XEOMIN for Adults With Upper Limb Spasticity

Significant improvement shown in studies
of upper limb spasticity (ULS) in adults

“I hope that treatment can provide more flexibility. Then maybe I could get back to doing more of the things that I did before.”

Ruben, 40, adult upper limb spasticity patient

XEOMIN® (incobotulinumtoxinA) is a prescription medicine that is injected into muscles and used to treat adults with upper limb spasticity.1

  • XEOMIN has been approved for treatment of ULS in Europe since 20092

Pivotal Trial Design

  • XEOMIN® (incobotulinumtoxinA) demonstrated significant improvement in both co-primary endpoints3
  • The study consisted of a 12-week main phase followed by three 12-week open-label extension (OLEX) treatment cycles for a total exposure duration of 48 weeks1
  • The primary clinical patterns evaluated were elbow flexors, wrist flexors, and finger flexors. Investigators may have also reported on patients’ thumb muscles as well as forearm pronators1

Significant difference was seen in the mean change on the Ashworth Scale with XEOMIN compared with placebo (P<0001)1

Demonstrated improvements in muscle tone as measured by the Ashworth Scale

Ashworth Scale is a clinical measure of resistance to passive movement1

  • Investigators evaluated 3 total primary-target clinical patterns (PTCP): flexed wrist, flexed elbow, and clenched fist1
  • Adult ULS patients showed significant improvement by week 4 with XEOMIN compared with placebo1

ashworth-scale
* The analysis is based on last observation carried forward in the intent-to-treat population.

Improvement in overall spasticity as measured by Global Impression of Change Scale (GICS)

GICS is a global measure of a patient’s functional improvement1

    The investigators’ GICS scores at week 4 demonstrated that XEOMIN was superior to placebo1

  • Investigators were asked to evaluate the patient’s global change in spasticity of the upper limb due to treatment, compared with the condition before the last injection1

gics_scale_graph

  • 3 out of 4 patients showed at least minimum improvement in spasticity with XEOMIN1
  • 43% of patients were rated as much improved (40%) or very much improved (3%) with XEOMIN, compared with only 23% in the placebo group1

ADVERSE REACTIONS

Upper Limb Spasticity: The most commonly observed adverse reactions (incidence ≥2% of patients and greater than placebo) for XEOMIN were seizure (3%), nasopharyngitis (2%), dry mouth (2%), and upper respiratory tract infection (2%).

References

  1. XEOMIN® [package insert]. Raleigh, NC: Merz North America, Inc; 2015.
  2. Data on file. Raleigh, NC: Merz North America, Inc.
  3. Elovic EP, Munin MC, Kanovsky P, Hanschmann A, Hiersemenzel R, Marciniak C. Randomized, placebo-controlled trial of incobotulinumtoxinA for upper-limb post-stroke spasticity [published online ahead of print]. Muscle Nerve. doi: 10.1002/mus.24776.