Ontology highlight
ABSTRACT:
Objective: 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.
Design: Multicenter, prospective, observational registry (NCT01930786).
Setting: Fifty-four international clinical sites in North America, Europe, and Asia.
Patients: Adults (naïve or non-naïve to botulinum toxins for spasticity) with upper limb focal spasticity related to upper motor neuron syndrome across multiple etiologies.
Interventions: OnabotulinumtoxinA administered at clinician's discretion.
Main outcome measures: OnabotulinumtoxinA utilization, clinician and patient satisfaction.
Results: 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.
Conclusions: 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.
SUBMITTER: Francisco GE
PROVIDER: S-EPMC7687094 | biostudies-literature | 2020 Nov
REPOSITORIES: biostudies-literature
PM & R : the journal of injury, function, and rehabilitation 20200227 11
<h4>Introduction</h4>OnabotulinumtoxinA treatment for spasticity is dependent on numerous factors and varies according to selected treatment goals.<h4>Objective</h4>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.<h4>Design</h4>Multicenter, prospective, observational registry (NCT01930786).<h4>Setting</h4>Fifty-four international clinical sites in N ...[more]