Author(s): Esquenazi A.; Jost W.; Bavikatte G.; Bandari D.; Munin M.; Zuzek A.; Patel A.; Largent J.; Francisco G.
Source: Annals of Physical and Rehabilitation Medicine; 2018
Publication Date: 2018
Publication Type(s): Article In Press
Abstract:Introduction/Background: 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 lower limb spasticity over 2 years. Material and method: 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). Results: 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 lower limb spasticity presentation was equinovarus foot (59%). Across all equinovarus foot treatment sessions (n = 1609), percentage injected and dose (mode) injected into each muscle are as follows: gastrocnemius (79%, 100 U), soleus (70%, 100 U), tibialis posterior (48%, 50 U), flexor digitorum longus (21%, 50 U), flexor hallucis longus (8%, 50 U) and other muscle (13%, 50 U). EMG was frequently used to localize the muscles to treat equinovarus foot (>40%). Across all treatment sessions, 95% of physicians and 85% of patients reported being satisfied/extremely satisfied that treatment helped manage spasticity, 89% of physicians and 76% of patients reported treatment benefit was sustained, and 98% of physicians and 92% of patients would definitely/probably continue treatment with onabotulinumtoxin A. 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. Conclusion: ASPIRE provides valuable, real-world data on dosing, injection guidance, and muscle targeting over 2 years, that may help guide clinical strategies. The study captured the individualized nature of onabotulinumtoxin A utilization for spasticity, while demonstrating consistently high satisfaction. These results add to the body of evidence on the safety and effectiveness of onabotulinumtoxin A for spasticity.
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