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Long‐Term Observational Results from the ASPIRE Study: OnabotulinumtoxinA Treatment for Adult Lower Limb Spasticity
Author(s) -
Esquenazi Alberto,
Bavikatte Ganesh,
Bandari Daniel S.,
Jost Wolfgang H.,
Munin Michael C.,
Tang Simon Fuk Tan,
Largent Joan,
Adams Aubrey Manack,
Zuzek Aleksej,
Francisco Gerard E.
Publication year - 2021
Publication title -
pmandr
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.617
H-Index - 66
eISSN - 1934-1563
pISSN - 1934-1482
DOI - 10.1002/pmrj.12517
Subject(s) - medicine , spasticity , observational study , botulinum toxin , physical therapy , adverse effect , physical medicine and rehabilitation , surgery
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.