Table 1. Demographic and Baseline Characteristics.
| Characteristic | Placebo (n = 56) | Abrocitinib | |||
|---|---|---|---|---|---|
| 10 mg (n = 49) | 30 mg (n = 51) | 100 mg (n = 56) | 200 mg (n = 55) | ||
| Safety Analysis Set a | |||||
| Age, mean (SD), y | 42.6 (15.1) | 44.3 (15.9) | 37.6 (15.9) | 41.1 (15.6) | 38.7 (17.6) |
| Male sex, No. (%) | 21 (37.5) | 21 (42.9) | 22 (43.1) | 31 (55.4) | 28 (50.9) |
| Race, No. (%) | |||||
| White | 40 (71.4) | 38 (77.6) | 39 (76.5) | 40 (71.4) | 37 (67.3) |
| Black | 10 (17.9) | 5 (10.2) | 4 (7.8) | 7 (12.5) | 13 (23.6) |
| Asian | 4 (7.1) | 5 (10.2) | 5 (9.8) | 8 (14.3) | 5 (9.1) |
| Other | 2 (3.6) | 1 (2.0) | 3 (5.9) | 1 (1.8) | 0 |
| BMI, mean (SD) | 27.1 (5.9) | 28.2 (7.8) | 27.3 (5.6) | 28.0 (6.1) | 28.6 (7.3) |
| Disease duration, median (range), y | 25.6 (1.1-67.1) | 30.2 (1.8-60.6) | 20.5 (1.2-66.6) | 23.8 (1.1-66.7) | 19.6 (1.9-68.8) |
| Full Analysis Set b | (n = 55) | (n = 49) | (n = 50) | (n = 55) | (n = 54) |
| EASI, mean (SD) | 25.4 (12.9) | 28.1 (13.1) | 22.1 (10.7) | 26.7 (11.8) | 24.6 (13.5) |
| %BSA, mean (SD) | 40.1 (22.3) | 44.2 (22.7) | 34.1 (20.8) | 41.9 (22.3) | 38.0 (23.3) |
| IGA grade, No. (%) | |||||
| Moderate (3) | 34 (61.8) | 27 (55.1) | 28 (56.0) | 29 (52.7) | 34 (63.0) |
| Severe (4) | 21 (38.2) | 22 (44.9) | 22 (44.0) | 26 (47.3) | 20 (37.0) |
| SCORAD Index score, mean (SD) | 65.0 (12.1) | 65.3 (13.2) | 62.4 (13.0) | 65.4 (13.7) | 62.7 (13.7) |
| Pruritus NRS score, mean (SD)c | 7.6 (1.8) | 7.6 (1.7) | 7.6 (1.9) | 7.4 (2.2) | 6.9 (2.7) |
Abbreviations: %BSA, percentage of body surface area; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, numeric rating scale; SCORAD, Scoring Atopic Dermatitis.
Safety analysis set included all patients who received 1 dose or more of abrocitinib or placebo.
Full analysis set included all patients who received 1 dose or more of abrocitinib or placebo, except for 4 patients who were excluded because of major protocol deviations.
Pruritus NRS data not available for 14 patients (52 patients in placebo group, 45 patients in 10-mg group, 48 patients in 30-mg group, 55 patients in 100-mg group, and 53 patients in 200-mg group).