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A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis.
Am J Clin Dermatol 2019; 20(4):593-604AJ

Abstract

BACKGROUND

Glycopyrronium tosylate is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years (Qbrexza™ [glycopyrronium] cloth, 2.4%).

OBJECTIVE

This 44-week open-label extension study assessed glycopyrronium tosylate safety and descriptive efficacy in patients completing one of two, phase III, double-blind, vehicle-controlled, 4-week trials (NCT02530281; NCT02530294).

METHODS

Patients aged ≥ 9 years with primary axillary hyperhidrosis were randomized 2:1 (glycopyrronium tosylate: vehicle, once daily) in the double-blind trials. Completers could receive open-label glycopyrronium tosylate for up to an additional 44 weeks. Treatment-emergent adverse events and local skin reactions were assessed. Descriptive efficacy assessments were gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale responder rate (≥ 2 grade improvement), and Dermatology Life Quality Index/children's Dermatology Life Quality Index.

RESULTS

Of 651 patients completing the double-blind trials, 564 (86.6%) entered the open-label extension; 550 were analyzed. Most patients experiencing treatment-emergent adverse events had mild or moderate events (> 90%). Discontinuation because of treatment-emergent adverse events remained low and relatively stable, with a cumulative rate of 8.0% (44/550) over 44 weeks. Common treatment-emergent adverse events (> 5%) were dry mouth (16.9%), vision blurred (6.7%), application-site pain (6.4%), nasopharyngitis (5.8%), and mydriasis (5.3%). Most patients (67.5%) had no local skin reactions; those occurring were predominantly mild/moderate. Glycopyrronium tosylate efficacy was maintained throughout the trial; at week 44, the Hyperhidrosis Disease Severity Scale responder rate was 63.2%, and improvements from baseline (double blind) in sweat production were - 71.3% and 8.7 ± 6.2/6.2 ± 4.9 for Dermatology Life Quality Index/children's Dermatology Life Quality Index.

CONCLUSIONS

Daily long-term application of glycopyrronium tosylate for up to 48 weeks (double blind plus open label) was generally well tolerated and efficacy was maintained. No new safety signals emerged.

TRIAL REGISTRY

Clinicaltrials.gov NCT02553798.

Authors+Show Affiliations

Saint Louis University, 1755 S. Grand Blvd, St. Louis, MO, 63104, USA. glasermd@slu.edu.UTHealth McGovern Medical School, Houston, TX, USA.Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany. Division of Evidence-Based Medicine, Department of Dermatology, Venerology und Allergy, Berlin Institute of Health, Berlin, Germany.Premier Clinical Research, Spokane, WA, USA.George Washington University School of Medicine, Washington, DC, USA.Mamelok Consulting, Palo Alto, CA, USA.QST Consultations, Allendale, MI, USA.Dermira, Inc., Menlo Park, CA, USA.Eastern Virginia Medical School, Virginia Clinical Research, Inc., Norfolk, VA, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31111409

Citation

Glaser, Dee Anna, et al. "A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients With Primary Axillary Hyperhidrosis." American Journal of Clinical Dermatology, vol. 20, no. 4, 2019, pp. 593-604.
Glaser DA, Hebert AA, Nast A, et al. A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis. Am J Clin Dermatol. 2019;20(4):593-604.
Glaser, D. A., Hebert, A. A., Nast, A., Werschler, W. P., Green, L., Mamelok, R. D., ... Pariser, D. M. (2019). A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis. American Journal of Clinical Dermatology, 20(4), pp. 593-604. doi:10.1007/s40257-019-00446-6.
Glaser DA, et al. A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients With Primary Axillary Hyperhidrosis. Am J Clin Dermatol. 2019;20(4):593-604. PubMed PMID: 31111409.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis. AU - Glaser,Dee Anna, AU - Hebert,Adelaide A, AU - Nast,Alexander, AU - Werschler,William P, AU - Green,Lawrence, AU - Mamelok,Richard D, AU - Quiring,John, AU - Drew,Janice, AU - Pariser,David M, PY - 2019/5/22/pubmed PY - 2019/5/22/medline PY - 2019/5/22/entrez SP - 593 EP - 604 JF - American journal of clinical dermatology JO - Am J Clin Dermatol VL - 20 IS - 4 N2 - BACKGROUND: Glycopyrronium tosylate is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years (Qbrexza™ [glycopyrronium] cloth, 2.4%). OBJECTIVE: This 44-week open-label extension study assessed glycopyrronium tosylate safety and descriptive efficacy in patients completing one of two, phase III, double-blind, vehicle-controlled, 4-week trials (NCT02530281; NCT02530294). METHODS: Patients aged ≥ 9 years with primary axillary hyperhidrosis were randomized 2:1 (glycopyrronium tosylate: vehicle, once daily) in the double-blind trials. Completers could receive open-label glycopyrronium tosylate for up to an additional 44 weeks. Treatment-emergent adverse events and local skin reactions were assessed. Descriptive efficacy assessments were gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale responder rate (≥ 2 grade improvement), and Dermatology Life Quality Index/children's Dermatology Life Quality Index. RESULTS: Of 651 patients completing the double-blind trials, 564 (86.6%) entered the open-label extension; 550 were analyzed. Most patients experiencing treatment-emergent adverse events had mild or moderate events (> 90%). Discontinuation because of treatment-emergent adverse events remained low and relatively stable, with a cumulative rate of 8.0% (44/550) over 44 weeks. Common treatment-emergent adverse events (> 5%) were dry mouth (16.9%), vision blurred (6.7%), application-site pain (6.4%), nasopharyngitis (5.8%), and mydriasis (5.3%). Most patients (67.5%) had no local skin reactions; those occurring were predominantly mild/moderate. Glycopyrronium tosylate efficacy was maintained throughout the trial; at week 44, the Hyperhidrosis Disease Severity Scale responder rate was 63.2%, and improvements from baseline (double blind) in sweat production were - 71.3% and 8.7 ± 6.2/6.2 ± 4.9 for Dermatology Life Quality Index/children's Dermatology Life Quality Index. CONCLUSIONS: Daily long-term application of glycopyrronium tosylate for up to 48 weeks (double blind plus open label) was generally well tolerated and efficacy was maintained. No new safety signals emerged. TRIAL REGISTRY: Clinicaltrials.gov NCT02553798. SN - 1179-1888 UR - https://www.unboundmedicine.com/medline/citation/31111409/A_44-Week_Open-Label_Study_Evaluating_Safety_and_Efficacy_of_Topical_Glycopyrronium_Tosylate_in_Patients_with_Primary_Axillary_Hyperhidrosis L2 - https://dx.doi.org/10.1007/s40257-019-00446-6 DB - PRIME DP - Unbound Medicine ER -