AbobotulinumtoxinA injections in shoulder muscles: Results from a real world (ULIS-II) and a phase 3 (AUL) study

Abstract

Shoulder spasticity post-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 (aboBoNT-A) in two international, multicentre clinical studies: phase-4 Upper Limb International Spasticity Study-II (ULIS-II; post-stroke spasticity; NCT01020500 ), and phase-3 AUL open-label study (Adult Upper Limb; post-stroke or -TBI spasticity; NCT01313299 ). ULIS-II: selection and achievement of patient-centred primary goals. AUL study: Tardieu scale for passive ROM (X V1 ), angle of catch (X V3 ) and spasticity angle (X) for shoulder muscles; and Modified Frenchay Scale (MFS) for active function. In ULIS-II, 82 patients receiving aboBoNT-A in shoulder muscles selected pain treatment goal three times more often than those without ( Fig. 1 ), with high goal achievement (85.7 and 85.0%, respectively). In AUL study, 96 patients received ≥1 injection cycle in shoulder muscles, of which 84 received ≥ 2 shoulder injections. In patients with 1 shoulder injection, improved shoulder muscle spasticity (Tardieu) at last injection cycle: mean change from baseline at Week 4 was +12.3° and −8.2° for X V3 , and X, respectively ( Fig. 2 ). Patients with ≥ 2 shoulder injections had an improvements of +17.9° in X V3 . Concomitant improvements were also observed in active function (Week 4 Cycle 4, ≥ 2 shoulder injections: MFS: +0.71 [0.48]) ( Fig. 3 ). A trend towards lower injection doses in proximal compared with distal muscles was seen. Post-stroke or -TBI patients receiving abobotulinumtoxinA in shoulders, in addition to other proximal muscle groups, reached high levels of goal achievement, particularly relating to pain and showed improvement in active function (MFS).