Table 1.
Demographic and baseline disease characteristics (randomized set)
|
SEC LD (N = 40) |
SEC HD (N = 40) |
Placebo (N = 41) |
Etanercept (N = 41) |
Total (N = 162) |
|
|---|---|---|---|---|---|
| Age group (years), n (%) | |||||
| <12 | 8 (20.0) | 9 (22.5) | 10 (24.4) | 10 (24.4) | 37 (22.8) |
| ≥12 | 32 (80.0) | 31 (77.5) | 31 (75.6) | 31 (75.6) | 125 (77.2) |
| Age (years), mean (SD) | 13.7 (2.92) | 13.2 (3.21) | 13.7 (3.27) | 13.5 (2.94) | 13.5 (3.06) |
| Sex, n (%) | |||||
| Male | 13 (32.5) | 17 (42.5) | 19 (46.3) | 16 (39.0) | 65 (40.1) |
| Female | 27 (67.5) | 23 (57.5) | 22 (53.7) | 25 (61.0) | 97 (59.9) |
| Race, Caucasian, n (%) | 34 (85.0) | 34 (85.0) | 36 (87.8) | 30 (73.2) | 134 (82.7) |
| Weight (kg), mean (SD) | 52.60 (15.26) | 53.61 (20.18) | 55.68 (22.28) | 51.96 (19.43) | 53.47 (19.35) |
| Weight strata (kg), n (%) | |||||
| <25 | 2 (5.0) | 3 (7.5) | 3 (7.3) | 4 (9.8) | 12 (7.4) |
| 25 to <50 | 17 (42.5) | 15 (37.5) | 17 (41.5) | 16 (39.0) | 65 (40.1) |
| ≥50 | 21 (52.5) | 22 (55.0) | 21 (51.2) | 21 (51.2) | 85 (52.5) |
| BMI (kg/m2), mean (SD) | 20.32 (3.60) | 21.16 (4.37) | 22.19 (6.20) | 21.00 (4.80) | 21.17 (4.85) |
| Baseline PASI score, mean (SD) | 27.6 (6.89) | 28.0 (8.67) | 28.0 (8.09) | 28.4 (9.05) | 28.0 (8.15) |
| Baseline PASI, n (%) | |||||
| ≤20 | 0 (0.0) | 1 (2.5) | 0 (0.0) | 0 (0.0) | 1 (0.6) |
| >20 | 40 (100.0) | 39 (97.5) | 41 (100.0) | 41 (100.0) | 161 (99.4) |
| Baseline total BSA, mean (SD) | 37.59 (13.86) | 40.26 (17.56) | 38.99 (17.65) | 43.13 (19.56) | 40.01 (17.26) |
| Baseline IGA Mod 2011 score, n (%) | |||||
| 3 = moderate disease | 0 (0.0) | 1 (2.5) | 0 (0.0) | 0 (0.0) | 1 (0.6) |
| 4 = severe disease | 40 (100.0) | 39 (97.5) | 41 (100.0) | 41 (100.0) | 161 (99.4) |
| Time since diagnosis of plaque psoriasis (years), mean (SD) | 4.85 (4.29) | 5.44 (4.67) | 6.03 (5.09) | 4.55 (3.73) | 5.22 (4.47) |
| Diagnosis of psoriatic arthritis, n (%) | 5 (12.5) | 3 (7.5) | 3 (7.3) | 3 (7.3) | 14 (8.6) |
| Previous psoriasis therapies, n (%) | |||||
| Systemic | 26 (65.0) | 21 (52.5) | 20 (48.8) | 19 (46.3) | 86 (53.1) |
| Biologic | 3 (7.5) | 0 (0.0) | 0 (0.0) | 1 (2.4) | 4 (2.5) |
| Non‐biologic systemic | 26 (65.0) | 21 (52.5) | 20 (48.8) | 18 (43.9) | 85 (52.5) |
| Topical | 32 (80.0) | 36 (90.0) | 38 (92.7) | 38 (92.7) | 144 (88.9) |
| Phototherapy | 16 (40.0) | 16 (40.0) | 21 (51.2) | 17 (41.5) | 70 (43.2) |
| Photochemotherapy | 3 (7.5) | 11 (27.5) | 1 (2.4) | 5 (12.2) | 20 (12.3) |
BMI, body mass index; BSA, body surface area; HD, high dose; IGA mod 2011, Investigator’s Global Assessment Modified 2011; LD, low dose; PASI, Psoriasis Area and Severity Index; SD, standard deviation; SEC, secukinumab.