Jörg Wissel, Djamel Bensmail, Astrid Scheschonka, Birgit Flatau-Baqué, Olivier Simon, Michael Althaus, David M. Simpson
Department of Neurorehabilitation and Physical Therapy, Department of Neurology, Vivantes Hospital Spandau, Neue Bergstraße, , Berlin, Germany. E-mail: joerg@schwarz-wissel.de, joerg.wissel@vivantes.de
DOI: 10.2340/16501977-2651

Objective: The Titration study in lOWer and uppER-limb spasticity (TOWER) study (NCT01603459), evaluated incobotulinumtoxinA for upper- and lower-limb spasticity. This post hoc analysis assessed shoulder spasticity in patients who received injections into the shoulder.
Methods: Subjects received 3 injection cycles with escalating incobotulinumtoxinA doses on the same side (400, 600, 600–800 U; ≤ 600 U per limb including optional shoulder dose, planned range 100–250 U). Joint function was assessed with the Ashworth Scale shoulder sumscore (AS-SSS) in subjects treated in the shoulder vs those who were not. Safety was assessed in subjects treated in the shoulder, and in those who had upper-limb treatment without shoulder treatment.
Results: The proportion of subjects receiving shoulder treatment increased with escalating dose at each cycle (n = 84/140 (60. 0%) by cycle 3; mean (standard deviation (SD)) shoulder dose 118. 4 U (SD 60. 2)). From baseline to 4-weeks post-injection, mean AS-SSS improved by –1. 1 (SD 1. 9), –1. 7 (SD 1. 8) and –1. 7 (1. 8) in cycles 1, 2 and 3, respectively, in subjects treated in the shoulder, and –0. 5 (SD 1. 3), –0. 8 (SD 1. 6) and –0. 9 (SD 1. 4) in subjects who were not. A significant dose effect on AS-SSS was observed in cycle 3 (p = 0. 0081). No unexpected safety concerns were reported.
Conclusion: The results demonstrate an improvement in shoulder spasticity and safety following incobotulinumtoxinA treatment.

After a stroke, many patients experience disabling spasticity of the limbs, characterized by stiffness and an inability to control the muscles. Spasticity in the shoulder muscles can lead to a limited range of motion and severe pain. The TOWER study looked at the use of incobotulinumtoxinA for upper- and lower-limb spasticity. The subsequent analysis of data from the TOWER study determined the effect of incobotulinumtoxinA for the treatment of spasticity in the shoulder muscles. The results showed that muscle tone in the shoulder muscles improved from baseline after treatment with incobotulinumtoxinA. No unexpected safety concerns were reported. Thus, incobotulinumtoxinA has potential as a treatment for patients who experience shoulder spasticity after a stroke.