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A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis

BACKGROUND: Glycopyrronium tosylate is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years (Qbrexza™ [glycopyrronium] cloth, 2.4%). OBJECTIVE: This 44-week open-label extension study assessed glycopyrronium tosylate safety and descriptive effic...

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Autores principales: Glaser, Dee Anna, Hebert, Adelaide A., Nast, Alexander, Werschler, William P., Green, Lawrence, Mamelok, Richard D., Quiring, John, Drew, Janice, Pariser, David M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6687675/
https://www.ncbi.nlm.nih.gov/pubmed/31111409
http://dx.doi.org/10.1007/s40257-019-00446-6
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author Glaser, Dee Anna
Hebert, Adelaide A.
Nast, Alexander
Werschler, William P.
Green, Lawrence
Mamelok, Richard D.
Quiring, John
Drew, Janice
Pariser, David M.
author_facet Glaser, Dee Anna
Hebert, Adelaide A.
Nast, Alexander
Werschler, William P.
Green, Lawrence
Mamelok, Richard D.
Quiring, John
Drew, Janice
Pariser, David M.
author_sort Glaser, Dee Anna
collection PubMed
description BACKGROUND: Glycopyrronium tosylate is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years (Qbrexza™ [glycopyrronium] cloth, 2.4%). OBJECTIVE: This 44-week open-label extension study assessed glycopyrronium tosylate safety and descriptive efficacy in patients completing one of two, phase III, double-blind, vehicle-controlled, 4-week trials (NCT02530281; NCT02530294). METHODS: Patients aged ≥ 9 years with primary axillary hyperhidrosis were randomized 2:1 (glycopyrronium tosylate: vehicle, once daily) in the double-blind trials. Completers could receive open-label glycopyrronium tosylate for up to an additional 44 weeks. Treatment-emergent adverse events and local skin reactions were assessed. Descriptive efficacy assessments were gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale responder rate (≥ 2 grade improvement), and Dermatology Life Quality Index/children’s Dermatology Life Quality Index. RESULTS: Of 651 patients completing the double-blind trials, 564 (86.6%) entered the open-label extension; 550 were analyzed. Most patients experiencing treatment-emergent adverse events had mild or moderate events (> 90%). Discontinuation because of treatment-emergent adverse events remained low and relatively stable, with a cumulative rate of 8.0% (44/550) over 44 weeks. Common treatment-emergent adverse events (> 5%) were dry mouth (16.9%), vision blurred (6.7%), application-site pain (6.4%), nasopharyngitis (5.8%), and mydriasis (5.3%). Most patients (67.5%) had no local skin reactions; those occurring were predominantly mild/moderate. Glycopyrronium tosylate efficacy was maintained throughout the trial; at week 44, the Hyperhidrosis Disease Severity Scale responder rate was 63.2%, and improvements from baseline (double blind) in sweat production were − 71.3% and 8.7 ± 6.2/6.2 ± 4.9 for Dermatology Life Quality Index/children’s Dermatology Life Quality Index. CONCLUSIONS: Daily long-term application of glycopyrronium tosylate for up to 48 weeks (double blind plus open label) was generally well tolerated and efficacy was maintained. No new safety signals emerged. TRIAL REGISTRY: Clinicaltrials.gov NCT02553798. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40257-019-00446-6) contains supplementary material, which is available to authorized users.
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spelling pubmed-66876752019-08-23 A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis Glaser, Dee Anna Hebert, Adelaide A. Nast, Alexander Werschler, William P. Green, Lawrence Mamelok, Richard D. Quiring, John Drew, Janice Pariser, David M. Am J Clin Dermatol Original Research Article BACKGROUND: Glycopyrronium tosylate is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years (Qbrexza™ [glycopyrronium] cloth, 2.4%). OBJECTIVE: This 44-week open-label extension study assessed glycopyrronium tosylate safety and descriptive efficacy in patients completing one of two, phase III, double-blind, vehicle-controlled, 4-week trials (NCT02530281; NCT02530294). METHODS: Patients aged ≥ 9 years with primary axillary hyperhidrosis were randomized 2:1 (glycopyrronium tosylate: vehicle, once daily) in the double-blind trials. Completers could receive open-label glycopyrronium tosylate for up to an additional 44 weeks. Treatment-emergent adverse events and local skin reactions were assessed. Descriptive efficacy assessments were gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale responder rate (≥ 2 grade improvement), and Dermatology Life Quality Index/children’s Dermatology Life Quality Index. RESULTS: Of 651 patients completing the double-blind trials, 564 (86.6%) entered the open-label extension; 550 were analyzed. Most patients experiencing treatment-emergent adverse events had mild or moderate events (> 90%). Discontinuation because of treatment-emergent adverse events remained low and relatively stable, with a cumulative rate of 8.0% (44/550) over 44 weeks. Common treatment-emergent adverse events (> 5%) were dry mouth (16.9%), vision blurred (6.7%), application-site pain (6.4%), nasopharyngitis (5.8%), and mydriasis (5.3%). Most patients (67.5%) had no local skin reactions; those occurring were predominantly mild/moderate. Glycopyrronium tosylate efficacy was maintained throughout the trial; at week 44, the Hyperhidrosis Disease Severity Scale responder rate was 63.2%, and improvements from baseline (double blind) in sweat production were − 71.3% and 8.7 ± 6.2/6.2 ± 4.9 for Dermatology Life Quality Index/children’s Dermatology Life Quality Index. CONCLUSIONS: Daily long-term application of glycopyrronium tosylate for up to 48 weeks (double blind plus open label) was generally well tolerated and efficacy was maintained. No new safety signals emerged. TRIAL REGISTRY: Clinicaltrials.gov NCT02553798. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40257-019-00446-6) contains supplementary material, which is available to authorized users. Springer International Publishing 2019-05-20 2019 /pmc/articles/PMC6687675/ /pubmed/31111409 http://dx.doi.org/10.1007/s40257-019-00446-6 Text en © The Author(s) 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research Article
Glaser, Dee Anna
Hebert, Adelaide A.
Nast, Alexander
Werschler, William P.
Green, Lawrence
Mamelok, Richard D.
Quiring, John
Drew, Janice
Pariser, David M.
A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis
title A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis
title_full A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis
title_fullStr A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis
title_full_unstemmed A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis
title_short A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis
title_sort 44-week open-label study evaluating safety and efficacy of topical glycopyrronium tosylate in patients with primary axillary hyperhidrosis
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6687675/
https://www.ncbi.nlm.nih.gov/pubmed/31111409
http://dx.doi.org/10.1007/s40257-019-00446-6
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