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A new treatment for focal dystonias: incobotulinumtoxinA (Xeomin®), a botulinum neurotoxin type A free from complexing proteins

Dystonia is a movement disorder of uncertain pathogenesis that is characterized by involuntary and inappropriate muscle contractions which cause sustained abnormal postures and movements of multiple or single (focal) body regions. The most common focal dystonias are cervical dystonia (CD) and blepha...

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Autor principal: Jimenez-Shahed, Joohi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261649/
https://www.ncbi.nlm.nih.gov/pubmed/22275842
http://dx.doi.org/10.2147/NDT.S16085
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author Jimenez-Shahed, Joohi
author_facet Jimenez-Shahed, Joohi
author_sort Jimenez-Shahed, Joohi
collection PubMed
description Dystonia is a movement disorder of uncertain pathogenesis that is characterized by involuntary and inappropriate muscle contractions which cause sustained abnormal postures and movements of multiple or single (focal) body regions. The most common focal dystonias are cervical dystonia (CD) and blepharospasm (BSP). The first-line recommended treatment for CD and BSP is injection with botulinum toxin (BoNT), of which two serotypes are available: BoNT type A (BoNT/A) and BoNT type B (BoNT/B). Conventional BoNT formulations include inactive complexing proteins, which may increase the risk for antigenicity, possibly leading to treatment failure. IncobotulinumtoxinA (Xeomin(®); Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a BoNT/A agent that has been recently Food and Drug Administration-approved for the treatment of adults with CD and adults with BSP previously treated with onabotulinumtoxinA (Botox(®); Allergen, Inc, Irvine, CA) – a conventional BoNT/A. IncobotulinumtoxinA is the only BoNT product that is free of complexing proteins. The necessity of complexing proteins for the effectiveness of botulinum toxin treatment has been challenged by preclinical and clinical studies with incobotulinumtoxinA. These studies have also suggested that incobotulinumtoxinA is associated with a lower risk for stimulating antibody formation than onabotulinumtoxinA. In phase 3 noninferiority trials, incobotulinumtoxinA demonstrated significant improvements in CD and BSP symptoms in both primary and secondary measures, compared with baseline, and met criteria for noninferiority versus onabotulinumtoxinA. In placebo-controlled trials, incobotulinumtoxinA also significantly improved the symptoms of CD and BSP, with robust outcomes in both primary and secondary measures. The use of incobotulinumtoxinA has been well tolerated in all trials, with an adverse event profile similar to that of onabotulinumtoxinA. Based on these data, incobotulinumtoxinA is a safe and effective BoNT/A for the treatment of CD and BSP, and may pose a lower risk for immunogenicity leading to treatment failure compared with other available BoNT agents. This paper reviews the treatment of focal dystonias with BoNTs, in particular, incobotulinumtoxinA. Controlled trials from the existing incobotulinumtoxinA literature are summarized.
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spelling pubmed-32616492012-01-24 A new treatment for focal dystonias: incobotulinumtoxinA (Xeomin®), a botulinum neurotoxin type A free from complexing proteins Jimenez-Shahed, Joohi Neuropsychiatr Dis Treat Review Dystonia is a movement disorder of uncertain pathogenesis that is characterized by involuntary and inappropriate muscle contractions which cause sustained abnormal postures and movements of multiple or single (focal) body regions. The most common focal dystonias are cervical dystonia (CD) and blepharospasm (BSP). The first-line recommended treatment for CD and BSP is injection with botulinum toxin (BoNT), of which two serotypes are available: BoNT type A (BoNT/A) and BoNT type B (BoNT/B). Conventional BoNT formulations include inactive complexing proteins, which may increase the risk for antigenicity, possibly leading to treatment failure. IncobotulinumtoxinA (Xeomin(®); Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a BoNT/A agent that has been recently Food and Drug Administration-approved for the treatment of adults with CD and adults with BSP previously treated with onabotulinumtoxinA (Botox(®); Allergen, Inc, Irvine, CA) – a conventional BoNT/A. IncobotulinumtoxinA is the only BoNT product that is free of complexing proteins. The necessity of complexing proteins for the effectiveness of botulinum toxin treatment has been challenged by preclinical and clinical studies with incobotulinumtoxinA. These studies have also suggested that incobotulinumtoxinA is associated with a lower risk for stimulating antibody formation than onabotulinumtoxinA. In phase 3 noninferiority trials, incobotulinumtoxinA demonstrated significant improvements in CD and BSP symptoms in both primary and secondary measures, compared with baseline, and met criteria for noninferiority versus onabotulinumtoxinA. In placebo-controlled trials, incobotulinumtoxinA also significantly improved the symptoms of CD and BSP, with robust outcomes in both primary and secondary measures. The use of incobotulinumtoxinA has been well tolerated in all trials, with an adverse event profile similar to that of onabotulinumtoxinA. Based on these data, incobotulinumtoxinA is a safe and effective BoNT/A for the treatment of CD and BSP, and may pose a lower risk for immunogenicity leading to treatment failure compared with other available BoNT agents. This paper reviews the treatment of focal dystonias with BoNTs, in particular, incobotulinumtoxinA. Controlled trials from the existing incobotulinumtoxinA literature are summarized. Dove Medical Press 2012 2011-12-23 /pmc/articles/PMC3261649/ /pubmed/22275842 http://dx.doi.org/10.2147/NDT.S16085 Text en © 2012 Jimenez-Shahed, publisher and licensee Dove Medical Press Ltd. This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.
spellingShingle Review
Jimenez-Shahed, Joohi
A new treatment for focal dystonias: incobotulinumtoxinA (Xeomin®), a botulinum neurotoxin type A free from complexing proteins
title A new treatment for focal dystonias: incobotulinumtoxinA (Xeomin®), a botulinum neurotoxin type A free from complexing proteins
title_full A new treatment for focal dystonias: incobotulinumtoxinA (Xeomin®), a botulinum neurotoxin type A free from complexing proteins
title_fullStr A new treatment for focal dystonias: incobotulinumtoxinA (Xeomin®), a botulinum neurotoxin type A free from complexing proteins
title_full_unstemmed A new treatment for focal dystonias: incobotulinumtoxinA (Xeomin®), a botulinum neurotoxin type A free from complexing proteins
title_short A new treatment for focal dystonias: incobotulinumtoxinA (Xeomin®), a botulinum neurotoxin type A free from complexing proteins
title_sort new treatment for focal dystonias: incobotulinumtoxina (xeomin®), a botulinum neurotoxin type a free from complexing proteins
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261649/
https://www.ncbi.nlm.nih.gov/pubmed/22275842
http://dx.doi.org/10.2147/NDT.S16085
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