Results from a phase 3b trial indicate long-term use of 1% glycopyrronium bromide (GPB) topical treatment reduces sweat production and improves quality of life among patients with primary axillary hyperhidrosis (PAHH). These findings were published in the Journal of the European Academy of Dermatology & Venerology.
Patients (N=518) with severe PAHH were recruited in 2019 for this open-label, long-term trial (ClinicalTrials.gov Identifier: NCT03658616) of 1% GPB cream. Patients were instructed to apply 0.54 g of cream to both axillae daily for the first 4 weeks, after which point they could apply the cream a maximum of once per day and a minimum of twice per week through week 72. Sweat production was evaluated using gravimetric measurements at baseline and week 12 and patient-reported outcomes, efficacy, and safety were evaluated through week 72. Treatment response was defined as 2 points or more of improvement in Hyperhidrosis Disease Severity Scale (HDSS) score from baseline.
The study population comprised patients with a mean age of 35.6 (SD, 11.8) years, 52.9% were women, and 95.4% were White.
Sweat production decreased significantly from 212.4 mg at baseline to 75.8 mg at week 12 (P <.0001). At week 12, 28.0% of participants responded to treatment (P =.0579), reaching significance at week 28 (29.3%; P =.0112) and remaining significant through week 72 (32%; P =.0002).
Compared with baseline, by week 12, Hyperhidrosis Quality of Life Index (HidroQoL) total score (median change [MC], -11.0; 95% CI, -13.0 to -10.0; P <.0001), HidroQoL daily life activities score (MC, -5.0; 95% CI, -5.0 to -4.0; P <.0001), and HidroQoL psychosocial score (MC, -6.0; 95% CI, -7.0 to -5.0; P <.0001) improved significantly. In addition, patients reported improvement in sweating from intolerable at baseline to levels between barely tolerable and tolerable at week four (P <.0001) and to near-tolerable levels by week 72 (P <.001).
The median number of weekly applications was 7 through week 4, decreasing to 3 applications per week for the remainder of the study.
Most patients (73.2%) reported adverse events. The most common adverse drug reactions included dry mouth (12%), application site erythema (7.1%), application site pruritus (3.5%), dry eye (3.3%), and application site pain (2.1%).
A total of 150 patients terminated the study early due to withdrawal of consent (n=55), loss to follow-up (n=43), other reasons (n=36), adverse events (n=15), and death (n=1). The major limitation of this study is the proportion of patient dropout.
“…[T]he topical application of 1% GPB was well tolerated and indicates a safe long-term use in patients with severe PAHH,” the study authors wrote. “Therefore, this medicinal product was recently approved in the EU as the first topical anticholinergic for the treatment of severe primary axillary hyperhidrosis.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Szeimies R-M, Abels C, Kilic A, et al. Long-term efficacy and safety of 1% glycopyrronium bromide cream in patients with severe primary axillary hyperhidrosis: results from a Phase 3b trial. J Eur Acad Dermatol Venereol. Published online January 6, 2023. doi:10.1111/jdv.18843