Session Information
Session Title: AA 2021 Virtual Posters - Neurological Rehabilitation
Session Time: None. Available on demand.
Disclosures: Ganesh Bavikatte, MD: Allergan (Products/Services: No) (Research Grant or Support, Speaker/Honoraria includes speakers bureau, symposia, and expert witness)Ipsen (Products/Services: No) (Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received, Speaker/Honoraria includes speakers bureau, symposia, and expert witness)Merz (Products/Services: No) (Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received, Speaker/Honoraria includes speakers bureau, symposia, and expert witness)
Objective: 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: 2-year, multicenter, observational registry (NCT01930786).Setting : International clinical sites.Participants : Adults with spasticity.
Interventions: OnabotulinumtoxinA at clinician’s discretion.
Main Outcome Measures: OnabotulinumtoxinA utilization and safety data were collected at each treatment session. Patients with spastic hemiparesis included those that received ≥1 UL treatment and ≥1 LL treatment during the 2-year study.
Results: Of Nf730 patients in ASPIRE, n=284 patients were defined as hemiparetic, with n=275 patients treated for the UL and LL at the same treatment session (n=275 described hereafter). Hemiparetic patients were on average 53.2 years old, 51.3% male, 68.0% Caucasian, 39.3% naïve to botulinum toxin for spasticity, and 72.7% post-stroke. The mean total dose of onabotulinumtoxinA was 477 U for UL+LL, 257 U for UL, and 220 U for LL. Of the 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. 94 patients (34.2%) reported 293 non-serious adverse events (AEs); 9 AEs in 9 patients (3.3%) were considered treatment-related. 42 patients (15.3%) reported 80 serious AEs; 3 serious AEs in 2 patients (0.7%) were considered treatment-related. No new safety signals were identified.Conclusions: This ASPIRE analysis provides valuable, real-world evidence on the use of onabotulinumtoxinA to treat patients with spastic hemiparesis, with onabotulinumtoxinA most frequently utilized to treat clenched fist (UL) and equinovarus foot (LL).
Level of Evidence: Level II
To cite this abstract in AMA style:
Bavikatte G, Dimyan MA, Zuzek A, Schwartz M, Jost WH, Ngo K, Esquenazi A, Francisco GE. OnabotulinumtoxinA Treatment in Patients with Upper Limb and Lower Limb Spasticity from the ASPIRE Study [abstract]. PM R. 2021; 13(S1)(suppl 1). https://pmrjabstracts.org/abstract/onabotulinumtoxina-treatment-in-patients-with-upper-limb-and-lower-limb-spasticity-from-the-aspire-study/. Accessed October 8, 2024.« Back to AAPM&R Annual Assembly 2021
PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/onabotulinumtoxina-treatment-in-patients-with-upper-limb-and-lower-limb-spasticity-from-the-aspire-study/