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

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.

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

“…These trials included additional PRO measures and a post hoc analysis comparing pediatric (#16 years) and older patients ([16 years), which showed no impact of age on primary efficacy outcomes. 21,22 Topical, once-daily GT may provide a noninvasive, well-tolerated treatment option for primary axillary hyperhidrosis.…”

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

“…The pediatric sample size in this trial was small, and further study in younger patients will be useful. It should be noted that post hoc analyses of the pediatric patient population from the double-blind, lead-in trials [11] and this open-label extension [17] show an advantage with GT across multiple efficacy measures and favorable tolerability, with similar findings in children and adults. Because of the different study designs, it is not advisable to directly compare the present long-term results with those of other drugs used to treat axillary hyperhidrosis, including other anticholinergic medications, and GT efficacy and safety data beyond 48 weeks of treatment cannot be extrapolated from the results of this trial.…”

“…Glycopyrronium tosylate is formulated as a topical solution and applied once daily to the axillae using a pre-moistened towelette. Results from the two randomized, 4-week, double-blind, vehicle (VEH)-controlled, phase III studies of GT for primary axillary hyperhidrosis (ATMOS-1 [NCT02530281] and ATMOS-2 [NCT02530294]) have previously been reported [9–11]. In these trials, GT was generally well tolerated and significantly reduced sweating severity and sweat production compared with VEH along with corresponding improvements in quality of life through 4 weeks of treatment.…”

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

“…In Hebert et al, the standard age cutoff for ASDD‐C was published with error. It should be <16 years instead of <6 years.…”