Topical Glycopyrronium Tosylate for the Treatment of Primary Axillary Hyperhidrosis: Patient-Reported Outcomes from the ATMOS-1 and ATMOS-2 Phase III Randomized Controlled Trials

Abstract

Background Glycopyrronium tosylate (GT) is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years. GT was evaluated for primary axillary hyperhidrosis in replicate, randomized, double-blind, vehicle-controlled, phase III trials. GT reduced sweating severity and production versus vehicle and was generally well tolerated. Objective Our objective was to evaluate patient-reported outcomes (PROs) from these trials. Methods Patients aged ≥ 9 years with primary axillary hyperhidrosis ≥ 6 months, gravimetrically measured sweat production ≥ 50 mg/5 min in each axilla, Axillary Sweating Daily Diary (ASDD) Item 2 severity score ≥ 4, and Hyperhidrosis Disease Severity Scale (HDSS) score ≥ 3 were randomized 2:1 to GT 3.75% or vehicle applied once daily to each axilla for 4 weeks. The 4-item ASDD, 6 Weekly Impact (WI) items, Patient Global Impression of Change (PGIC), HDSS, and Dermatology Life Quality Index (DLQI) were utilized. Results In the pooled population, 463 patients were randomized to GT and 234 to vehicle; 426 (92.0%) and 225 (96.2%) completed the trials. At baseline, most patients considered their axillary sweating to be at least moderate in severity, impact, and bothersomeness (ASDD items 2, 3, and 4, respectively). Improvement was substantially greater for GT than for vehicle at every study week, and, at week 4, ASDD scores improved from baseline by 62.6 versus 34.0% (severity), 65.5 versus 40.3% (impact), and 65.4 versus 39.0% (bothersomeness). Improvements favoring GT versus vehicle also occurred for WI items, PGIC, HDSS, and DLQI. Conclusions PRO results demonstrated that GT reduced the disease burden of primary axillary hyperhidrosis. Trial registration Clinicaltrials.gov; ATMOS-1 (NCT02530281), ATMOS-2 (NCT02530294). Electronic supplementary material The online version of this article (10.1007/s40257-018-0395-0) contains supplementary material, which is available to authorized users.

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

“…These subgroup data are consistent with previous findings of individual and pooled ATMOS‐1 and ATMOS‐2 data showing that GT improved disease symptoms, severity, and quality of life vs vehicle . ASDD/ASDD‐C Item 2 responder rates were nearly identical among GT‐treated pediatric and older subgroup patients.…”

“…Though a vehicle effect was observed in these trials, GT-treated patients had a significantly greater response than that observed with vehicle. 12,19 Glycopyrronium tosylate was generally well tolerated, and TEAEs in pediatric patients were qualitatively similar to those seen in the older subgroup and consistent with those expected with anticholin- LSRs that were reported were mild in intensity.…”

“…Identical excipients were included in the vehicle comparator of the ATMOS trials to account for any potential effect due to a compound other than active drug. Though a vehicle effect was observed in these trials, GT‐treated patients had a significantly greater response than that observed with vehicle …”

Safety and efficacy of topical formulations containing 0·5, 1 and 2% glycopyrronium bromide in patients with primary axillary hyperhidrosis: a randomized, double‐blind, placebo‐controlled study

“…Onset of action was already shown on Day 2 with statistical significance compared with baseline. Similar to the findings in other studies, we also observed a high placebo rate, probably due to the complex nature of HH.…”

Topical glycopyrronium in Darier's disease

“…Glycopyrrolate is an anticholinergic agent acting on nerves innervating eccrine sweat glands and decreasing sweat production (Pariser et al, 2019). It has been used successfully in treating patients with hyperhidrosis.…”