Botulinum Toxin Type A Improves Function According to Goal Attainment in Adults with Poststroke Lower Limb Spasticity in Real Life Practice.

INTRODUCTION: Botulinum toxin type A (BoNT-A) is an effective and well-tolerated treatment for adult lower limb spasticity. However, data are inadequate to determine BoNT-A efficacy for active function. This study evaluated functional goal achievement (measured by goal attainment scaling [GAS]) following lower limb BoNT-A injection in clinical practice. METHODS: Phase 4, postmarketing, multicenter, prospective, observational study (NCT01444794) in adults with poststroke lower limb spasticity receiving one BoNT-A injection cycle. Assessments were at baseline (pretreatment), 1 month ±7 days (visit 1), and 3-5 months posttreatment (visit 2). Primary outcome measure was GAS; additional assessments included Modified Ashworth Scale, Demeurisse Motricity Index, 10-meter walk test, and Disability Assessment Scale. RESULTS: Of 100 enrolled patients, 94 completed the study. Most common primary treatment goals at baseline were improving mobility (57.5%) and positioning (18.1%). At visit 2, 88.3% achieved their primary goal; 87.0% (n = 47/54) for mobility, and 100.0% (n = 17/17) for positioning. In total, 79.1% of patients achieved their secondary goals. Two factors were predictive of primary goal achievement: time since stroke onset (OR 0.907; 95% CI 0.827-0.995; p = 0.038); and absence of stiff knee spasticity pattern (OR 0.228; 95% CI 0.057-0.911; p = 0.036). All functional scales showed improvements; walking speed (mean [SD]) improved by 0.06 (0.13) and 0.05 (0.20) m/s at visits 1 and 2, respectively. CONCLUSIONS: BoNT-A injection for lower limb spasticity led to high goal achievement rates in patient-centered GAS evaluation and functional and symptomatic improvements. BoNT-A may therefore deliver clinically meaningful functional improvements in real-life practice.

Tratamiento farmacológico temprano de la espasticidad postictus con toxina botulínica tipo A: recomendaciones de consenso basadas en la evidencia / Early pharmacologic treatment with botulinum toxin A in post-stroke spasticity: consensus evidence-based recommendations

Resumen. La espasticidad es una secuela común en los pacientes que han sufrido un ictus. La identificación de pacientes con alto riesgo de presentar espasticidad postictus e iniciar el tratamiento en fases tempranas probablemente beneficiaría al paciente. Se revisaron las áreas clave en el manejo temprano de la espasticidad postictus, y se consideraron las implicaciones clínicas y la solidez de las evidencias. El documento elaborado por los coordinadores fue sometido a revisión y se elaboró un texto, que finalmente se validó. El grupo de expertos recomienda definir el tratamiento temprano de la espasticidad como el que comienza antes de los tres primeros meses tras el ictus. El panel considera muy importante identificar los factores de riesgo asociados con la aparición de la espasticidad, ya que esto podría reducir su impacto. Se definen las situaciones más frecuentes subsidiarias de tratamiento precoz tanto del miembro superior como del miembro inferior. El panel recomienda que el tratamiento con toxina botulínica tipo A sea administrado por especialistas que posean una amplia experiencia en el diagnóstico y manejo clínico de la espasticidad. En conclusión, el tratamiento de la espasticidad focal en los primeros tres meses tras un ictus está indicado en determinadas situaciones. Estas recomendaciones ayudan a estandarizar el manejo temprano de la espasticidad postictus, con la consiguiente ayuda para el clínico y los pacientes (AU)

Summary. Spasticity is a common complication that occurs in those patients that have suffered a stroke. To identify those patients at high risk of having post-stroke spasticity and to start treatment at early stages would probably benefit the patient. The key aspects in the early management of post-stroke spasticity were review and the clinical implications and strength of evidences were also considered. The document drafted by the study coordinators was subsequently reviewed and then a validated document was developed. The experts recommend defining early treatment of spasticity as one that begins before the first three months after stroke. The panel considers very important to identify the risk factors associated with the onset of spasticity, since this might reduce its impact. Additionally, the most common conditions subsidiaries of early treatment of both upper and lower limb are defined. The panel recommends that the treatment with botulinum toxin A must only be given by specialists with experience in diagnosis and management of spasticity. In conclusion, the treatment of focal spasticity in the first three months after stroke is indicated in certain situations. These recommendations help to standardize the early management of post-stroke spasticity, with the consequent support to clinicians and patients (AU)