Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Clinician‐ and Patient‐Reported Satisfaction: Long‐Term Observational Results from the ASPIRE Study

INTRODUCTION: OnabotulinumtoxinA treatment for spasticity is dependent on numerous factors and varies according to selected treatment goals. 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 (naive or non-naive 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 naive 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.