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.
Highlights
Post-stroke spasticity has been reported to occur in 17–38% of stroke cases [1,2,3]
Botulinum toxin type A (BoNT-A) products are approved for the treatment of upper limb (UL) and lower limb (LL) spasticity in adults in a number of countries worldwide; in Brazil, the first marketing authorization was granted for onabotulinumtoxinA in 2000 [12]
Recent studies have demonstrated that treatment with BoNT-A as early as 2–12 weeks following stroke may prevent the development of spasticity and improve muscle tone, improving prognosis [13,14,15,16]
Summary
Post-stroke spasticity has been reported to occur in 17–38% of stroke cases [1,2,3]. Botulinum toxin type A (BoNT-A) injections are a known effective treatment for spasticity and are often recommended in clinical practice [4,5,6]. Lower limb (LL) spasticity reduces muscle tone and spasticity symptoms, and improves range of motion (ROM) and functions such as walking speed [7,8,9,10,11] These physical improvements may enhance the patient’s quality of life (QoL) and reduce the perceived burden on caregivers. Standard practice and treatment guidelines recommend that rehabilitation programs start early in the management of post-stroke spasticity [6], in many low- and middle-income countries this approach is not possible. The BCause study (Botulinum toxin in the treatment of Chronic post-stroke spAStic patiEnts; NCT02390206) evaluated the achievement of individual person-centered goals, using Goal Attainment. The study aimed to document the time between the onset of spasticity and access to treatment, the sociodemographic profile of the patients, and the standard of care, to identify potential barriers responsible for the delay in receiving adequate treatment
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