Safety and real-world dosing of onabotulinumtoxinA for the treatment of adult spasticity: post hoc analysis of the Adult Spasticity International Registry study.
Publication Title
American journal of physical medicine & rehabilitation / Association of Academic Physiatrists
Document Type
Article
Publication Date
1-3-2024
Keywords
washington; swedish; swedish neuroscience
Abstract
OBJECTIVE: To evaluate the safety of onabotulinumtoxinA treatment for spasticity across dose ranges in real-world practice.
DESIGN: Adult Spasticity International Registry (ASPIRE) was a multicenter, prospective, observational study (NCT01930786) of onabotulinumtoxinA treatment for adult spasticity over 2 years. Adverse events (AEs), serious AEs (SAEs), treatment-related AEs (TRAEs), and TRSAEs were sorted into 5 categories (=200 U, 201-400 U, 401-600 U, 601-800 U, =801 U) based on cumulative dose per session.
RESULTS: In 3103 treatment sessions (T), 730 patients received =1 dose of onabotulinumtoxinA. Dose categories included: =200 U (n = 312; t = 811), 201-400 U (n = 446, t = 1366), 401-600 U (n = 244, t = 716), 601-800 U (n = 69, t = 149), =801 U (n = 29, t = 61). Of these patients, 261 reported 827 AEs, 94 reported 195 SAEs, 20 reported 23 TRAEs, and 2 patients treated with 201-400 U onabotulinumtoxinA reported 3 TRSAEs. TRAEs reported: =200 U (8 TRAEs/811, 0.9%); 201-400 U (7/1366, 0.5%); 401-600 U (6/716, 0.8%); 601-800 U (1/149, 0.7%); =801 U (1/61, 1.6%).
CONCLUSIONS: In this post hoc analysis, most treatment sessions were performed with 201-400 U onabotulinumtoxinA. Patients treated with 201-400 U onabotulinumtoxinA had an AE profile consistent with onabotulinumtoxinA package inserts globally (eg, United States, European Union, United Kingdom, Canada). No new safety signals were identified.
Area of Special Interest
Neurosciences (Brain & Spine)
Area of Special Interest
Orthopedics & Sports Medicine
Specialty/Research Institute
Pharmacy
Specialty/Research Institute
Neurosciences
Specialty/Research Institute
Orthopedics
DOI
10.1097/PHM.0000000000002410
