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Duration of Symptom Relief Between Injections for AbobotulinumtoxinA (Dysport®) in Spastic Paresis and Cervical Dystonia: Comparison of Evidence From Clinical Studies

Background: Botulinum toxin-A is a well-established treatment for adult and pediatric spastic paresis and cervical dystonia. While guidelines and approved labels indicate that treatment should not occur more frequently than every 12 weeks, studies and real-world evidence show that the timing of symp...

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Autores principales: Esquenazi, Alberto, Delgado, Mauricio R., Hauser, Robert A., Picaut, Philippe, Foster, Keith, Lysandropoulos, Andreas, Gracies, Jean-Michel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7546809/
https://www.ncbi.nlm.nih.gov/pubmed/33101184
http://dx.doi.org/10.3389/fneur.2020.576117
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author Esquenazi, Alberto
Delgado, Mauricio R.
Hauser, Robert A.
Picaut, Philippe
Foster, Keith
Lysandropoulos, Andreas
Gracies, Jean-Michel
author_facet Esquenazi, Alberto
Delgado, Mauricio R.
Hauser, Robert A.
Picaut, Philippe
Foster, Keith
Lysandropoulos, Andreas
Gracies, Jean-Michel
author_sort Esquenazi, Alberto
collection PubMed
description Background: Botulinum toxin-A is a well-established treatment for adult and pediatric spastic paresis and cervical dystonia. While guidelines and approved labels indicate that treatment should not occur more frequently than every 12 weeks, studies and real-world evidence show that the timing of symptom recurrence between treatments may vary. Methods: We report retreatment criteria and response duration (retreatment intervals) from four pivotal, double-blind, placebo-controlled studies with open-label extensions involving patients treated with abobotulinumtoxinA (aboBoNTA) for upper limb (NCT01313299) or lower limb (NCT01249404) spastic paresis in adults, lower limb spastic paresis in children (NCT01249417), and cervical dystonia in adults (NCT00257660). We review results in light of recently available preclinical data. Results: In spastic paresis, 24.0–36.9% of upper limb patients treated with aboBoNTA and 20.1–32.0% of lower limb patients did not require retreatment before 16 weeks. Moreover, 72.8–93.8% of aboBoNTA-treated pediatric patients with lower limb spastic paresis did not require retreatment before 16 weeks (17.7–54.0% did not require retreatment before 28 weeks). In aboBoNTA-treated patients with cervical dystonia, 72.6–81.5% did not require retreatment before 16 weeks. Conclusion: AboBoNTA, when dosed as recommended, offers symptom relief beyond 12 weeks to many patients with spastic paresis and cervical dystonia. From recently available preclinical research, the amount of active neurotoxin administered with aboBoNTA might be a factor in explaining this long duration of response.
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spelling pubmed-75468092020-10-22 Duration of Symptom Relief Between Injections for AbobotulinumtoxinA (Dysport®) in Spastic Paresis and Cervical Dystonia: Comparison of Evidence From Clinical Studies Esquenazi, Alberto Delgado, Mauricio R. Hauser, Robert A. Picaut, Philippe Foster, Keith Lysandropoulos, Andreas Gracies, Jean-Michel Front Neurol Neurology Background: Botulinum toxin-A is a well-established treatment for adult and pediatric spastic paresis and cervical dystonia. While guidelines and approved labels indicate that treatment should not occur more frequently than every 12 weeks, studies and real-world evidence show that the timing of symptom recurrence between treatments may vary. Methods: We report retreatment criteria and response duration (retreatment intervals) from four pivotal, double-blind, placebo-controlled studies with open-label extensions involving patients treated with abobotulinumtoxinA (aboBoNTA) for upper limb (NCT01313299) or lower limb (NCT01249404) spastic paresis in adults, lower limb spastic paresis in children (NCT01249417), and cervical dystonia in adults (NCT00257660). We review results in light of recently available preclinical data. Results: In spastic paresis, 24.0–36.9% of upper limb patients treated with aboBoNTA and 20.1–32.0% of lower limb patients did not require retreatment before 16 weeks. Moreover, 72.8–93.8% of aboBoNTA-treated pediatric patients with lower limb spastic paresis did not require retreatment before 16 weeks (17.7–54.0% did not require retreatment before 28 weeks). In aboBoNTA-treated patients with cervical dystonia, 72.6–81.5% did not require retreatment before 16 weeks. Conclusion: AboBoNTA, when dosed as recommended, offers symptom relief beyond 12 weeks to many patients with spastic paresis and cervical dystonia. From recently available preclinical research, the amount of active neurotoxin administered with aboBoNTA might be a factor in explaining this long duration of response. Frontiers Media S.A. 2020-09-25 /pmc/articles/PMC7546809/ /pubmed/33101184 http://dx.doi.org/10.3389/fneur.2020.576117 Text en Copyright © 2020 Esquenazi, Delgado, Hauser, Picaut, Foster, Lysandropoulos and Gracies. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Neurology
Esquenazi, Alberto
Delgado, Mauricio R.
Hauser, Robert A.
Picaut, Philippe
Foster, Keith
Lysandropoulos, Andreas
Gracies, Jean-Michel
Duration of Symptom Relief Between Injections for AbobotulinumtoxinA (Dysport®) in Spastic Paresis and Cervical Dystonia: Comparison of Evidence From Clinical Studies
title Duration of Symptom Relief Between Injections for AbobotulinumtoxinA (Dysport®) in Spastic Paresis and Cervical Dystonia: Comparison of Evidence From Clinical Studies
title_full Duration of Symptom Relief Between Injections for AbobotulinumtoxinA (Dysport®) in Spastic Paresis and Cervical Dystonia: Comparison of Evidence From Clinical Studies
title_fullStr Duration of Symptom Relief Between Injections for AbobotulinumtoxinA (Dysport®) in Spastic Paresis and Cervical Dystonia: Comparison of Evidence From Clinical Studies
title_full_unstemmed Duration of Symptom Relief Between Injections for AbobotulinumtoxinA (Dysport®) in Spastic Paresis and Cervical Dystonia: Comparison of Evidence From Clinical Studies
title_short Duration of Symptom Relief Between Injections for AbobotulinumtoxinA (Dysport®) in Spastic Paresis and Cervical Dystonia: Comparison of Evidence From Clinical Studies
title_sort duration of symptom relief between injections for abobotulinumtoxina (dysport®) in spastic paresis and cervical dystonia: comparison of evidence from clinical studies
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7546809/
https://www.ncbi.nlm.nih.gov/pubmed/33101184
http://dx.doi.org/10.3389/fneur.2020.576117
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