Session Time: 12:30pm-2:00pm
Location: Research Hub - Kiosk 6
Disclosures: Wolfgang H. Jost, MD: Allergan plc: Consultant/Advisory Board, Other Financial or Material Support, Speaker
Ipsen: Consultant/Advisory Board, Other Financial or Material Support, Speaker
Merz: Consultant/Advisory Board, Other Financial or Material Support, Speaker
Objective: Examine real-world onabotulinumtoxinA utilization and effectiveness over 2 years in patients naive or non-naive to botulinum toxins for treatment of spasticity from the Adult Spasticity International Registry (ASPIRE).
Design: Prospective, observational registry (NCT01930786).
Setting: International clinical sites.
Participants: Adult patients with spasticity.
Interventions: OnabotulinumtoxinA per clinician discretion.
Main Outcome Measures: OnabotulinumtoxinA utilization, disability assessment scale (DAS), and clinician/patient satisfaction.
Results: 730 patients received ≥1 dose of onabotulinumtoxinA. Patients were, on average, 54 years old, 52% female, 77% white, and the majority had moderate to severe spasticity at baseline. 37% (n=269) were naive to botulinum toxins for treatment of 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 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 (cumulative mean 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.
Conclusions: 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. They capture the individualized nature of onabotulinumtoxinA utilization for spasticity, while demonstrating its safety and effectiveness in clinical practice.
Level of Evidence: Level IV
To cite this abstract in AMA style:Jost WH, Ellenbogen AL, Wittenberg GF, Ngo K, Largent J, Zuzek A, Francisco GE, Esquenazi A. OnabotulinumtoxinA Reduces Disability in Treatment-naive Adult Patients with Spasticity: Results from the ASPIRE Study [abstract]. PM R. 2019; 11(S2)(suppl 2). https://pmrjabstracts.org/abstract/onabotulinumtoxina-reduces-disability-in-treatment-naive-adult-patients-with-spasticity-results-from-the-aspire-study/. Accessed December 9, 2023.
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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/onabotulinumtoxina-reduces-disability-in-treatment-naive-adult-patients-with-spasticity-results-from-the-aspire-study/