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Quality of Life in Subjects with Upper- and Lower-Limb Spasticity Treated with IncobotulinumtoxinA

2020-03-04Journal article Open access
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dc.contributor.authorFheodoroff, K
dc.contributor.authorRekand, T
dc.contributor.authorMedeiros, L
dc.contributor.authorKoßmehl, P
dc.contributor.authorWissel, J
dc.contributor.authorBensmail, D
dc.contributor.authorScheschonka, A
dc.contributor.authorFlatau-Baqué, B
dc.contributor.authorSimon, O
dc.contributor.authorDressler, D
dc.contributor.authorSimpson, DM
dc.date.accessioned2020-10-20T15:46:00Z
dc.date.available2020-10-20T15:46:00Z
dc.date.issued2020-03-04
dc.descriptionTrial registration: ClinicalTrials.gov, NCT01603459. Date of registration: May 22, 2012.pt_PT
dc.description.abstractBackground: We evaluated quality of life among subjects with upper- and lower-limb spasticity who received escalating doses of incobotulinumtoxinA (total body doses up to 800 U) in the prospective, single-arm, dose-titration TOWER study. Methods: In this exploratory trial, subjects (N = 155; 18-80 years of age) with upper- and lower-limb spasticity due to cerebral causes who were deemed to require total body doses of up to 800 U incobotulinumtoxinA received three consecutive injection cycles of incobotulinumtoxinA (400, 600, and up to 800 U), each with 12 to 16 weeks' follow-up. QoL was assessed using the EuroQol 5-dimensions questionnaire, three-level (EQ-5D), before and 4 weeks post-injection in each injection cycle and at the end of injection cycle 3. Results: The mean EQ-5D visual analog scale scores of 155 participants continuously improved from study baseline to 4 weeks post-injection in all injection cycles (mean [standard deviation] change 6.7 [14.1], 9.6 [16.3], and 8.6 [17.0] for injection cycles 1, 2, and 3, respectively; p < 0.0001 for all, paired sample t-test). In general, among those with a change in the EQ-5D rating of their condition, the proportion of subjects with 'improvement' was greater than that with 'worsening' for individual EQ-5D dimensions across all injection cycles. At the end of injection cycle 3, the proportion of subjects rating their condition as 'normal' increased from study baseline for all dimensions, and there was a ≥ 46% reduction in the proportion of subjects with a rating of 'severe impairment'. Conclusion: These preliminary results suggest that escalating incobotulinumtoxinA doses up to 800 U are associated with improvement in quality of life ratings in subjects with multifocal upper- and lower-limb spasticity, and form a basis for future comparator studies.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationHealth Qual Life Outcomes. 2020 Mar 4;18(1):51.pt_PT
dc.identifier.doi10.1186/s12955-020-01304-4pt_PT
dc.identifier.urihttp://hdl.handle.net/10400.17/3511
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherBMCpt_PT
dc.subjectAdolescentpt_PT
dc.subjectAdultpt_PT
dc.subjectAgedpt_PT
dc.subjectBotulinum Toxins, Type Apt_PT
dc.subjectDose-Response Relationship, Drugpt_PT
dc.subjectExtremitiespt_PT
dc.subjectFemalept_PT
dc.subjectHumanspt_PT
dc.subjectInjectionspt_PT
dc.subjectMalept_PT
dc.subjectMiddle Agedpt_PT
dc.subjectMuscle Spasticitypt_PT
dc.subjectNeuromuscular Agentspt_PT
dc.subjectProspective Studiespt_PT
dc.subjectSurveys and Questionnairespt_PT
dc.subjectQuality of Lifept_PT
dc.subjectHSJ NEUpt_PT
dc.titleQuality of Life in Subjects with Upper- and Lower-Limb Spasticity Treated with IncobotulinumtoxinApt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue1pt_PT
oaire.citation.startPage51pt_PT
oaire.citation.titleHealth and Quality of Life Outcomespt_PT
oaire.citation.volume18pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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