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,
Marcelo Riberto,
João Amaury Frances,
Regina Chueire,
Ana Cristina Ferreira Garcia Amorim,
Denise Xerez,
Tae Mo Chung,
Lucia Helena Costa Mercuri,
Alexandre Luiz Longo,
Sérgio Lianza,
Pascal Maisonobe,
Viviane C. Ruiz-Schutz
Affiliations
Patricia Khan
Centro Catarinense de Reabilitação, Florianópolis, Santa Catarina 88025-301, Brazil
Marcelo Riberto
Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, São Paulo 14049-900, Brazil
João Amaury Frances
Hospital Bettina Ferro de Souza, Campus IV da Universidade Federal do Pará, Belém, Pará 66075-110, Brazil
Regina Chueire
Faculdade de Medicina de São José do Rio Preto, Autarquia Estadual, São José do Rio Preto 15090-000, Brazil
Ana Cristina Ferreira Garcia Amorim
Centro de Reabilitação e Readaptação Dr. Henrique Santillo (CRER), Goiânia, Goiás 74653-230, Brazil
Denise Xerez
Serviço de Medicina Física e Reabilitação, Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro 21941-590, Brazil
Tae Mo Chung
Instituto de Medicina Física e Reabilitação, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo 04116-030, Brazil
Lucia Helena Costa Mercuri
Hospital São Paulo—UNIFESP, São Paulo 04024-002, Brazil
Alexandre Luiz Longo
Clinica Neurológica e Neurocirúrgica de Joinville, Joinville, Santa Catarina 89202-165, Brazil
Sérgio Lianza
Hospital Alemão Oswaldo Cruz, São Paulo 01323-020, Brazil
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.
