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.

Keywords: pain; quality of life; spasticity; stroke.

Figure 1

Study design and patient disposition. ^† One patient who completed the study and attended visit 3 was not included in the FAS population. FAS, full analysis set; GAS, goal attainment scaling.

Figure 2

Mean GAS T score during cycles 1 and 2 according to injected limb (FAS). Error bars represent SD. Means are based on the number of non-missing observations in the FAS at the concerned time points. GAS, Goal Attainment Scale; FAS, full analysis set; n, number of patients; SD, standard deviation.

Figure 3

Functional independence according to the FAC classification at visits 1, 2 and 3 (FAS). Error bars represent 95% CI. Percentages are based on the number of non-missing observations in the FAS, data for 24 patients were missing for visits 1 and 2, and data for 47 patients were missing for visit 3. Level 0, non-functional; level 1, dependent level II; level 2, dependent level I; level 3, dependent on supervision; level 4, independent on level ground; level 5, independent. CI, confidence interval; FAC, Functional Ambulation Category; FAS, full analysis set.

Figure 4

Factors that made receiving treatment difficult for patients (FAS) ^† Lack of family support includes having no relative to accompany the patient to appointments. The denominator of percentage is the number of subjects in the FAS. Data for 98 (48.0%) patients in the FAS were missing; the sum of percentages may exceed 100%. FAS, full analysis set.