Table 1. Demographic and Baseline Characteristics.
| Characteristic | Treatment groupa | |||
|---|---|---|---|---|
| Placebo (n = 78) | Abrocitinib | All (n = 391) | ||
| 100 mg (n = 158) | 200 mg (n = 155) | |||
| Age, mean (SD), y | 33.4 (13.8) | 37.4 (15.8) | 33.5 (14.7) | 35.1 (15.1) |
| Age group, y | ||||
| <18 | 8 (10.3) | 17 (10.8) | 15 (9.7) | 40 (10.2) |
| 18-64 | 69 (88.5) | 130 (82.3) | 133 (85.8) | 332 (84.9) |
| ≥65 | 1 (1.3) | 11 (7.0) | 7 (4.5) | 19 (4.9) |
| Male | 47 (60.3) | 94 (59.5) | 88 (56.8) | 229 (58.6) |
| Race | ||||
| White | 40 (51.3) | 101 (63.9) | 91 (58.7) | 232 (59.3) |
| Asian | 29 (37.2) | 46 (29.1) | 54 (34.8) | 129 (33.0) |
| Black or African American | 6 (7.7) | 9 (5.7) | 6 (3.9) | 21 (5.4) |
| Multiracial | 1 (1.3) | 1 (0.6) | 2 (1.3) | 4 (1.0) |
| Not reported | 2 (2.6) | 1 (0.6) | 2 (1.3) | 5 (1.3) |
| Ethnicity | ||||
| Not Hispanic or Latino | 73 (93.6) | 154 (97.5) | 150 (96.8) | 377 (96.4) |
| Hispanic or Latino | 2 (2.6) | 3 (1.9) | 4 (2.6) | 9 (2.3) |
| Not reported | 3 (3.8) | 1 (0.6) | 1 (0.6) | 5 (1.3) |
| Disease duration, mean (SD), y | 21.7 (14.3) | 21.1 (14.8) | 20.5 (14.8) | 21.0 (14.7) |
| Prior prescribed or OTC medication for ADb | ||||
| Any | 78 (100) | 157 (99.4) | 153 (98.7) | 388 (99.2) |
| Anti-inflammatory topical agents alone (corticosteroids, crisaborole, calcineurin inhibitors) | 46 (59.0) | 87 (55.1) | 93 (60.0) | 226 (57.8) |
| Systemic agents (corticosteroids, cyclosporin, nonbiologics), biologics, and/or topical agents | 32 (41.0) | 70 (44.3) | 60 (38.7) | 162 (41.4) |
| Dupilumab | 2 (2.6) | 7 (4.4) | 5 (3.2) | 14 (3.6) |
| IGA scorec | ||||
| 3 | 52 (66.7) | 107 (67.7) | 106 (68.4) | 265 (67.8) |
| 4 | 26 (33.3) | 51 (32.3) | 49 (31.6) | 126 (32.2) |
| EASI score, mean (SD)d | 28.0 (10.2) | 28.4 (11.2) | 29.0 (12.4) | 28.5 (11.5) |
| BSA affected, mean (SD), % | 48.2 (20.8) | 48.7 (21.4) | 47.7 (22.3) | 48.2 (21.6) |
| SCORAD | ||||
| No. of patients | 78 | 158 | 155 | 391 |
| Mean (SD) scoree | 64.3 (12.4) | 63.8 (11.4) | 64.1 (13.1) | 64.0 (12.3) |
| PP-NRS | ||||
| No. of patients | 78 | 158 | 155 | 391 |
| Mean (SD) scoref | 6.7 (1.9) | 7.1 (1.6) | 7.0 (1.6) | 7.0 (1.7) |
| PSAAD | ||||
| No. of patients | 77 | 156 | 155 | 388 |
| Mean (SD) total scoreg | 5.1 (2.1) | 5.4 (2.1) | 5.2 (2.0) | 5.2 (2.1) |
| DLQIh | ||||
| No. of patients | 70 | 140 | 139 | 349 |
| Mean (SD) total scorei | 15.0 (7.1) | 15.4 (7.3) | 14.8 (6.0) | 15.0 (6.8) |
| CDLQIj | ||||
| No. of patients | 8 | 16 | 15 | 39 |
| Mean (SD) total scorek | 10.1 (3.8) | 13.8 (5.8) | 12.9 (5.7) | 12.7 (5.4) |
| POEM | ||||
| No. of patients | 78 | 156 | 154 | 388 |
| Mean (SD) total scorel | 19.2 (5.5) | 20.9 (5.7) | 19.7 (5.7) | 20.1 (5.7) |
| HADS | ||||
| Anxiety | ||||
| No. of patients | 78 | 156 | 153 | 387 |
| Mean (SD) scorem | 6.0 (3.7) | 5.5 (4.2) | 5.9 (3.9) | 5.7 (4.0) |
| Depression | ||||
| No. of patients | 78 | 156 | 153 | 387 |
| Mean (SD) scoren | 4.4 (3.3) | 4.1 (4.0) | 4.0 (3.7) | 4.1 (3.8) |
Abbreviations: AD, atopic dermatitis; BSA, body surface area; CDLQI, Children’s Dermatology Life Quality Index (DLQI); EASI, Eczema Area and Severity Index; HADS, Hospital Anxiety and Depression Scale; IGA, Investigator’s Global Assessment; OTC, over-the-counter; POEM, Patient-Oriented Eczema Measure; PP-NRS, Peak Pruritus Numerical Rating Scale; PSAAD, Pruritus and Symptoms Assessment for Atopic Dermatitis; SCORAD, Scoring of Atopic Dermatitis index.
Unless otherwise indicated, data are expressed as number (percentage) of patients.
Patients were counted once for each main category in an exclusive manner, with systemic agents, biologics, and/or topical agents taking precedence over anti-inflammatory topical agents alone.
Scores range from 0 (clear) to 4 (severe), with 3 indicating moderate.
Scores range from 0 to 72, with higher scores indicating greater extent and severity of atopic dermatitis.
Scores range from 0 to 103, with higher scores indicating greater extent and severity of atopic dermatitis.
Scores range from 0 to 10, with higher scores indicating worse itch.
Scores range from 0 to 10, with higher scores indicating worse daily symptoms of atopic dermatitis.
For patients 18 years or older.
Scores range from 0 to 30, with higher scores indicating worse quality of life.
For patients aged younger than 18 years.
Scores range from 0 to 30, with higher scores indicating worst quality of life.
Scores range from 0 to 28, with higher scores indicating higher severity of atopic dermatitis.
Scores range from 0 to 21, with higher scores indicating increased anxiety.
Scores range from 0 to 21, with higher scores indicating increased depression.