Long‐term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44‐week open‐label extension study

摘要

Abstract Background/Objectives Glycopyrronium tosylate (GT) cloth, 2.4% is a topical anticholinergic approved in the United States for primary axillary hyperhidrosis in patients ≥9?years. This post hoc analysis evaluated long‐term response (efficacy and safety) in pediatric patients (≥9 to ≤16?years) to GT in the 44‐week, open‐label extension (NCT02553798) of two, phase 3, double‐blind, vehicle‐controlled, 4‐week trials (NCT02530281, NCT02530294). Methods In the double‐blind trials, patients ≥9?years with primary axillary hyperhidrosis were randomized 2:1 to once‐daily GT:vehicle. Those who completed the study could receive open‐label GT for up to an additional 44?weeks. Safety assessments included treatment‐emergent adverse events (TEAEs) and local skin reactions (LSRs). Descriptive efficacy assessments included gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale response (≥2‐grade improvement), and Children's Dermatology Life Quality Index. Results Of 43 pediatric patients completing either double‐blind trial, 38 (88.4%) entered the open‐label extension (age, years: 9 [n?=?1], 12 [n?=?2], 13 [n?=?7], 14 and 15 [n?=?9 each], 16?[n?=?10]). The safety profile observed was similar to the double‐blind trials. Most TEAEs (95%) were mild/moderate, related to anticholinergic activity, and infrequently led to discontinuation (n?=?1/38 [2.6%]). No pediatric patients experienced a serious TEAE. Most anticholinergic TEAEs did not require a dose modification and resolved within 7?days. Approximately, one‐third of patients (n?=?13/38 [34.2%]) had LSRs; most were mild/moderate in severity. Improvements in efficacy measures were maintained from the double‐blind trials. Conclusions Long‐term, once‐daily GT for up to 48?weeks (4‐week double‐blind plus 44?week open label) provides a noninvasive, well‐tolerated treatment option for pediatric patients with primary axillary hyperhidrosis.