Table 1. Baseline Demographics and Disease Characteristics.
| Characteristic | Patients, No. (%) | |
|---|---|---|
| Placebo group (n = 56) | Ixekizumab group (n = 115) | |
| Age, mean (SD), y | 13.1 (2.8) | 13.7 (3.1) |
| Sex | ||
| Female | 36 (64.3) | 63 (54.8) |
| Male | 20 (35.7) | 52 (45.2) |
| Racea | ||
| American Indian or Alaska Native | 0 | 2 (1.8) |
| Asian | 2 (3.8) | 4 (3.5) |
| Black or African American | 3 (5.7) | 3 (2.6) |
| White race | 45 (84.9) | 95 (83.3) |
| Multiple | 3 (5.7) | 10 (8.8) |
| Weight, mean (SD), kg | 60.3 (20.3) | 63.9 (24.9) |
| <25 | 1 (2.0) | 2 (2.0) |
| ≥25 to ≤50 | 14 (25.0) | 29 (25.0) |
| >50 | 41 (73.0) | 84 (73.0) |
| BMI, mean (SD) | 23.5 (5.6) | 24.1 (6.8) |
| Duration of psoriasis since diagnosis, mean (SD), y | 4.7 (3.0) | 4.7 (3.3) |
| Previous psoriasis treatment | ||
| Nonbiologic systemic | 15 (27.0) | 39 (34.0) |
| Biologic | 2 (4.0) | 5 (4.0) |
| Phototherapy | 13 (23.0) | 25 (22.0) |
| BSA, mean (SD), % | 27.1 (17.3) | 27.1 (18.6) |
| sPGA score, mean (SD) | 3.5 (0.6) | 3.6 (0.6) |
| 3 | 31 (55.0) | 57 (50.0) |
| 4 | 21 (38.0) | 51 (44.0) |
| 5 | 4 (7.0) | 7 (6.0) |
| PASI, mean (SD) | 19.7 (8.0) | 19.8 (7.5) |
| NAPSI, mean (SD)b | 24.5 (20.9) | 33.9 (29.5) |
| >0 | 12.0 (21.0) | 34.0 (30.0) |
| PSSI, mean (SD)c | 29.7 (17.2) | 27.3 (17.0) |
| >0 | 50.0 (89.0) | 102.0 (89.0) |
| PPASI, mean (SD)d | 15.4 (21.1) | 8.2 (8.7) |
| >0 | 9.0 (16.0) | 17.0 (15.0) |
| Itch NRS score, mean (SD) | 5.0 (2.5) | 5.4 (2.8) |
| ≥4 | 40.0 (71.0) | 83.0 (72.0) |
| CDLQI, mean (SD)e | 7.4 (4.8) | 8.5 (5.5) |
| DLQI, mean (SD)f | 10.2 (5.42) | 9.3 (4.9) |
| PatGA score, mean (SD) | 3.5 (0.9) | 3.6 (1.1) |
| >0 | 56 (100) | 115 (100) |
| Presence of genital psoriasis | 14 (25.0) | 41 (36.0) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); BSA, body surface area; CDLQI, Children’s Dermatology Life Quality Index; DLQI, Dermatology Life Quality Index; NAPSI, Nail Psoriasis Severity Index; NRS, Numeric Rating Scale; PASI, Psoriasis Area and Severity Index; PatGA, Patient’s Global Assessment of Disease Severity; PPASI, Palmoplantar Psoriasis Area and Severity Index; PSSI, Psoriasis Scalp Severity Index; sPGA, static Physician’s Global Assessment.
Race was self-reported by participants to the trial investigators at each site; 4 patients did not report the data. Data were calculated with 53 patients in the placebo group and 114 patients in the ixekizumab group.
Assessed for patients with nail psoriasis at baseline (as reported by the investigator). No. of patients with nonmissing values: n = 13, placebo group; n = 34, ixekizumab group.
Assessed for patients with scalp psoriasis at baseline (as reported by the investigator). No. of patients with nonmissing values: n = 50, placebo group; n = 103, ixekizumab group.
Assessed for patients with palmoplantar psoriasis at baseline (as reported by the investigator). No. of patients with nonmissing values: n = 9, placebo group; n = 18, ixekizumab group.
Assessed in patients aged 6 to 16 years. No. of patients with nonmissing values: n = 48, placebo group; n = 86, ixekizumab group.
Assessed in patients 17 years of age or older. No. of patients with nonmissing values: n = 6, placebo group; n = 26, ixekizumab group.