Abobotulinumtoxina Injections In Shoulder Muscles: Results From A Real World (Ulis-Ii) And A Phase 3 (Aul) Study

Lejeune, Thierry [UCL] et al.

OBJECTIVES: Shoulder spasticity after stroke or traumatic brain injury (TBI) may cause pain and restrict joint range of motion (ROM). Few studies have investigated botulinum toxin injections into shoulder muscles for spasticity treatment. Here we present data for sub-populations of patients receiving shoulder injections of abobotulinumtoxinA in two international, multicentre clinical studies: phase-4 ULIS-II (Upper Limb International Spasticity Study-II; post-stroke spasticity; NCT01020500) study, and phase-3 AUL open-label (Adult Upper Limb; post-stroke or -TBI spasticity; NCT01313299) study. METHODS: We present data for abobotulinumtoxinA shoulder-injected subpopulations. ULIS-II: selection and achievement of patient-centred primary goals. AUL study: Tardieu scale for passive ROM (XV1), angle of catch (XV3) and spasticity angle (X) for shoulder muscles; and Modified Frenchay Scale (MFS) for active function. RESULTS: In ULIS-II, 82 patients received abobotulinumtoxinA in shoulder muscles. Patients with shoulder injections selected the pain treatment goal twice as often as those without (Figure 1). Goal achievement for pain was 85.7%. In AUL study, 96 patients received ≥1 abobotulinumtoxinA injection in shoulder muscles, 60 of whom received ≥2 injections. Improvements in shoulder muscle spasticity were identified after first injection: mean change from baseline at Week 4 was +8.1° and +15.4° for XV1 and XV3, respectively and -7.3° for X (Figure 2). Patients with ≥2 shoulder injections showed greater improvements in XV3 and X (Figure 2). Improvements were also observed in active function (Week 4 Cycle 4: MFS: +0.62 [0.48]). CONCLUSIONS: These studies consistently showed positive outcomes for patients receiving abobotulinumtoxinA shoulder muscle injections. Patients in ULIS-II reached a high level of achievement of the most-selected patient-centred goal (pain), and in the AUL study patients had decreased shoulder spasticity on all parameters of Tardieu scale, and improved active function (MFS).