Burden of axillary hyperhidrosis using a patient-reported outcome measure to assess impact on activities and bothersomeness


Burden of axillary hyperhidrosis using a patient-reported outcome measure to assess impact on activities and bothersomeness

Presenters: Pariser DM1, Hebert AA2, Drew J3, Quiring J4, Glaser DA5

Affiliations: 1Eastern Virginia Medical School and Virginial Clinical Research, Inc., Norfolk, VA; 2UTHealth McGovern Medical School, Houston, TX; 3Dermira, Inc., Menlo Park, CA; 4QST Consultations, Allendale, MI; 5Saint Louis University, St. Louis, MO

Introduction: Hyperhidrosis affects approximately 4.8 percent of the United States population, and approximately three-quarters of patients experience a negative psychological impact. Anxiety and depression are over 3.5 times more common among hyperhidrosis sufferers. The Axillary Hyperhidrosis Patient Measures (AHPM)­—the four-item Axillary Sweating Daily Diary (ASDD), two-item, child-specific version of ASDD [ASDD-C] for patients at least nine years old but less than 16 years old, six Weekly Impact (WI) items, and single-item Patient Global Impression of Change (PGIC)—were developed in consultation with the United States Food and Drug Administration (FDA) and in consideration of FDA patient-reported outcomes (PRO) guidance. Baseline values from two Phase III trials of an investigational axillary hyperhidrosis treatment, topical glycopyrronium tosylate (GT; formerly DRM04), were evaluated to characterize the burden of disease.

Methods: ATMOS 1 (DRM04-HH04, NCT02530281) and ATMOS 2 (DRM04 HH05, NCT02530294) were randomized, double-blind Phase III trials. Patients at least nine years of age with primary axillary hyperhidrosis for at least six months, gravimetrically measured sweat production of at least 50mg per five minutes in each axilla, ASDD axillary sweating severity item (Item 2) 4 or above (numeric rating scale 0 to 10), and Hyperhidrosis Disease Severity Scale (HDSS) Grade 3 or above were randomized 2:1 to GT or vehicle applied once-daily to each axilla for 28 days. Item 1 assessed the presence of underarm sweating and acted as a gatekeeper question for Item 2. ASDD Items 3 and 4 assessed impact and bother of axillary sweating (numeric rating scale 0–4). WI Items assessed the impact of axillary sweating (needing to change shirt during the day, needing to bathe at least once a day, feeling less confident, feeling embarrassed, avoiding interactions, kept from doing an activity on a weekly basis). ASDD items were scored as a weekly average of daily responses. Baseline ASDD item scores and proportion of patients with positive responses to WI items are reported.

Results: Among 697 randomized patients, 665 were at least 16 years of age and were asked Items 3 and 4 and WI items. For ASDD Item 2, 59.3 percent and 59.8 percent of patients had a score of 7 or above (moderately severe sweating) at baseline in ATMOS-1 and ATMOS-2, respectively. For Item 3, 69.4 percent and 71.7 percent had a score of 2 (moderate impact) or above. For Item 4, 77.8 percent and 77.4 percent had a score of 2 (moderate bother) or above. In both studies, a majority of patients reported being impacted by their excess sweating, with most having to avoid interactions or take additional measures (e.g., bathing more than once a day, changing shirts during the day) due to excessive sweating. Over 96 percent of patients experienced embarrassment due to underarm sweating.

Conclusion: In this analysis, over 69 percent and 77 percent of patients reported feeling moderately impacted and bothered by their axillary hyperhidrosis during daily activities at baseline. Nearly all patients (>96%) reported embarrassment, underscoring previously reported negative psychological impact of this underreported and underdiagnosed condition.