Objective: To explore real-world patterns of onabotulinumtoxinA utilisation in patients with lower limb spasticity over 2 years.

Background: OnabotulinumtoxinA treatment for spasticity is variable as treatment is individualised and dependent on numerous factors.

Method: Multicentre, international, prospective, observational study (NCT01930786), examining adult patients with focal spasticity across multiple aetiologies treated with onabotulinumtoxinA at their physician’s discretion. Assessments included utilisation (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 aetiology (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 were as follows: gastrocnemius (79%, 100U), soleus (70%, 100U), tibialis posterior (48%, 50U), flexor digitorum longus (21%, 50U), flexor hallucis longus (8%, 50U) and other muscle (13%, 50U). EMG was frequently used to localise 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 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.

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 individualised nature of onabotulinumtoxinA utilisation for spasticity, while demonstrating consistently high satisfaction. These results add to the body of evidence on the safety and effectiveness of onabotulinumtoxinA for spasticity.

« Back to 2019 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/an-examination-of-real-world-onabotulinumtoxina-utilisation-for-the-treatment-of-lower-limb-spasticity-the-adult-spasticity-international-registry-aspire-study/