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AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions

INTRODUCTION: Cervical dystonia (CD) is a neurologic movement disorder with potentially disabling effects and significant impact on quality of life of those affected. AbobotulinumtoxinA (aboBoNT-A) was initially approved for a dilution of 500 U/1 mL and subsequently for a dilution of 500 U/2 mL, pro...

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Autores principales: Lew, Mark F., Hauser, Robert A., Isaacson, Stuart H., Truong, Daniel, Patel, Atul T., Brashear, Allison, Ondo, William, Maisonobe, Pascal, Dashtipour, Khashayar, Bahroo, Laxman, Wietek, Stefan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8636802/
https://www.ncbi.nlm.nih.gov/pubmed/34888518
http://dx.doi.org/10.1016/j.prdoa.2021.100115
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author Lew, Mark F.
Hauser, Robert A.
Isaacson, Stuart H.
Truong, Daniel
Patel, Atul T.
Brashear, Allison
Ondo, William
Maisonobe, Pascal
Dashtipour, Khashayar
Bahroo, Laxman
Wietek, Stefan
author_facet Lew, Mark F.
Hauser, Robert A.
Isaacson, Stuart H.
Truong, Daniel
Patel, Atul T.
Brashear, Allison
Ondo, William
Maisonobe, Pascal
Dashtipour, Khashayar
Bahroo, Laxman
Wietek, Stefan
author_sort Lew, Mark F.
collection PubMed
description INTRODUCTION: Cervical dystonia (CD) is a neurologic movement disorder with potentially disabling effects and significant impact on quality of life of those affected. AbobotulinumtoxinA (aboBoNT-A) was initially approved for a dilution of 500 U/1 mL and subsequently for a dilution of 500 U/2 mL, providing flexibility for clinicians to treat CD. Here, we explore the safety and efficacy of the 500 U/2 mL dilution versus 500 U/1 mL dilution of aboBoNT-A in a retrospective analysis based on published clinical trial data. METHODS: The safety and efficacy of aboBoNT-A in patients with CD was evaluated in three multicenter, double-blind, randomized, placebo-controlled trials and open-label extensions. Trials 1 (NCT00257660) and 2 (NCT00288509) evaluated the 500 U/1 mL dilution in 80 and 116 patients, respectively; Trial 3 (NCT01753310) evaluated the 500 U/2 mL dilution in 125 patients. RESULTS: Comparison of the adjusted mean difference in TWSTRS total scores at Week 4 from baseline for aboBoNT-A in Trial 1 (−6.0; 95% CI, −10.8, −1.3), Trial 2 (−8.8; 95% CI, −12.9, −4.7), and Trial 3 (−8.7; 95% CI, −13.2, −4.2) showed similar, significant improvements. Dysphagia and muscle weakness patterns were comparable across the three trials, indicating that an increased dilution of aboBoNT-A does not result in an increased risk of diffusion-related adverse events. CONCLUSION: The results of these trials show that aboBoNT-A is similarly efficacious using either dilution, with similar safety and tolerability across trials. Having the 500 U/1 mL and 500 U/2 mL dilution volumes available provides further flexibility in administration, benefiting patient care.
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spelling pubmed-86368022021-12-08 AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions Lew, Mark F. Hauser, Robert A. Isaacson, Stuart H. Truong, Daniel Patel, Atul T. Brashear, Allison Ondo, William Maisonobe, Pascal Dashtipour, Khashayar Bahroo, Laxman Wietek, Stefan Clin Park Relat Disord Original Article INTRODUCTION: Cervical dystonia (CD) is a neurologic movement disorder with potentially disabling effects and significant impact on quality of life of those affected. AbobotulinumtoxinA (aboBoNT-A) was initially approved for a dilution of 500 U/1 mL and subsequently for a dilution of 500 U/2 mL, providing flexibility for clinicians to treat CD. Here, we explore the safety and efficacy of the 500 U/2 mL dilution versus 500 U/1 mL dilution of aboBoNT-A in a retrospective analysis based on published clinical trial data. METHODS: The safety and efficacy of aboBoNT-A in patients with CD was evaluated in three multicenter, double-blind, randomized, placebo-controlled trials and open-label extensions. Trials 1 (NCT00257660) and 2 (NCT00288509) evaluated the 500 U/1 mL dilution in 80 and 116 patients, respectively; Trial 3 (NCT01753310) evaluated the 500 U/2 mL dilution in 125 patients. RESULTS: Comparison of the adjusted mean difference in TWSTRS total scores at Week 4 from baseline for aboBoNT-A in Trial 1 (−6.0; 95% CI, −10.8, −1.3), Trial 2 (−8.8; 95% CI, −12.9, −4.7), and Trial 3 (−8.7; 95% CI, −13.2, −4.2) showed similar, significant improvements. Dysphagia and muscle weakness patterns were comparable across the three trials, indicating that an increased dilution of aboBoNT-A does not result in an increased risk of diffusion-related adverse events. CONCLUSION: The results of these trials show that aboBoNT-A is similarly efficacious using either dilution, with similar safety and tolerability across trials. Having the 500 U/1 mL and 500 U/2 mL dilution volumes available provides further flexibility in administration, benefiting patient care. Elsevier 2021-11-20 /pmc/articles/PMC8636802/ /pubmed/34888518 http://dx.doi.org/10.1016/j.prdoa.2021.100115 Text en © 2021 The Author(s) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Original Article
Lew, Mark F.
Hauser, Robert A.
Isaacson, Stuart H.
Truong, Daniel
Patel, Atul T.
Brashear, Allison
Ondo, William
Maisonobe, Pascal
Dashtipour, Khashayar
Bahroo, Laxman
Wietek, Stefan
AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions
title AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions
title_full AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions
title_fullStr AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions
title_full_unstemmed AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions
title_short AbobotulinumtoxinA provides flexibility for the treatment of cervical dystonia with 500 U/1 mL and 500 U/2 mL dilutions
title_sort abobotulinumtoxina provides flexibility for the treatment of cervical dystonia with 500 u/1 ml and 500 u/2 ml dilutions
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8636802/
https://www.ncbi.nlm.nih.gov/pubmed/34888518
http://dx.doi.org/10.1016/j.prdoa.2021.100115
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