Cargando…

Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact

Hyperhidrosis (chronic excessive sweating) may substantially affect an individual’s emotional and social well-being. Therapies available before onabotulinumtoxinA were generally topical, with limited effectiveness, application-site skin reactions, and frequent, time-consuming treatments. Intradermal...

Descripción completa

Detalles Bibliográficos
Autores principales: Lowe, Nicholas, Naumann, Markus, Eadie, Nina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10374185/
https://www.ncbi.nlm.nih.gov/pubmed/37499084
http://dx.doi.org/10.1097/MD.0000000000032764
_version_ 1785078722626322432
author Lowe, Nicholas
Naumann, Markus
Eadie, Nina
author_facet Lowe, Nicholas
Naumann, Markus
Eadie, Nina
author_sort Lowe, Nicholas
collection PubMed
description Hyperhidrosis (chronic excessive sweating) may substantially affect an individual’s emotional and social well-being. Therapies available before onabotulinumtoxinA were generally topical, with limited effectiveness, application-site skin reactions, and frequent, time-consuming treatments. Intradermal injection of onabotulinumtoxinA to treat sweat glands arose as a novel therapeutic approach. To develop this treatment, appropriate dosing needed to be established, and training on administration was required. Further, no previous scale existed to measure the effects of hyperhidrosis on patients’ lives, leading Allergan to develop and validate the 4-point Hyperhidrosis Disease Severity Scale (HDSS), which measures the disease’s impact on daily activities. The onabotulinumtoxinA clinical development program for hyperhidrosis included 2 double-blind, placebo-controlled pivotal trials, immunogenicity studies, long-term studies of safety and efficacy, and quality of life assessments. In Europe and North America, the primary efficacy measures were, respectively, axillary sweat production measured gravimetrically and HDSS improvement. Compared with placebo, onabotulinumtoxinA treatment significantly reduced axillary sweat production and axillary hyperhidrosis severity, as measured by a 2-point or greater reduction on the HDSS. The effects of onabotulinumtoxinA occurred rapidly, within 1 week after injection, and lasted ≥6 months. Treatment with onabotulinumtoxinA was associated with significant quality of life improvements based on Short Form-12 physical and mental component scores. The Hyperhidrosis Impact Questionnaire also indicated greater treatment satisfaction, reduced negative impact on aspects of daily life, and improved emotional well-being with onabotulinumtoxinA versus placebo. The clinical development program and subsequent clinical experience showed that onabotulinumtoxinA treatment for hyperhidrosis was well tolerated with no new safety signals, and led to greater disease awareness.
format Online
Article
Text
id pubmed-10374185
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Lippincott Williams & Wilkins
record_format MEDLINE/PubMed
spelling pubmed-103741852023-07-28 Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact Lowe, Nicholas Naumann, Markus Eadie, Nina Medicine (Baltimore) OA Supplement Article Hyperhidrosis (chronic excessive sweating) may substantially affect an individual’s emotional and social well-being. Therapies available before onabotulinumtoxinA were generally topical, with limited effectiveness, application-site skin reactions, and frequent, time-consuming treatments. Intradermal injection of onabotulinumtoxinA to treat sweat glands arose as a novel therapeutic approach. To develop this treatment, appropriate dosing needed to be established, and training on administration was required. Further, no previous scale existed to measure the effects of hyperhidrosis on patients’ lives, leading Allergan to develop and validate the 4-point Hyperhidrosis Disease Severity Scale (HDSS), which measures the disease’s impact on daily activities. The onabotulinumtoxinA clinical development program for hyperhidrosis included 2 double-blind, placebo-controlled pivotal trials, immunogenicity studies, long-term studies of safety and efficacy, and quality of life assessments. In Europe and North America, the primary efficacy measures were, respectively, axillary sweat production measured gravimetrically and HDSS improvement. Compared with placebo, onabotulinumtoxinA treatment significantly reduced axillary sweat production and axillary hyperhidrosis severity, as measured by a 2-point or greater reduction on the HDSS. The effects of onabotulinumtoxinA occurred rapidly, within 1 week after injection, and lasted ≥6 months. Treatment with onabotulinumtoxinA was associated with significant quality of life improvements based on Short Form-12 physical and mental component scores. The Hyperhidrosis Impact Questionnaire also indicated greater treatment satisfaction, reduced negative impact on aspects of daily life, and improved emotional well-being with onabotulinumtoxinA versus placebo. The clinical development program and subsequent clinical experience showed that onabotulinumtoxinA treatment for hyperhidrosis was well tolerated with no new safety signals, and led to greater disease awareness. Lippincott Williams & Wilkins 2023-07-01 /pmc/articles/PMC10374185/ /pubmed/37499084 http://dx.doi.org/10.1097/MD.0000000000032764 Text en Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND) (https://creativecommons.org/licenses/by-nc-nd/4.0/) , where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
spellingShingle OA Supplement Article
Lowe, Nicholas
Naumann, Markus
Eadie, Nina
Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact
title Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact
title_full Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact
title_fullStr Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact
title_full_unstemmed Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact
title_short Treatment of hyperhidrosis with Botox (onabotulinumtoxinA): Development, insights, and impact
title_sort treatment of hyperhidrosis with botox (onabotulinumtoxina): development, insights, and impact
topic OA Supplement Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10374185/
https://www.ncbi.nlm.nih.gov/pubmed/37499084
http://dx.doi.org/10.1097/MD.0000000000032764
work_keys_str_mv AT lowenicholas treatmentofhyperhidrosiswithbotoxonabotulinumtoxinadevelopmentinsightsandimpact
AT naumannmarkus treatmentofhyperhidrosiswithbotoxonabotulinumtoxinadevelopmentinsightsandimpact
AT eadienina treatmentofhyperhidrosiswithbotoxonabotulinumtoxinadevelopmentinsightsandimpact