Table 1. Baseline Demographics and Disease Characteristics in the Modified Intent-to-Treat Populationa.
| Variable | No. (%) | |||
|---|---|---|---|---|
| Placebo Every 2 wk (n = 52) | Lebrikizumab | |||
| 125 mg Every 4 wk (n = 73) | 250 mg Every 4 wk (n = 80) | 250 mg Every 2 wk (n = 75) | ||
| Baseline Demographics | ||||
| Age, mean (SD), y | 42.2 (18.2) | 36.7 (16.5) | 40.2 (17.9) | 38.9 (17.4) |
| Female | 24 (46.2) | 46 (63.0) | 47 (58.8) | 49 (65.3) |
| Race/ethnicity | ||||
| White | 26 (50.0) | 37 (50.7) | 42 (52.5) | 40 (53.3) |
| Black or African American | 16 (30.8) | 26 (35.6) | 28 (35.0) | 23 (30.7) |
| American Indian or Alaskan native | 0 | 1 (1.4) | 1 (1.3) | 1 (1.3) |
| Asian | 6 (11.5) | 8 (11.0) | 7 (8.8) | 6 (8.0) |
| Multiple or other | 4 (7.7) | 1 (1.4) | 2 (2.5) | 5 (6.7) |
| Ethnicity | ||||
| Hispanic or Latino | 5 (9.6) | 14 (19.2) | 11 (13.8) | 12 (16.0) |
| Not Hispanic or Latino | 47 (90.4) | 59 (80.8) | 69 (86.3) | 63 (84.0) |
| BMI, mean (SD) | 29.7 (8.0) | 30.1 (7.7) | 29.2 (6.9) | 28.1 (6.4) |
| Baseline Disease Characteristics | ||||
| Disease duration, mean (SD), y | 24.4 (17.4) | 22.8 (15.4) | 23.3 (16.7)b | 22.1 (17.2) |
| Prior dupilumab use | 4 (7.7) | 4 (5.5) | 3 (3.8) | 5 (6.7) |
| IGA | ||||
| 3, Moderate | 32 (61.5) | 43 (58.9) | 54 (67.5) | 53 (70.7) |
| 4, Severe | 20 (38.5) | 30 (41.1) | 26 (32.5) | 22 (29.3) |
| EASI, mean (SD) | 28.9 (11.8) | 29.9 (13.5) | 26.2 (10.1) | 25.5 (11.2) |
| Pruritus NRS score, mean (SD)c | 7.4 (2.4) | 7.6 (2.0) | 7.1 (2.4) | 7.6 (1.9) |
| Sleep loss NRS score, mean (SD)d | 1.8 (1.2) | 2.1 (1.0) | 2.0 (1.2) | 2.2 (1.2) |
| BSA involvement, mean (SD), % | 46.5 (22.7) | 45.5 (24.5) | 41.1 (20.9) | 39.4 (21.5) |
| POEM total score, mean (SD) | 19.4 (6.8) | 21.5 (5.7)e | 19.9 (6.7) | 20.4 (5.7) |
| DLQI, mean (SD) | 14.1 (7.1) | 14.5 (7.1)e | 14.2 (7.7) | 14.1 (6.9) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); BSA, body surface area; DLQI, Dermatology Life Quality Index (range, 0 [no effect of skin disease on quality of life] to 30 [maximum effect on quality of life]); EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment (5-point scale); NRS, numeric rating scale; POEM, Patient-Oriented Eczema Measure (range, 0 [clear] to 28 [very severe]).
Percentages are based on the number of patients in the modified intent-to-treat population with a nonmissing response.
Sample size is n = 79.
Sample sizes are as follows: n = 49 for placebo and n = 68, n = 77, and n = 69 for the 3 lebrikizumab groups, respectively.
Sample sizes are as follows: n = 49 for placebo and n = 68, n = 77, and n = 70 for the 3 lebrikizumab groups, respectively. Sleep loss NRS scores reflect interference of itch on sleep over the past 24 hours on a 5-point scale (0 indicates not at all, and 4 indicates unable to sleep at all).
Sample size is n = 72.