Safety and real-world dosing of onabotulinumtoxinA for the treatment of adult spasticity: post hoc analysis of the Adult Spasticity International Registry study.

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.