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

Background: Clinical presentations of spastic hemiparesis are common and likely require treatment to multiple muscles across both the UL and LL during the same treatment session. There is interest within the clinical community to better understand how to safely and effectively treat patients with combined UL and LL spasticity with onabotulinumtoxinA.

Method: 2-year, multicenter, observational registry (NCT01930786). Adults with spasticity were treated with onabotulinumtoxinA at the clinician’s discretion. 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 N=730 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.

Conclusion: 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).

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MDS Abstracts - https://www.mdsabstracts.org/abstract/onabotulinumtoxina-treatment-in-patients-with-upper-limb-and-lower-limb-spasticity-from-the-aspire-study/