Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2020 Dec 4;12(12):770.
doi: 10.3390/toxins12120770.

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

Patricia Khan  1 , Marcelo Riberto  2 , João Amaury Frances  3 , Regina Chueire  4 , Ana Cristina Ferreira Garcia Amorim  5 , Denise Xerez  6 , Tae Mo Chung  7 , Lucia Helena Costa Mercuri  8 , Alexandre Luiz Longo  9 , Sérgio Lianza  10 , Pascal Maisonobe  11 , Viviane C Ruiz-Schutz  12
Affiliations
Observational Study

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

Patricia Khan et al. Toxins (Basel). .

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.

PubMed Disclaimer

Conflict of interest statement

P.K.: received consultancy fees from Ipsen and Allergan, and honorarium as a speaker from Ipsen and Allergan. M.R.: supported by Ipsen, Allergan and Merz in scientific events as a speaker or participant. J.A.F.: sponsored by Ipsen and Allergan. R.C.: sponsored by Ipsen and Merz in scientific events as a speaker or participant. A.C.F.G.A.: sponsored by Ipsen, Allergan, Merz to attend scientific meetings, and has received funds as an instructor for Dysport. D.X.: received fees from Ipsen and Allergan. T.M.C.: no conflicting interests. L.H.C.M.: supported Ipsen, Allergan and Merz as a speaker for presentations and workshops about botulinum toxin and chemical blockade; sponsored by Ipsen and Merz to attend scientific meetings. A.L.L.: no conflicting interests. S.L.: no conflicting interests. P.M.: employee of Ipsen. V.C.R.-S.: employee of Ipsen at the time this research was carried out.

Figures

Figure 1
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
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
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
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.
See this image and copyright information in PMC

References

    1. Sommerfeld D.K., Eek E.U., Svensson A.K., Holmqvist L.W., von Arbin M.H. Spasticity after stroke: Its occurrence and association with motor impairments and activity limitations. Stroke. 2004;35:134–139. doi: 10.1161/01.STR.0000105386.05173.5E. - DOI - PubMed
    1. Watkins C.L., Leathley M.J., Gregson J.M., Moore A.P., Smith T.L., Sharma A.K. Prevalence of spasticity post stroke. Clin. Rehabil. 2002;16:515–522. doi: 10.1191/0269215502cr512oa. - DOI - PubMed
    1. Lundstrom E., Terent A., Borg J. Prevalence of disabling spasticity 1 year after first-ever stroke. Eur. J. Neurol. 2008;15:533–539. doi: 10.1111/j.1468-1331.2008.02114.x. - DOI - PubMed
    1. Simpson D.M., Hallett M., Ashman E.J., Comella C.L., Green M.W., Gronseth G.S., Armstrong M.J., Gloss D., Potrebic S., Jankovic J., et al. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016;86:1818–1826. doi: 10.1212/WNL.0000000000002560. - DOI - PMC - PubMed
    1. Sheean G., Lannin N.A., Turner-Stokes L., Rawicki B., Snow B.J., Cerebral Palsy I. Botulinum toxin assessment, intervention and after-care for upper limb hypertonicity in adults: International consensus statement. Eur. J. Neurol. 2010;17:74–93. doi: 10.1111/j.1468-1331.2010.03129.x. - DOI - PubMed

Publication types

Substances

Grants and funding