XEOMIN® Efficacy | Pediatric Upper Limb Spasticity

Upper Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy

Consistent Clinically Meaningful Improvement in Upper Limb Spasticity1

  • Significantly greater change* from baseline in the Ashworth Scale score with the higher dose of 8 Units/kg compared with the lower dose of 2 Units/kg
  • Improvements were consistent across all clinical patterns
  • A responder analysis evaluated the proportion of patients with a 1-point change or greater on the Ashworth Scale. 86% of patients treated with XEOMIN 8 Units/kg met the responder definition, compared to 71% of patients treated with XEOMIN 2 Units/kg (nominal p value = 0.0099)
Chart showing sgreater change from baseline in the Ashworth Scale score with the higher does of 8 units per kg compared with the lower dose of 2 units per kg. Pinch to zoom

*In the absence of a placebo control, the 2 U/kg dose was used as the control and was not evaluated for efficacy. There was no significant difference in efficacy between the 2 U/kg dose and the 6 U/kg dose.

Clinically Meaningful GICS Improvement in Upper Limb Spasticity1

  • The clinical efficacy of XEOMIN was demonstrated in both ambulatory and nonambulatory patients
  • All dose groups achieved clinically meaningful improvements in Investigator GICS assessment (minimally to much improved) but were not statistically significant against the 2 U/kg dose
Chart showing that all dose groups achieved clinically meaningful improvements in Investigator GICS assessment.

*In the absence of a placebo control, the 2 U/kg dose was used as the control and was not evaluated for efficacy. There was no significant difference in efficacy between the 2 U/kg dose and the 6 U/kg dose.

GICS, Global Impression of Change Scale; ULS, Upper Limb Spasticity; U, Unit; BW, Body Weight

Consistent Meaningful Improvement from 1st to 4th Injection Cycle1

Chart displaying the AS mean change at the 4th injection.
Chart displaying the GICS at 4th injection.

Reference

  1. Data on file. Raleigh, NC: Merz North America, Inc.; 2021.