Objective:

To evaluate the 1-year interim onabotulinumtoxinA safety, effectiveness, and exploratory treatment utilization data from the ASPIRE study.

Background: OnabotulinumtoxinA treatment for patients with spasticity is individualized, variable, and dependent on numerous factors. Findings from ASPIRE will help optimize onabotulinumtoxinA treatment strategies in patients with spasticity.

Methods: This is a multicenter, prospective, observational study across 54 international sites (NCT01930786) examining adult patients with spasticity treated with onabotulinumtoxinA at the discretion of the treating physician. Follow-up assessments include utilization patterns, patient and physician satisfaction, taken at each treatment visit, 6 weeks post-treatment, and approximately 12 weeks after the final visit.

Results: At the 1-year assessment, 731 patients received ≥1 onabotulinumtoxinA treatment; 1345 and 1429 treatment sessions for upper and lower limb spasticity, respectively, and 265 patients received treatment for both upper and lower limbs. Most commonly treated upper and lower limb presentations were clenched fist (2121 treatment sessions) and equinovarus foot (2938 treatment sessions), respectively. The most frequently used localization technique was electromyography (39.5%–61.5% of treatment sessions). Across all treatments, 91.1% of physicians and 82.3% of patients reported being satisfied or extremely satisfied that treatment helped manage spasticity; 84.6% of physicians and 74.8% of patients reported that the treatment benefit was sustained, and 97.4% of physicians and 89.8% of patients would definitely or probably continue onabotulinumtoxinA treatment. A total of 211 patients (28.9%) reported 560 adverse events (AEs) of which 23 events in 17 patients (2.3%) were considered treatment-related. Serious AEs (136 events) were reported by 75 patients (10.3%); 5 serious AEs in 2 patients (0.3%) were considered treatment-related. No new safety signals were identified.

Conclusions: One-year results demonstrate the safety and effectiveness of onabotulinumtoxinA for spasticity in clinical practice. Further analyses will explore clinical and burden outcomes as well as differences across etiology and presentation.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/the-adult-spasticity-international-registry-aspire-study-1-year-results/