Table 1.
Baseline patient demographics and disease characteristics
| Crisaborole | |||
|---|---|---|---|
| Non-PK cohort N = 116 |
PK cohort N = 21 |
Total N = 137 |
|
| Age (months) | |||
| 3 to < 9, n (%) | 36 (31.0) | 7 (33.3) | 43 (31.4) |
| 9 to < 24, n (%) | 80 (69.0) | 14 (66.7) | 94 (68.6) |
| Mean (SD) | 13.7 (6.41) | 12.7 (6.58) | 13.6 (6.42) |
| Median (range) | 13.5 (3–23) | 13.0 (3–23) | 13.0 (3–23) |
| Sex, n (%) | |||
| Male | 75 (64.7) | 13 (61.9) | 88 (64.2) |
| Female | 41 (35.3) | 8 (38.1) | 49 (35.8) |
| Race, n (%) | |||
| White | 71 (61.2) | 13 (61.9) | 84 (61.3) |
| Black or African American | 9 (7.8) | 2 (9.5) | 11 (8.0) |
| Asian | 23 (19.8) | 4 (19.0) | 27 (19.7) |
| American Indian or Alaskan native | 1 (0.9) | 0 | 1 (0.7) |
| Native Hawaiian or other Pacific Islander | 1 (0.9) | 0 | 1 (0.7) |
| Multiracial | 11 (9.5) | 2 (9.5) | 13 (9.5) |
| ISGA | |||
| 2—Mild, n (%) | 52 (44.8) | 0 | 52 (38.0) |
| 3—Moderate, n (%) | 64 (55.2) | 20 (95.2) | 84 (61.3) |
| 4—Severe,a n (%) | 0 | 1 (4.8) | 1 (0.7) |
| Mean (SD) | 2.6 (0.50) | 3.0 (0.22) | 2.6 (0.50) |
| Median (range) | 3.0 (2–3) | 3.0 (3–4) | 3.0 (2–4) |
| POEM total score | |||
| Mean (SD) | 13.9 (5.86) | 19.7 (5.18) | 14.8 (6.12) |
| Median (range) | 14.0 (1–24) | 20.0 (9–27) | 15.0 (1–27) |
| EASI score | |||
| Mean (SD) | 10.4 (8.16) | 19.8 (4.42) | 11.8 (8.41) |
| Median (range) | 7.8 (1.6–38.8) | 19.5 (12.5–29.2) | 8.9 (1.6–38.8) |
| %BSA | |||
| Mean (SD) | 23.5 (20.13) | 53.5 (12.61) | 28.1 (22.00) |
| Median (range) | 15.5 (5.0–94.0) | 56.0 (35.0–79.0) | 19.0 (5.0–94.0) |
| Duration since onset (months) | |||
| Mean (SD) | 10.4 (6.44) | 9.1 (5.48) | 10.2 (6.3) |
| Median (range) | 9.4 (0.03–23.8) | 8.1 (1.4–21.0) | 8.6 (0.03–23.8) |
| Medical history of other atopic conditions,b n (%) | 21 (18.1) | 1 (4.8) | 22 (16.1) |
| Prior medication use, n (%) | |||
| TCS | 63 (54.3) | 9 (49.2) | 72 (52.6) |
| TCI | 2 (1.7) | 0 | 2 (1.5) |
%BSA percentage of treatable body surface area, EASI Eczema Area and Severity Index, ISGA Investigator’s Static Global Assessment, PK pharmacokinetics, POEM Patient-Oriented Eczema Measure, SD standard deviation, TCI topical calcineurin inhibitor, TCS topical corticosteroid
aProtocol deviation
bIncludes conditions such as asthma, food allergies, and allergic/seasonal rhinitis