ABOBOTULINUMTOXINA INJECTIONS IN SHOULDER MUSCLES TO IMPROVE ADULT UPPER LIMB SPASTICITY: RESULTS FROM A PHASE 4 REAL-WORLD STUDY AND A PHASE 3 OPEN-LABEL TRIAL

Objective: To compare patients with upper limb spasticity who did or did not receive abobotulinumtoxinA (Dysport (R)) in shoulder muscles during 2 international clinical studies. Design: Phase 4 Upper Limb International Spasticity Study-II (ULIS-II; NCT01020500) endpoints: primary goal selection and achievement. Phase 3 Adult Upper Limb (AUL) open-label study (NCT01313299) endpoints: Disability Assessment Scale principal target of treatment and mean (standard deviation) change from baseline to week 4 (last cycle involving shoulder muscles) for pain, Modified Frenchay Scale (active function), and Tardieu Scale parameters. Patients: Shoulder population: patients receiving abobotulinumtoxinA injections in shoulder muscles (n = 82 and n = 96 in ULIS-II and AUL open-label study, respectively); non-shoulder population: patients not injected in shoulder muscles (n = 239 and n = 158, respectively). Results: ULIS-II: primary treatment goal was pain in 25.6% vs 8.4% patients (3-fold higher) in shoulder vs non-shoulder populations, with high goal-achievement for pain reduction (85.7%). AUL open-label study: Disability Assessment Scale pain selection was 9.5% vs 5.1% (almost double); pain improvements were -0.7 (0.9) vs -0.4 (0.7); active function improvements were +0.60 (0.80) vs +0.33 (0.79), in shoulder vs non-shoulder populations, respectively. Tardieu scale parameters were improved. Conclusion: High goal achievement rates for pain reduction and improved active function were observed in patients receiving abobotulinumtoxinA in shoulder muscles.