OnabotulinumtoxinA Treatment in Patients with Upper Limb and Lower Limb Spasticity from the ASPIRE Study

Abstract

Research Objectives Examine onabotulinumtoxinA utilization in patients with upper limb (UL) and lower limb (LL) spasticity from the Adult Spasticity International Registry (ASPIRE) study to gain real-world insights into the treatment of spastic hemiparesis. Design Prospective, observational registry (NCT01930786). Setting International clinical sites. Participants Adults with spasticity across multiple etiologies. Interventions OnabotulinumtoxinA at the clinician's discretion. Main Outcome Measures OnabotulinumtoxinA utilization and safety data were collected at each treatment session. Patients with spastic hemiparesis were defined as receiving ≥ 1 UL treatment and ≥ 1 LL treatment during the study. Results ASPIRE patients (N=730) were on average 53.6 years old, 52%; female, 77% Caucasian, 37% naive to botulinum toxin(s) for spasticity, and 56% post-stroke. Of N=730, n=284 patients were defined as hemiparetic. In hemiparetic patients treated for UL and LL at the same session (n=275), the mean total dose of onabotulinumtoxinA was 477 U for UL+LL, 257 U for UL, and 220 U for LL. Of n=275 hemiparetic patients, 56%; had a treatment interval of 10-15 weeks, 62% had 5-15 injections/session, and 82% had >5 muscles injected/session. Clenched fist was the most common UL presentation (n=219 patients), with 55% of sessions to the left side only. Equinovarus foot was the most common LL presentation (n=238 patients), with 52% of sessions to the left side only. Of the hemiparetic population (n=284), 115 patients (41%) reported 375 adverse events; 42 patients (15%) reported 80 serious adverse events. No new safety signals were identified. Conclusions This preliminary analysis from ASPIRE provides valuable, real-world evidence on the use of onabotulinumtoxinA to treat patients with combined upper limb and lower limb spasticity. OnabotulinumtoxinA was most frequently utilized to treat clenched fist (UL) and equinovarus foot (LL) in patients with spastic hemiparesis. Author(s) Disclosures Bavikatte: Consultant for Allergan(AbbVie); Francisco: Consulted/research grants from Allergan(AbbVie), Merz, and Ipsen; Esquenazi: Consulted for Allergan(AbbVie), Ipsen, and Merz. Received research grants from Allergan(AbbVie) and Ipsen; Dimyan: None reported; Ngo: None reported; Schwartz: Statistical consultant for Allergan(AbbVie); Zuzek: AbbVie employee; Jost: Speaker/consultant for Allergan(AbbVie), Ipsen, and Merz.