Cargando…
High clinician- and patient-reported satisfaction with individualized onabotulinumtoxinA treatment for spasticity across several etiologies from the ASPIRE study
Etiology-specific onabotulinumtoxinA utilization to manage spasticity is largely unknown. In this 1-year interim analysis, we evaluated real-world onabotulinumtoxinA utilization and effectiveness across several etiologies from the Adult Spasticity International Registry (ASPIRE) study. ASPIRE is a m...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7452133/ https://www.ncbi.nlm.nih.gov/pubmed/32875289 http://dx.doi.org/10.1016/j.toxcx.2020.100040 |
_version_ | 1783575114848141312 |
---|---|
author | Francisco, Gerard E. Bandari, Daniel S. Bavikatte, Ganesh Jost, Wolfgang H. McCusker, Emily Largent, Joan Zuzek, Aleksej Esquenazi, Alberto |
author_facet | Francisco, Gerard E. Bandari, Daniel S. Bavikatte, Ganesh Jost, Wolfgang H. McCusker, Emily Largent, Joan Zuzek, Aleksej Esquenazi, Alberto |
author_sort | Francisco, Gerard E. |
collection | PubMed |
description | Etiology-specific onabotulinumtoxinA utilization to manage spasticity is largely unknown. In this 1-year interim analysis, we evaluated real-world onabotulinumtoxinA utilization and effectiveness across several etiologies from the Adult Spasticity International Registry (ASPIRE) study. ASPIRE is a multicenter, prospective, observational registry (NCT01930786) examining stroke, multiple sclerosis [MS], cerebral palsy [CP], traumatic brain injury [TBI], and spinal cord injury [SCI] patients with spasticity treated with onabotulinumtoxinA at the clinician's discretion. Assessments included onabotulinumtoxinA utilization (each session), clinician (subsequent session)/patient (5±1 weeks post-treatment) satisfaction, and the Disability Assessment Scale (DAS; subsequent session). 730 patients received ≥1 onabotulinumtoxinA treatment, with 37% naïve to botulinum toxin(s) for spasticity. The most common etiology was stroke (n=411, 56%), followed by MS (N=119, 16%), CP (N=77, 11%), TBI (N=45, 6%), and SCI (N=42, 6%). The total body mean cumulative dose (±SD) of onabotulinumtoxinA per session ranged from 296 U (±145) in CP to 406 U (±152) in TBI. The most commonly treated upper limb presentations were clenched fist (stroke, MS, and SCI), flexed wrist (CP), and flexed elbow (TBI). Equinovarus foot was the most commonly treated lower limb presentation in all etiologies. Stroke patients showed improved DAS scores for nearly all subscales in both limbs, indicative of improved global function. All etiologies showed improved lower limb mobility DAS scores. Across all sessions, clinicians (range: 87.4% [SCI]-94.2% [CP]) and patients (range: 67.6% [TBI]-89.7% [SCI]) reported extreme satisfaction/satisfaction that onabotulinumtoxinA helped manage spasticity, and clinicians (range: 94.6% [TBI]-98.8% [CP]) and patients (range: 88.4% [stroke]-91.2% [TBI]) would definitely/probably continue treatment. Treatment-related adverse events (TRAEs) and treatment-related serious adverse events (TRSAEs) were reported as follows: stroke: 10 TRAEs (2.2% patients), 3 TRSAEs (0.5%); MS: 5 TRAEs (4.2%), 0 TRSAEs; CP: 0 TRAEs, 0 TRSAEs; TBI: 1 TRAEs (2.2%), 0 TRSAEs; SCI: 0 TRAEs, 0 TRSAEs. No new safety signals were identified. High clinician- and patient-reported satisfaction were observed following individualized onabotulinumtoxinA treatment, as well as improved global function. Interim results from ASPIRE demonstrate etiology-specific similarities and differences in clinical approaches to manage spasticity. |
format | Online Article Text |
id | pubmed-7452133 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-74521332020-08-31 High clinician- and patient-reported satisfaction with individualized onabotulinumtoxinA treatment for spasticity across several etiologies from the ASPIRE study Francisco, Gerard E. Bandari, Daniel S. Bavikatte, Ganesh Jost, Wolfgang H. McCusker, Emily Largent, Joan Zuzek, Aleksej Esquenazi, Alberto Toxicon X Article from Special Issue on Toxins 2019, Edited by:Dr. David Simpson, Dr. Marie Vidailhet, Dr. Matteo Caleo and Dr. Sabine Pellett Etiology-specific onabotulinumtoxinA utilization to manage spasticity is largely unknown. In this 1-year interim analysis, we evaluated real-world onabotulinumtoxinA utilization and effectiveness across several etiologies from the Adult Spasticity International Registry (ASPIRE) study. ASPIRE is a multicenter, prospective, observational registry (NCT01930786) examining stroke, multiple sclerosis [MS], cerebral palsy [CP], traumatic brain injury [TBI], and spinal cord injury [SCI] patients with spasticity treated with onabotulinumtoxinA at the clinician's discretion. Assessments included onabotulinumtoxinA utilization (each session), clinician (subsequent session)/patient (5±1 weeks post-treatment) satisfaction, and the Disability Assessment Scale (DAS; subsequent session). 730 patients received ≥1 onabotulinumtoxinA treatment, with 37% naïve to botulinum toxin(s) for spasticity. The most common etiology was stroke (n=411, 56%), followed by MS (N=119, 16%), CP (N=77, 11%), TBI (N=45, 6%), and SCI (N=42, 6%). The total body mean cumulative dose (±SD) of onabotulinumtoxinA per session ranged from 296 U (±145) in CP to 406 U (±152) in TBI. The most commonly treated upper limb presentations were clenched fist (stroke, MS, and SCI), flexed wrist (CP), and flexed elbow (TBI). Equinovarus foot was the most commonly treated lower limb presentation in all etiologies. Stroke patients showed improved DAS scores for nearly all subscales in both limbs, indicative of improved global function. All etiologies showed improved lower limb mobility DAS scores. Across all sessions, clinicians (range: 87.4% [SCI]-94.2% [CP]) and patients (range: 67.6% [TBI]-89.7% [SCI]) reported extreme satisfaction/satisfaction that onabotulinumtoxinA helped manage spasticity, and clinicians (range: 94.6% [TBI]-98.8% [CP]) and patients (range: 88.4% [stroke]-91.2% [TBI]) would definitely/probably continue treatment. Treatment-related adverse events (TRAEs) and treatment-related serious adverse events (TRSAEs) were reported as follows: stroke: 10 TRAEs (2.2% patients), 3 TRSAEs (0.5%); MS: 5 TRAEs (4.2%), 0 TRSAEs; CP: 0 TRAEs, 0 TRSAEs; TBI: 1 TRAEs (2.2%), 0 TRSAEs; SCI: 0 TRAEs, 0 TRSAEs. No new safety signals were identified. High clinician- and patient-reported satisfaction were observed following individualized onabotulinumtoxinA treatment, as well as improved global function. Interim results from ASPIRE demonstrate etiology-specific similarities and differences in clinical approaches to manage spasticity. Elsevier 2020-06-06 /pmc/articles/PMC7452133/ /pubmed/32875289 http://dx.doi.org/10.1016/j.toxcx.2020.100040 Text en © 2020 The Author(s) http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Article from Special Issue on Toxins 2019, Edited by:Dr. David Simpson, Dr. Marie Vidailhet, Dr. Matteo Caleo and Dr. Sabine Pellett Francisco, Gerard E. Bandari, Daniel S. Bavikatte, Ganesh Jost, Wolfgang H. McCusker, Emily Largent, Joan Zuzek, Aleksej Esquenazi, Alberto High clinician- and patient-reported satisfaction with individualized onabotulinumtoxinA treatment for spasticity across several etiologies from the ASPIRE study |
title | High clinician- and patient-reported satisfaction with individualized onabotulinumtoxinA treatment for spasticity across several etiologies from the ASPIRE study |
title_full | High clinician- and patient-reported satisfaction with individualized onabotulinumtoxinA treatment for spasticity across several etiologies from the ASPIRE study |
title_fullStr | High clinician- and patient-reported satisfaction with individualized onabotulinumtoxinA treatment for spasticity across several etiologies from the ASPIRE study |
title_full_unstemmed | High clinician- and patient-reported satisfaction with individualized onabotulinumtoxinA treatment for spasticity across several etiologies from the ASPIRE study |
title_short | High clinician- and patient-reported satisfaction with individualized onabotulinumtoxinA treatment for spasticity across several etiologies from the ASPIRE study |
title_sort | high clinician- and patient-reported satisfaction with individualized onabotulinumtoxina treatment for spasticity across several etiologies from the aspire study |
topic | Article from Special Issue on Toxins 2019, Edited by:Dr. David Simpson, Dr. Marie Vidailhet, Dr. Matteo Caleo and Dr. Sabine Pellett |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7452133/ https://www.ncbi.nlm.nih.gov/pubmed/32875289 http://dx.doi.org/10.1016/j.toxcx.2020.100040 |
work_keys_str_mv | AT franciscogerarde highclinicianandpatientreportedsatisfactionwithindividualizedonabotulinumtoxinatreatmentforspasticityacrossseveraletiologiesfromtheaspirestudy AT bandaridaniels highclinicianandpatientreportedsatisfactionwithindividualizedonabotulinumtoxinatreatmentforspasticityacrossseveraletiologiesfromtheaspirestudy AT bavikatteganesh highclinicianandpatientreportedsatisfactionwithindividualizedonabotulinumtoxinatreatmentforspasticityacrossseveraletiologiesfromtheaspirestudy AT jostwolfgangh highclinicianandpatientreportedsatisfactionwithindividualizedonabotulinumtoxinatreatmentforspasticityacrossseveraletiologiesfromtheaspirestudy AT mccuskeremily highclinicianandpatientreportedsatisfactionwithindividualizedonabotulinumtoxinatreatmentforspasticityacrossseveraletiologiesfromtheaspirestudy AT largentjoan highclinicianandpatientreportedsatisfactionwithindividualizedonabotulinumtoxinatreatmentforspasticityacrossseveraletiologiesfromtheaspirestudy AT zuzekaleksej highclinicianandpatientreportedsatisfactionwithindividualizedonabotulinumtoxinatreatmentforspasticityacrossseveraletiologiesfromtheaspirestudy AT esquenazialberto highclinicianandpatientreportedsatisfactionwithindividualizedonabotulinumtoxinatreatmentforspasticityacrossseveraletiologiesfromtheaspirestudy |