Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Results from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials - 13/12/18
, Adelaide A. Hebert, MD b, Alexander Nast, MD c, William P. Werschler, MD d, Lawrence Green, MD e, Richard Mamelok, MD f, Janice Drew, MPH g, John Quiring, PhD h, David M. Pariser, MD iAbstract |
Background |
Glycopyrronium tosylate (GT) is a topical anticholinergic developed for once-daily treatment of primary axillary hyperhidrosis.
Objective |
Assess the efficacy and safety of GT for primary axillary hyperhidrosis.
Methods |
ATMOS-1 and ATMOS-2 were replicate randomized, double-blind, vehicle-controlled, 4-week phase 3 trials. Patients were randomized 2:1 to GT 3.75% or vehicle applied once daily to each axilla for 4 weeks. Coprimary endpoints were responder rate (≥4-point improvement from baseline) on item 2 (severity of sweating) of the Axillary Sweating Daily Diary (ASDD), which is a newly developed patient-reported outcome measure, and absolute change from baseline in axillary gravimetric sweat production at week 4. Safety evaluation included treatment-emergent adverse events.
Results |
Pooled data, which are consistent with the individual trial results, show that significantly more GT-treated patients achieved an ASDD-Item 2 response than did those treated with vehicle (59.5% vs 27.6%), and they had reduced sweat production from baseline (–107.6 mg/5 min vs –92.1 mg/5 min) at week 4 (P < .001 for both coprimary end points). Most treatment-emergent adverse events were mild or moderate and infrequently led to discontinuation.
Limitations |
Short trial duration and inherent challenges in gravimetrically assessing sweat production.
Conclusions |
GT applied topically on a daily basis over 4 weeks reduced the severity of sweating as measured by ASDD-Item 2, reduced sweat production as measured gravimetrically, and was generally well tolerated in patients with primary axillary hyperhidrosis.
Le texte complet de cet article est disponible en PDF.Key words : anticholinergic, axilla, cholinergic receptor, DRM04, glycopyrronium tosylate, hyperhidrosis, sweat
Abbreviations used : AHPM, ASDD, ASDD-C, CfB, FDA, GT, HDSS, LSR, PRO, TEAE
Plan
| Funding sources: Sponsored and funded by Dermira, Inc. All costs associated with the development of this article were funded by Dermira, Inc. |
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| Disclosure: Dr Glaser is a consultant and investigator for Dermira, Inc. Dr Hebert is an investigator for and has received research funding from Dermira, Inc (paid to the UTHealth McGovern Medical School, Houston); he has received honoraria for advisory board membership from Dermira, Inc, and has also received research funding (all monies paid to the UTHealth McGovern Medical School, Houston) from the following: Allergan, Plc.; Amgen, Inc; Cassiopea; Celgene; Dermavant Sciences; Eli Lilly and Company; Galderma S.A.; GSK, Plc; LEO Pharma; Mayne Pharma; Medimetriks Pharmaceuticals; Novan, Inc; Promius Pharma, LLC; Vanda Pharmaceuticals. In addition, Dr Hebert has received honoraria from Amgen; GSK, Plc; Pfizer, Inc; and Valeant Pharmaceutics International, Inc. Dr Nast is an employee of Charité–Universitätsmedizin Berlin, which has received compensation from Dermira, Inc, for his participation in this study; in addition, he has received honoraria from Boehringer Ingelheim for advisory board participation and honoraria from Bayer and Novartis for educational activities. Dr Nast has also received research funding for his services as an investigator from Eli Lilly and Company; Pfizer, Inc; GSK, Plc; and MEDA. Dr Werschler is a consultant and investigator: Dermira, Inc. Dr Green is an investigator for Brickell and an advisory Board member and investigator for Dermira, Inc. Dr Mamelok is a consultant to Dermira, Inc. Ms Drew is an employee of Dermira, Inc. Dr Quiring is an employee of QST Consultations. Dr Pariser has received honoraria for serving as a consultant to Brickell Biotech, Inc; Biofrontera AG; Celgene; Dermira, Inc; DUSA Pharmaceuticals, Inc; LEO Pharma; Novartis; Promius Pharma, LLC; Regeneron Pharmaceuticals, Inc; Sanofi; TheraVida, Inc; and Valeant Pharmaceuticals International, Inc. Dr Pariser has also received honoraria for advisory board participation from Pfizer, Inc, and he has received grants/research funding from the following companies for his work as an investigator: Abbott Laboratories; Amgen, Inc; Brickell Biotech, Inc; Celgene; Dermavant Sciences; Eli Lilly and Company; LEO Pharma; Merck & Co, Inc; Novartis; Novo Nordisk A/S; Ortho Dermatologics; Peplin, Inc; Photocure ASA; Promius Pharma, LLC; Regeneron Pharmaceuticals, Inc; Stiefel Laboratories; and Valeant Pharmaceuticals International, Inc. Dr Pariser has also received honoraria from LEO Pharma and Pfizer, Inc, for his work as an investigator. |
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| Limited data were presented in abstract/poster form at the 25th Annual Meeting of the European Academy of Dermatology and Venereology, Vienna, Austria, September 28-October 2, 2016; the 26th Annual Meeting of the European Academy of Dermatology and Venereology, Geneva, Switzerland, September 13-17, 2017; and the Annual Meeting of the American Academy of Dermatology, San Diego, CA, February 16-20, 2018. |
Vol 80 - N° 1
P. 128 - janvier 2019 Retour au numéro
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