An examination of real-world onabotulinumtoxinA utilization for the treatment of upper limb spasticity: The Adult Spasticity International Registry (ASPIRE) study

Abstract

OnabotulinumtoxinA treatment for spasticity is variable as treatment is individualized and dependent on numerous factors. Here, we explore real-world patterns of onabotulinumtoxinA utilization in patients with upper limb spasticity over 2 years. Multicenter, international, prospective, observational study ( NCT01930786 ), examining adult patients with focal spasticity across multiple etiologies treated with onabotulinumtoxinA at their physician's discretion. Assessments include utilization (each treatment visit) and patient/physician satisfaction (5 ± 1 weeks post-treatment). Patients ( n = 731) were on average 53.6 years of age (18.5–93.2 years), 52% female, and predominantly Caucasian (77%). Stroke was the most frequently reported etiology (56%). The most commonly treated upper limb spasticity presentation was clenched fist (52%). Across all clenched fist treatment sessions ( n = 1505), percentage injected and dose (mode) injected into each muscle are as follows: flexor digitorum superficialis (86%, 50U), flexor digitorum profundus (80%, 50U), flexor pollicis longus (25%, 20U), flexor pollicis brevis (9%, 25U), other (6%, 20U). EMG was frequently used to localize muscles to treat clenched fist (> 44%). Across all treatment sessions, 93% of physicians and 86% of patients reported being satisfied/extremely satisfied that treatment helped manage spasticity, 84% of physicians and 76% of patients reported treatment benefit was sustained, and 99% of physicians and 92% of patients would definitely/probably continue treatment with onabotulinumtoxinA. Two hundred and sixty-one patients (36%) reported 831 adverse events (AEs); 23 AEs in 20 patients (3%) were considered treatment-related. Ninety-four patients (13%) reported 195 serious AEs; 3 serious AEs in 2 patients (0.3%) were considered treatment-related. No new safety signals were identified. ASPIRE provides valuable, real-world data on dosing, injection guidance, and muscle targeting over 2 years, that may help guide clinical strategies. This study captured the individualized nature of onabotulinumtoxinA utilization for spasticity, while demonstrating consistently high satisfaction. These results add to the body of evidence on the safety and effectiveness of onabotulinumtoxinA for spasticity.