Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Results from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled.

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Presentation transcript:

Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Results from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials Dee Anna Glaser, MD, Adelaide A. Hebert, MD, Alexander Nast, MD, William P. Werschler, MD, Lawrence Green, MD, Richard Mamelok, MD, Janice Drew, MPH, John Quiring, PhD, David M. Pariser, MD Journal of the American Academy of Dermatology Volume 80, Issue 1, Pages 128-138.e2 (January 2019) DOI: 10.1016/j.jaad.2018.07.002 Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 Hyperhidrosis: study design. For subjects not enrolling in ARIDO, telephone follow-up occurred in week 5 to record adverse events and concomitant medications. aGravimetrically measured. ASDD, Axillary Sweating Daily Diary; ASDD-C, Axillary Sweating Daily Diary-Children; ET, end of treatment for ATMOS-1 and ATMOS-2; GT, glycopyrronium tosylate. Journal of the American Academy of Dermatology 2019 80, 128-138.e2DOI: (10.1016/j.jaad.2018.07.002) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

Fig 2 Hyperhidrosis: study design and patient disposition. GT, Glycopyrronium tosylate. Journal of the American Academy of Dermatology 2019 80, 128-138.e2DOI: (10.1016/j.jaad.2018.07.002) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

Fig 3 Hyperhidrosis: proportion of patients with at least a 4-point improvement from baseline on the Axillary Sweating Daily Diary/Axillary Sweating Daily Diary-Children Item 2 (sweating severity). Data are for the intent-to-treat population. The Markov chain Monte Carlo method was used for multiple imputation of missing data; P value was calculated for glycopyrronium tosylate (GT) versus vehicle by using of the Cochran-Mantel-Haenszel test with stratification by analysis center at week 4 (P values were calculated only for week 4; the P values for the pooled analysis are nominal). **P < .001. Journal of the American Academy of Dermatology 2019 80, 128-138.e2DOI: (10.1016/j.jaad.2018.07.002) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

Fig 4 Hyperhidrosis: proportion of patients with at least a 2-grade improvement from baseline on the Hyperhidrosis Disease Severity Scale. Data are for the intent-to-treat population. The Markov chain Monte Carlo method was used for multiple imputation of missing data; P value was calculated for glycopyrronium tosylate (GT) versus vehicle with use of the Cochran-Mantel-Haenszel test stratified by analysis center at week 4 (P values were calculated only for week 4; P values for the pooled analysis are nominal). **P < .001. Journal of the American Academy of Dermatology 2019 80, 128-138.e2DOI: (10.1016/j.jaad.2018.07.002) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

Fig 5 Hyperhidrosis: proportion of patients with a 50% or greater reduction from baseline in sweat production. Sweat production was measured gravimetrically (average of both axillae). Data are for the intent-to-treat population. The Markov chain Monte Carlo method was used for multiple imputation of missing data. P value was calculated for glycopyrronium tosylate (GT) versus vehicle with use of the Cochran-Mantel-Haenszel test stratified by analysis center at week 4 (P values were calculated only for week 4; P values for the pooled analysis are nominal). **P < .001. Journal of the American Academy of Dermatology 2019 80, 128-138.e2DOI: (10.1016/j.jaad.2018.07.002) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions

Supplemental Fig 1 Axillary hyperhidrosis patient measures. The Axillary Sweating Daily Diary/Axillary Sweating Daily Diary-Children Item 2 is a validated patient-reported outcome measure. Journal of the American Academy of Dermatology 2019 80, 128-138.e2DOI: (10.1016/j.jaad.2018.07.002) Copyright © 2018 American Academy of Dermatology, Inc. Terms and Conditions