Author(s): Bavikatte G.; Francisco G.E.; Bandari D.S.; Jost W.H.; Zuzek A.; Largent J.; Esquenazi A.
Source: International Journal of Stroke; Oct 2018; vol. 13 (no. 2); p. 17
Publication Date: Oct 2018
Publication Type(s): Conference Abstract
Abstract:Background: OnabotulinumtoxinA treatment for spasticity is individualized, variable, and dependent on numerous factors. This analysis examines onabotulinumtoxinA utilization and effectiveness for the treatment of spasticity in post-stroke patients. Method(s): An international, multicenter, prospective, observational registry (NCT01930786) examining adults with spasticity treated with onabotulinumtoxinA at the physician’s discretion. Assessments include onabotulinumtoxinA utilization (each visit) and physician (next visit)/patient (5+/-1 weeks posttreatment) satisfaction. Result(s): Patients (N=731) were on average 54 years old, majority female (52%) and continuing botulinum toxin treatment for spasticity (63%). The majority of patients (n=411; 56%) had spasticity resulting from stroke. Among stroke patients, the most common upper limb presentation was clenched fist (72%), with onabotulinumtoxinA doses ranging from 10-500U; flexor digitorum superficialis (86%) was the most commonly injected muscle. The most common lower limb presentation was equinovarus foot (56%), with onabotulinumtoxinA doses ranging from 15-630U; gastrocnemius (77%) was the most commonly injected muscle. Overall (N=731), the majority of patients (85%) and physicians (95%) reported extreme satisfaction/satisfaction that onabotulinumtoxinA treatment helped their spasticity. Patients (92%) and physicians (99%) reported they would definitely/probably continue onabotulinumtoxinA treatment for spasticity. Overall (N=731), 261 patients (36%) reported 831 adverse events (AEs), with 23 AEs in 20 patients (3%) considered treatment-related. 94 patients (13%) reported 195 serious AEs, with 3 serious AEs in 2 patients (0.3%) considered treatment-related. No new safety signals were identified. Conclusion(s): Real-world data from ASPIRE captured onabotulinumtoxinA treatment patterns in post-stroke patients treated for spasticity in clinical practice, while further demonstrating the effectiveness and safety of onabotulinumtoxinA for spasticity.