Long‐Term Observational Results from the ASPIRE Study: OnabotulinumtoxinA Treatment for Adult Lower Limb Spasticity

INTRODUCTION: OnabotulinumtoxinA treatment for spasticity varies according to numerous factors and is individualized to meet treatment goals. OBJECTIVE: To explore real‐world onabotulinumtoxinA utilization and effectiveness in patients with lower limb spasticity from the Adult Spasticity International Registry (ASPIRE) study. DESIGN: Two‐year, multicenter, prospective, observational registry (NCT01930786). SETTING: Fifty‐four international clinical sites. PATIENTS: Adults (naïve or non‐naïve to botulinum toxin[s] treatment for spasticity, across multiple etiologies) with lower limb spasticity related to upper motor neuron syndrome. INTERVENTIONS: OnabotulinumtoxinA administered at the clinician's discretion. MAIN OUTCOME MEASURES: OnabotulinumtoxinA treatment utilization, clinician‐ and patient‐reported satisfaction. RESULTS: In ASPIRE, 530 patients received ≥1 onabotulinumtoxinA treatment for lower limb spasticity (mean age, 52 years; stroke, 49.4%; multiple sclerosis, 20.4%). Equinovarus foot was treated most often (80.9% of patients), followed by flexed knee (26.0%), stiff extended knee (22.5%), and flexed toes (22.3%). OnabotulinumtoxinA doses ranged between 10 and 1100 U across all presentations. Electromyography (EMG) was most commonly used for injection localization (≥41.1% of treatment sessions). Despite low patient response on the satisfaction questionnaire, clinicians (94.6% of treatment sessions) and patients (84.5%) reported satisfaction/extreme satisfaction that treatment helped manage spasticity, and clinicians (98.3%) and patients (91.6%) would probably/definitely continue onabotulinumtoxinA treatment. These data should be interpreted with care. Twenty‐one adverse events (AEs) in 18 patients (3.4%) were considered treatment‐related. Sixty‐seven patients (12.6%) reported 138 serious AEs; 3 serious AEs in two patients (0.4%) were considered treatment‐related. No new safety signals were identified. CONCLUSIONS: ASPIRE provides long‐term observational data on the treatment of lower limb spasticity with onabotulinumtoxinA. Real‐world data from this primary analysis can help to guide the clinical use of onabotulinumtoxinA to improve spasticity management.