Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Clinician- and Patient-Reported Satisfaction: Long-Term Observational Results from the ASPIRE Study.
Journal
PM & R : the journal of injury, function, and rehabilitation
ISSN: 1934-1563
Titre abrégé: PM R
Pays: United States
ID NLM: 101491319
Informations de publication
Date de publication:
11 2020
11 2020
Historique:
received:
29
07
2019
accepted:
23
11
2019
pubmed:
19
1
2020
medline:
3
8
2021
entrez:
19
1
2020
Statut:
ppublish
Résumé
OnabotulinumtoxinA treatment for spasticity is dependent on numerous factors and varies according to selected treatment goals. To examine real-world onabotulinumtoxinA treatment utilization and effectiveness in patients with upper limb spasticity over 2 years from the Adult Spasticity International Registry (ASPIRE) study. Multicenter, prospective, observational registry (NCT01930786). Fifty-four international clinical sites in North America, Europe, and Asia. Adults (naïve or non-naïve to botulinum toxins for spasticity) with upper limb focal spasticity related to upper motor neuron syndrome across multiple etiologies. OnabotulinumtoxinA administered at clinician's discretion. OnabotulinumtoxinA utilization, clinician and patient satisfaction. Four hundred eighty-four patients received ≥1 treatment of onabotulinumtoxinA for upper limb spasticity. Patients were on average 55.1 years old, 50.8% male, predominantly Caucasian (72.3%), and 38.6% were naïve to botulinum toxins. Stroke was the most frequently reported underlying etiology (74.0%). Most patients (81.2%) had moderate to severe spasticity at baseline. The most commonly treated upper limb clinical presentation was clenched fist (79.1% of patients). Across all presentations, onabotulinumtoxinA doses ranged between 5-600U. Electromyography (EMG) was most often utilized to localize muscles (≥57.0% of treatment sessions). Clinicians (92.9% of treatment sessions) and patients (85.7%) reported being extremely satisfied/satisfied that treatment helped manage spasticity, and clinicians (98.6%) and patients (92.2%) would definitely/probably continue onabotulinumtoxinA treatment. One hundred seventy-nine patients (37.0%) reported 563 adverse events (AEs); 15 AEs in 14 patients (2.9%) were considered treatment related. Sixty-nine patients (14.3%) reported 137 serious AEs; 3 serious AEs in 2 patients (0.4%) were considered treatment related. No new safety signals were identified. ASPIRE captured the real-world individualized nature of onabotulinumtoxinA utilization for upper limb spasticity over 2 years, with consistently high clinician- and patient-reported satisfaction. Data in this primary analysis will guide clinical use of onabotulinumtoxinA, as well as provide insights to improve educational programs on spasticity management.
Identifiants
pubmed: 31953896
doi: 10.1002/pmrj.12328
pmc: PMC7687094
doi:
Substances chimiques
Neuromuscular Agents
0
Botulinum Toxins, Type A
EC 3.4.24.69
Banques de données
ClinicalTrials.gov
['NCT01930786']
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1120-1133Subventions
Organisme : NCATS NIH HHS
ID : KL2 TR003168
Pays : United States
Informations de copyright
© 2020 The Authors. PM&R published by Wiley Periodicals, Inc. on behalf of American Academy of Physical Medicine and Rehabilitation.
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