Category: Spinal Cord Injury; Quality Improvement and Implementation Science
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.
Prospective, observational study (NCT01930786).
Setting : International clinical sites.
Participants (or Animals, Specimens, Cadavers) : Adult patients with focal spasticity across multiple etiologies.
Interventions : OnabotulinumtoxinA at clinician discretion.
Main Outcome Measure(s) : OnabotulinumtoxinA utilization, disability assessment scale (DAS), and patient/clinician satisfaction.
Results : 730 patients (54 years, 52% female, 77% white) received ≥1 dose of onabotulinumtoxinA. 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 (888.6U and 962.2U, respectively) than non-naive patients (1262.2U and 1197.2U). Also, 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 (cumulative mean change -1.7 for both UL and LL) following onabotulinumtoxinA. 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 continued safety and effectiveness in clinical practice.
Aaron L Ellenbogen– Neurologist, Michigan Institute for Neurological Disorders, Farmington Hills, Michigan
Wolfgang H. Jost– Professor of Neurology, University of Freiburg, Parkinson-Klinik Ortenau, Wolfach, Baden-Wurttemberg
George F. Wittenberg– Professor of Neurology and Director, VA Pittsburgh Healthcare System, University of Pittsburgh; and University of Maryland (at the time of the study), Pittsburgh, Pennsylvania
Kenneth Ngo– Associate Medical Director, Brooks Rehabilitation Hospital, Jacksonville, Florida
Joan Largent– Director, Epidemiology and Outcomes Research, IQVIA Real-World Evidence Solutions, Cambridge, Massachusetts
Aleksej Zuzek– Director, Medical Affairs, Allergan plc, Irvine, California
Gerard Francisco– Department Chairman and Chief Medical Officer, University of Texas McGovern Medical School and TIRR Memorial Hermann, Houston, Texas
Alberto Esquenazi– Department Chair and Chief Medical Officer, MossRehab Gait and Motion Analysis Laboratory, Elkins Park, Pennsylvania
Nicole Jensky– Medical Science Liaison , Allergan