The Effectiveness of Botulinum Toxin Type A (BoNT-A) Treatment in Brazilian Patients with Chronic Post-Stroke Spasticity: Results from the Observational, Multicenter, Prospective BCause Study.

ABSTRACT

Botulinum toxin type A (BoNT-A) is an effective treatment for post-stroke spasticity; however, some patients cannot access treatment until ≥1 year post-stroke. This Brazilian post-marketing study (NCT02390206) assessed the achievement of person-centered goals in patients with chronic post-stroke spasticity after a BoNT-A injection. Patients had a last documented stroke ≥1 year before study entry and post-stroke upper limb (UL) spasticity, with or without lower limb (LL) spasticity. Patients received BoNT-A injections at baseline (visit 1) and visit 2 (3-6 months). Primary endpoint was responder rate (achievement of primary goal from Goal Attainment Scaling (GAS)) at visit 2. Overall, 204 patients underwent GAS evaluation at visit 2, mean (SD) age was 56.4 (13.2) years and 90.7% had LL spasticity. Median (range) time between first stroke and onset of spasticity was 3.6 (0-349) months, onset of spasticity and first injection was 22.7 (0-350) months and waiting time for a rehabilitation appointment was 9.0 (1-96) months. At visit 2, 61.3% (95% CI 54.4, 67.7) of patients were responders, which was similar for UL and LL primary goals (57.8% [95% CI 49.9, 65.3] vs. 64.1% [95% CI 48.4, 77.3]). This study provides evidence to support the effectiveness of BoNT-A treatment for chronic post-stroke spasticity.