Table 2.
Baseline disease characteristics (intent-to-treat population)
| ATMOS-1 | ATMOS-2 | Pooled | ||||
|---|---|---|---|---|---|---|
| Vehicle n = 115 |
GT n = 229 |
Vehicle n = 119 |
GT n = 234 |
Vehicle n = 234 |
GT n = 463 |
|
| Years with primary axillary hyperhidrosisa | 16.0 ± 11.4 | 13.7 ± 10.4 | 15.9 ± 9.9 | 16.9 ± 11.1 | 16.0 ± 10.6 | 15.3 ± 10.9 |
| Sweat production (50 mg/5 min)a | 170.3 ± 164.2 | 182.9 ± 266.9 | 181.9 ± 160.1 | 162.3 ± 149.5 | 176.2 ± 161.9 | 172.5 ± 215.7 |
| ASDD/ASDD-C item 2 (sweating severity)a | ||||||
| Mean ± SD | 7.1 ± 1.7 | 7.3 ± 1.6 | 7.2 ± 1.6 | 7.3 ± 1.6 | 7.2 ± 1.6 | 7.3 ± 1.6 |
| Score ≥ 7 (≥ moderate), % | 55.7 | 61.1 | 60.5 | 59.4 | 58.1 | 60.3 |
| Score ≥ 9 (severe), % | 13.9 | 17.0 | 16.0 | 20.9 | 15.0 | 19.0 |
| ASDD Item 3 (impact)b | n = 109 | n = 224 | n = 109 | n = 223 | n = 218 | n = 447 |
| Mean ± SD | 2.2 ± 0.9 | 2.4 ± 0.9 | 2.3 ± 1.0 | 2.5 ± 0.8 | 2.2 ± 0.9 | 2.4 ± 0.9 |
| Score ≥ 2 (≥ moderate), % | 60.6 | 73.7 | 64.2 | 75.3 | 62.4 | 74.5 |
| Score ≥ 3 (severe), % | 22.0 | 29.5 | 30.3 | 32.3 | 26.1 | 30.9 |
| ASDD Item 4 (bothersomeness)b | n = 109 | n = 224 | n = 109 | n = 223 | n = 218 | n = 447 |
| Mean ± SD | 2.4 ± 0.9 | 2.6 ± 0.8 | 2.5 ± 0.9 | 2.7 ± 0.9 | 2.5 ± 0.9 | 2.7 ± 0.8 |
| Score ≥ 2 (≥ moderate), % | 68.8 | 82.1 | 69.7 | 81.2 | 69.3 | 81.7 |
| Score ≥ 3 (severe), % | 31.2 | 40.6 | 35.8 | 42.2 | 33.5 | 41.4 |
| Weekly Impact items,b % | n = 103 | n = 201 | n = 100 | n = 200 | n = 203 | n = 401 |
| Needed to change shirt during the day | 80.6 | 85.6 | 87.0 | 87.5 | 83.7 | 86.5 |
| Needed ≥ 1 shower/bath a day | 62.1 | 59.2 | 52.0 | 55.0 | 57.1 | 57.1 |
| Felt less confident | 86.4 | 91.0 | 93.0 | 93.0 | 89.7 | 92.0 |
| Felt embarrassed | 93.2 | 98.5 | 97.0 | 96.0 | 95.1 | 97.3 |
| Avoided interactions | 68.9 | 67.7 | 61.0 | 67.0 | 65.0 | 67.3 |
| Kept from doing an activity | 49.5 | 62.7 | 56.0 | 59.5 | 52.7 | 61.1 |
| HDSS, n (%) | ||||||
| Grade 3 | 84 (73.0) | 133 (58.1) | 71 (59.7) | 144 (61.5) | 155 (66.2) | 277 (59.8) |
| Grade 4 | 31 (27.0) | 96 (41.9) | 47 (39.5) | 90 (38.5) | 78 (33.3) | 186 (40.2) |
| DLQI (for patients > 16 years), mean ± SD [n] | 10.1 ± 5.9 [n = 108] | 12.1 ± 6.5 [n = 220] | 11.2 ± 5.8 [n = 107] | 11.6 ± 5.7 [n = 218] | 10.6 ± 5.9 [n = 215] | 11.9 ± 6.1 [n = 438] |
| CDLQI (for patients ≤ 16 years), mean ± SD [n] | 6.9 ± 3.3 [n = 7] | 8.5 ± 6.5 [n = 8] | 9.5 ± 6.5 [n = 12] | 10.6 ± 5.1 [n = 16] | 8.5 ± 5.6 [n = 19] | 9.9 ± 5.5 [n = 24] |
ASDD Axillary Sweating Daily Diary, ASDD-C children’s version of the ASDD (two items), CDLQI children’s Dermatology Life Quality Index, DLQI Dermatology Life Quality Index, GT topical glycopyrronium tosylate, HDSS Hyperhidrosis Disease Severity Scale, SD standard deviation
aMean ± standard deviation
bCompleted by patients aged ≥ 16 years