given botulinum toxin, and physical therapy was applied after five days. Physical therapy was conducted five times a week in the period of two weeks at the Clinic. Patients of both groups were instructed to continue with the physical therapy at home. The effects of treatment

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Assessing the burden of illness from cervical dystonia using the Toronto Western Spasmodic Torticollis Rating Scale scores and health utility: a meta-analysis of baseline patient-level clinical trial data

Abstract: This study was able to define TWSTRS scores in patients with CD in terms of associated utility. This approach could help in capturing the disease's burden through measures that are more tangible than TWSTRS scores to patients, carers, clinicians, and healthcare payers.

Cited by 6 publications

References 21 publications

Spectrum of practice in the routine management of cervical dystonia with abobotulinumtoxinA: findings from three prospective open-label observational studies

Spectrum of practice in the routine management of cervical dystonia with abobotulinumtoxinA: findings from three prospective open-label observational studies

Economic evaluation of AbobotulinumtoxinA vs OnabotulinumtoxinA in real-life clinical management of cervical dystonia

The effect of physical therapy in the treatment of patients with cervical dystonia with or without concomitant use of botulinum toxin

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