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Clinical Trial
. 2019 Jan;36(1):89-99.
doi: 10.1111/pde.13723. Epub 2018 Nov 19.

Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials

Adelaide A Hebert  1 , Dee Anna Glaser  2 , Lawrence Green  3 , William P Werschler  4 , Douglass W Forsha  5 , Janice Drew  6 , Ramanan Gopalan  6 , David M Pariser  7
Affiliations
Clinical Trial

Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials

Adelaide A Hebert et al. Pediatr Dermatol. 2019 Jan.

Erratum in

Abstract

Objectives: Hyperhidrosis in pediatric patients has been understudied. Post hoc analyses of two phase 3 randomized, vehicle-controlled, 4-week trials (ATMOS-1 [NCT02530281] and ATMOS-2 [NCT02530294]) were performed to assess efficacy and safety of topical anticholinergic glycopyrronium tosylate (GT) in pediatric patients.

Methods: Patients had primary axillary hyperhidrosis ≥ 6 months, average Axillary Sweating Daily Diary (ASDD/ASDD-Children [ASDD-C]) Item 2 (sweating severity) score ≥ 4, sweat production ≥ 50 mg/5 min (each axilla), and Hyperhidrosis Disease Severity Scale (HDSS) ≥ 3. Coprimary end points were ≥ 4-point improvement on ASDD/ASDD-C Item 2 (a validated patient-reported outcome) and change in gravimetrically measured sweat production at Week 4. Efficacy and safety data are shown through Week 4 for the pediatric (≥ 9 to ≤ 16 years) vs older (> 16 years) subgroups.

Results: Six hundred and ninety-seven patients were randomized in ATMOS-1/ATMOS-2 (GT, N = 463; vehicle, N = 234); 44 were ≥ 9 to ≤ 16 years (GT, n = 25; vehicle, n = 19). Baseline disease characteristics were generally similar across subgroups. GT-treated pediatric vs older patients had comparable improvements in ASDD/ASDD-C Item 2 (sweating severity) responder rate, HDSS responder rate (≥ 2-grade improvement]), sweat production, and quality of life (mean change from Baseline in Dermatology Life Quality Index [DLQI]/children's DLQI), with greater improvement vs vehicle. Treatment-emergent adverse events were similar between subgroups, and most were mild, transient, and infrequently led to discontinuation.

Conclusions: Topical, once-daily GT improved disease severity (ASDD/ASDD-C, HDSS), sweat production, and quality of life (DLQI), with similar findings in children, adults, and the pooled population. GT was well tolerated, and treatment-emergent adverse events were qualitatively similar between subgroups and consistent with other anticholinergics.

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Conflict of interest statement

Dr. Hebert is a consultant for Dermira, Inc., and an employee of the UTHealth McGovern Medical School, Houston, which received compensation from Dermira, Inc., for study participation. Dr. Glaser is a consultant for Dermira, Inc., and an investigator for Allergan; Atacama Therapeutics; Brickell Biotech, Inc.; Galderma; and Revance Therapeutics, Inc. She has received honoraria for consulting with Allergan and Dermira, Inc. Dr. Green is an investigator for Brickell Biotech, Inc., and an advisory board member and investigator for Dermira, Inc. Dr. Werschler is a consultant and investigator for Dermira, Inc. Dr. Forsha is an investigator for Jordan Valley Dermatology and Research Center. Ms. Drew and Dr. Gopalan are employees of Dermira, Inc. Dr. Pariser received honoraria for consulting for Atacama Therapeutics; Brickell Biotech, Inc.; Biofrontera AG; Celgene Corporation; Dermira, Inc.; DUSA Pharmaceuticals, Inc.; LEO Pharma, Inc.; Novartis Pharmaceuticals Corporation; Promius Pharma; LLC; Regeneron Pharmaceuticals, Inc.; Sanofi; TDM SurgiTech, Inc.; TheraVida, Inc.; and Valeant Pharmaceuticals International, Inc. He received honoraria for advisory board participation for Pfizer, Inc. He received grants/research funding for serving as an investigator for Abbott Laboratories; Amgen, Inc.; Asana BioSciences; LLC; Brickell Biotech Inc.; Celgene Corporation; Dermavant Sciences, Inc.; Eli Lilly and Company; LEO Pharma, Inc.; Merck & Company, Inc.; Novartis Pharmaceuticals Corporation; Novo Nordisk A/S; Ortho Dermatologics, Inc.; Peplin, Inc.; Photocure ASA; Promius Pharma; LLC; Regeneron Pharmaceuticals, Inc.; Stiefel Laboratories; and Valeant Pharmaceuticals International, Inc. He received honoraria for serving as an investigator for LEO Pharma, Inc., and Pfizer, Inc.

Figures

Figure 1
Figure 1
Study design

  1. a ET for ATMOS‐1 and ATMOS‐2.

  2. bGravimetrically measured.

Patients not continuing in the open‐label extension (ARIDO) had a safety follow‐up at Week 5 via telephone. ASDD, axillary sweating daily diary; ASDD‐C, ASDD‐Children; ET, end of treatment; GT, topical glycopyrronium tosylate; Wk, week
Figure 2
Figure 2
Patient disposition.

  1. aPatient had five drug‐related events that led to discontinuation: mild vision blurred (bilateral), severe mydriasis (bilateral), severe dry mouth, severe urinary retention, and severe anhidrosis.

GT, topical glycopyrronium tosylate
Figure 3
Figure 3
ASDD/ASDD‐C Item 2 responder rate (≥ 4‐point improvement). A, At Week 4. B, To Week 4. Intent‐to‐treat population. P‐values not calculated as these comparisons were post hoc and not designed or powered to detect differences. Multiple imputation (MCMC) was used to impute missing values for Weeks 1‐4. ASDD, Axillary Sweating Daily Diary; ASDD‐C, ASDD‐Children; BL, baseline; GT, topical glycopyrronium tosylate; MCMC, Markov chain Monte Carlo
Figure 4
Figure 4
Proportion of patients with ≥ 50% reduction in sweat productiona to Week 4.

  1. aGravimetrically measured average from the left and right axillae.

Intent‐to‐treat population. P‐values not calculated as these comparisons were post hoc and not designed or powered to detect differences.Multiple imputation (MCMC) was used to impute missing values for Weeks 1‐4. GT, topical glycopyrronium tosylate; MCMC, Markov chain Monte Carlo
Figure 5
Figure 5
Hyperhidrosis Disease Severity Scale responder rate (≥ 2‐grade improvement). A, At Week 4. B. To Week 4. Intent‐to‐treat population. P‐values not calculated as these comparisons were post hoc and not designed or powered to detect differences. Multiple imputation (MCMC) was used to impute missing values for Weeks 1‐4. GT, topical glycopyrronium tosylate; MCMC, Markov chain Monte Carlo
Figure 6
Figure 6
Mean change from Baseline at Week 4 in DLQI or CDLQI. Intent‐to‐treat population. P‐values not calculated as these comparisons were post hoc and not designed or powered to detect differences. No imputation of missing values. BL, baseline; CDLQI, children's DLQI; DLQI, dermatology life quality index; GT, topical glycopyrronium tosylate
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