A new treatment for focal dystonias: incobotulinumtoxinA (Xeomin®), a botulinum neurotoxin type A free from complexing proteins
Joohi Jimenez-ShahedDepartment of Neurology, Baylor College of Medicine, Houston, TX, USAAbstract: 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...
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Dove Medical Press
2011
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oai:doaj.org-article:798f4f67d7994e27a77c07077ecddca32021-12-02T03:00:45ZA new treatment for focal dystonias: incobotulinumtoxinA (Xeomin®), a botulinum neurotoxin type A free from complexing proteins1176-63281178-2021https://doaj.org/article/798f4f67d7994e27a77c07077ecddca32011-12-01T00:00:00Zhttp://www.dovepress.com/a-new-treatment-for-focal-dystonias-incobotulinumtoxina-xeominreg-a-bo-a8944https://doaj.org/toc/1176-6328https://doaj.org/toc/1178-2021Joohi Jimenez-ShahedDepartment of Neurology, Baylor College of Medicine, Houston, TX, USAAbstract: 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.Keywords: blepharospasm, botulinum toxin, cervical dystonia, complexing proteins, dystonia, incobotulinumtoxinA (Xeomin®)Jimenez-Shahed JDove Medical PressarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2012, Iss default, Pp 13-25 (2011) |
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Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 |
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Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Jimenez-Shahed J A new treatment for focal dystonias: incobotulinumtoxinA (Xeomin®), a botulinum neurotoxin type A free from complexing proteins |
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Joohi Jimenez-ShahedDepartment of Neurology, Baylor College of Medicine, Houston, TX, USAAbstract: 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.Keywords: blepharospasm, botulinum toxin, cervical dystonia, complexing proteins, dystonia, incobotulinumtoxinA (Xeomin®) |
format |
article |
author |
Jimenez-Shahed J |
author_facet |
Jimenez-Shahed J |
author_sort |
Jimenez-Shahed J |
title |
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_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_sort |
new treatment for focal dystonias: incobotulinumtoxina (xeomin®), a botulinum neurotoxin type a free from complexing proteins |
publisher |
Dove Medical Press |
publishDate |
2011 |
url |
https://doaj.org/article/798f4f67d7994e27a77c07077ecddca3 |
work_keys_str_mv |
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