Table 3.
Patient-reported outcomes: change from baseline (ASDD items, DLQI/CDLQI) and at week 4 (HDSS Responder Rate, Weekly Impact items and PGIC)
| ATMOS-1 | ATMOS-2 | |||
|---|---|---|---|---|
| Vehicle | GT | Vehicle | GT | |
| Primary efficacy PRO outcomea | ||||
| ASDD/ASDD-C Item 2 (sweating severity) responder rate (≥ 4-point improvement from baseline), % of patients | 28.3 [n = 115] | 52.8*** [n = 229] | 26.9 [119] | 66.1*** [234] |
| Supportive efficacy PRO outcomesb | ||||
| HDSS responder rate (≥ 2-grade improvement from baseline)a, % of patients | 23.7% [n = 115] | 56.5*** [n = 229] | 27.8 [n = 119] | 61.6*** [n = 234] |
| ASDD/ASDD-C Item 2 (sweating severity), mean % improvement from BL | n = 115 | n = 229 | n = 119 | n = 234 |
| Week 1 | 15.1 | 31.1 | 16.9 | 36.9 |
| Week 2 | 25.4 | 48.8 | 26.5 | 55.4 |
| Week 3 | 30.3 | 54.8 | 34.8 | 62.4 |
| Week 4 | 31.2 | 57.8 | 35.2 | 64.1 |
| ASDD Item 3 (impact), mean % improvement from BL | ||||
| Week 1 | 17.3 [n = 106] | 33.8 [n = 212] | 20.3 [n = 102] | 42.8 [n = 212] |
| Week 2 | 30.0 [n = 102] | 49.6 [n = 207] | 31.1 [n = 94] | 63.3 [n = 200] |
| Week 3 | 33.8 [n = 101] | 53.3 [n = 193] | 41.5 [n = 99] | 68.9 [n = 195] |
| Week 4 | 38.2 [n = 98] | 60.2 [n = 186] | 42.6 [n = 93] | 70.9 [n = 183] |
| ASDD Item 4 (bothersomeness), mean % improvement from BL | ||||
| Week 1 | 15.8 [n = 107] | 36.9 [n = 215] | 19.0 [n = 105] | 43.6 [n = 213] |
| Week 2 | 29.2 [n = 103] | 54.3 [n = 210] | 32.3 [n = 97] | 63.3 [n = 201] |
| Week 3 | 32.4 [n = 102] | 60.8 [n = 196] | 40.9 [n = 101] | 67.6 [n = 196] |
| Week 4 | 34.2 [n = 99] | 62.7 [n = 189] | 44.1 [n = 96] | 68.1 [n = 184] |
| WI items at week 4, % of patients | n = 109 | n = 224 | n = 109 | n = 222 |
| Needed to change shirt during the day | 50.5 | 32.1 | 55.0 | 22.5 |
| Needed ≥1 shower/bath a day | 43.1 | 23.7 | 24.8 | 14.9 |
| Felt less confident | 58.7 | 38.8 | 61.5 | 33.3 |
| Felt embarrassed | 63.3 | 43.8 | 67.0 | 39.2 [n = 221] |
| Avoided interactions | 34.9 | 17.9 | 34.9 | 15.8 |
| Kept from doing an activity | 21.1 | 13.8 | 31.2 | 10.8 |
| PGIC at week 4,** % of patients | n = 115 | n = 229 | n = 119 | n = 234 |
| Score = 1 Much better | 17.6 | 52.3 | 26.0 | 63.7 |
| Score = 2 Moderately better | 20.6 | 21.3 | 14.6 | 16.7 |
| Score = 3 A little better | 32.4 | 17.8 | 22.9 | 14.2 |
| Score = 4 No Difference | 24.5 | 8.1 | 32.3 | 4.9 |
| Score = 5, 6 or 7 A little to much worsec | 4.9 | 0.5 | 4.2 | 0.5 |
| DLQI, change from BL to week 4, mean ± SD [n] | − 4.3 ± 5.9 [n = 105] | − 8.1 ± 5.8*** [n = 202] | − 5.0 ± 6.2 [n = 101] | − 8.6 ± 6.2*** [n = 203] |
| CDLQI, change from BL to week 4, mean ± SD [n] | − 1.6 ± 3.7 [n = 7] | − 7.5 ± 6.1 [n = 8] | − 2.1 ± 6.5 [n = 12] | − 8.4 ± 5.2* [n = 15] |
ANCOVA analysis of covariance, ASDD Axillary Sweating Daily Diary, ASDD-C children’s version of the ASDD (two items), BL baseline, CDLQI children’s Dermatology Life Quality Index, DLQI Dermatology Life Quality Index, GT topical glycopyrronium tosylate, HDSS Hyperhidrosis Disease Severity Scale, PGIC Patient Global Impression of Change, PRO patient-reported outcome, SD standard deviation, WI Weekly Impact
*p < 0.05 for GT vs. vehicle at week 4 from an ANCOVA with factors of treatment group and analysis center and a covariate of baseline score
**p < 0.01 for GT vs. vehicle for both trials from an ANCOVA with factors of treatment group and analysis center
***p < 0.001 for GT vs. vehicle at week 4. For ASDD/ASDD-C Item 2 and HDSS responder rates, the analysis was a Cochran–Mantel–Haenszel test stratified by analysis center. For DLQI/CDLQI, the analysis was an ANCOVA with factors of treatment group and analysis center and a covariate of baseline score
aPrespecified statistical comparison
bNo prespecified statistical analysis was performed for ASDD Items 3, 4, and WI items; prespecified analyses were performed for DLQI/CLQI, while a post hoc statistical comparison was performed for PGIC
cFor the PGIC, no patients in either the ATMOS-1 or ATMOS-2 trials rated their change as “moderately worse” (score = 6) or “much worse” (score = 7); therefore, these categories were combined with the category of “a little worse” (score = 5)