Objective: Examine real-world onabotulinumtoxinA utilization and effectiveness over 2 years in patients naive or non-naive to botulinum toxins for spasticity from the Adult Spasticity International Registry (ASPIRE) study.

Background: ASPIRE is an international, multicenter, prospective, observational registry (NCT01930786) examining adults with spasticity treated with onabotulinumtoxinA per clinician discretion.

Method: Assessments included onabotulinumtoxinA utilisation (each visit), disability assessment scale (DAS; each visit), and clinician (next visit)/patient (5±1 weeks post-treatment) satisfaction.

Results: 730 patients received ≥1 dose of onabotulinumtoxinA. Patients were, on average, 54 years old; 52% were female, 77% white, and the majority had moderate to severe spasticity at baseline. 37% (n=269) were naive to botulinum toxins for spasticity. Across all treatments, mean cumulative doses of onabotulinumtoxinA in the upper limb (UL) and lower limb (LL) were lower in treatment-naive patients (888.6U and 962.2U, respectively) than in non-naive patients (1262.2U and 1197.2U). Across all treatments, clinicians made more adjustments at the subsequent visit to onabotulinumtoxinA dose and muscles targeted in treatment-naive (46% and 42%, respectively) versus non-naive (38% and 32%) patients. Treatment-naive patients showed improvement from baseline on all DAS subscales following onabotulinumtoxinA treatment, with a mean cumulative change of -1.7 for both UL and LL. DAS scores in non-naive patients changed by -0.9 and -0.7, respectively. Overall, ≥93% of clinicians and ≥85% of patients reported being extremely satisfied/satisfied that treatment helped manage spasticity. 261 patients reported 831 adverse events (AEs); 23 AEs in 20 patients were considered treatment-related. 94 patients reported 195 serious AEs; 3 serious AEs in 2 patients were considered treatment-related. No new safety signals were identified.

Conclusion: The ASPIRE study results demonstrate that treatment paradigms for treatment-naive and non-naive patients differ regarding dosing, reassessment of muscles targeted, and disability outcomes. This study captures the individualised nature of onabotulinumtoxinA utilisation for spasticity, while demonstrating its safety and effectiveness in clinical practice.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/onabotulinumtoxina-reduces-disability-in-treatment-naive-adult-patients-with-spasticity-results-from-the-aspire-study/