Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Patient and Clinician Satisfaction in the ASPIRE Study (P4.8-025)

2019 
Objective: Explore real-world onabotulinumtoxinA utilization and effectiveness in patients with upper limb spasticity over 2 years from the Adult Spasticity International Registry (ASPIRE) study. Background: OnabotulinumtoxinA treatment for spasticity is variable and dependent on numerous factors. Design/Methods: Multicenter, international, prospective, observational registry (NCT01930786), examining adult patients with spasticity across multiple etiologies treated with onabotulinumtoxinA at their clinician’s discretion. Assessments include utilization (each visit) and clinician (next visit)/patient (5±1 weeks post-treatment) satisfaction. Results: Patients (N=730) 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 were 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 clinicians and 86% of patients reported being satisfied/extremely satisfied that treatment helped manage spasticity, and 99% of clinicians and 92% of patients would definitely/probably continue treatment with onabotulinumtoxinA. 261 patients (36%) reported 831 adverse events (AEs); 23 AEs in 20 patients (3%) were considered treatment-related. 94 patients (13%) reported 195 serious AEs; 3 serious AEs in 2 patients (0.3%) were considered treatment-related. No new safety signals were identified. Conclusions: ASPIRE provides valuable, real-world data on dosing, injection guidance, and muscle targeting over 2 years, that may help guide clinical strategies. ASPIRE 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. Disclosure: Dr. Francisco has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Merz, and Ipsen. Dr. Francisco has received research support from Allergan, Merz, and Ipsen. Dr. Bavikatte has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan. Dr. Jost has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Ipsen, and Merz. Dr. Bandari has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Accorda, Biogen, Genentech, Genzyme, EMD-Serono, Mallinckrodt and Teva. Dr. Bandari has received research support from Biogen, Genentech, Allergan, Genzyme and Med-day. Dr. Tang has nothing to disclose. Dr. Munin has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merz. Dr. Munin has received research support from Allergan and Ipsen. Dr. Largent has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with IQVIA (formerly QuintilesIMS), Allergan. Dr. Zuzek has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan. Dr. Patel has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan. Dr. Esquenazi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Ipsen, and Mertz. Dr. Esquenazi has received research support from Allergan and Ipsen.
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