Table 2.
Demographics and baseline characteristics of the subjects included in the risankizumab population-pharmacokinetic analysis
| Characteristic | Study 1 (n = 31) | Study 2 (n = 126) | Study 3 (n = 115) | Overall (n = 272) |
|---|---|---|---|---|
| Population | Psoriasis | Psoriasis | Crohn’s disease | |
| Sex, n (%) | ||||
| Male | 25 (80.7) | 82 (65.1) | 45 (39.1) | 152 (55.9) |
| Female | 6 (19.3) | 44 (34.9) | 70 (60.9) | 120 (44.1) |
| Race, n (%) | ||||
| White | 28 (90.3) | 117 (92.9) | 97 (84.3) | 242 (89.0) |
| Black | 2 (6.5) | 4 (3.1) | 1 (0.9) | 7 (2.6) |
| Hispanic | 0 (0.0) | 2 (1.6) | 17 (14.8) | 19 (7.0) |
| Asian | 1 (3.2) | 1 (0.8) | 0 (0.0) | 2 (0.7) |
| American Indian/Alaska Native | 0 (0.0) | 2 (1.6) | 0 (0.0) | 2 (0.7) |
| Age, year, median (range) | 45 (24–61) | 47 (20–72) | 35 (19–74) | 42.5 (19–74) |
| Body weight, kg, median (range) | 89 (47–121) | 89 (49–138) | 66 (36–126) | 79 (36–138) |
| Treatment-emergent ADAs, n (%) | ||||
| No | 28 (90.3) | 108 (85.7) | 106 (92.2) | 242 (89.0) |
| Yes | 3 (9.7) | 18 (14.3) | 9 (7.8) | 30 (11.0) |
| Albumin, g/L, median (range) | NA | 42 (34–51) | 37 (24–46) | 40 (24–51) |
| C-reactive protein, mg/L, median (range) | 3.3 (0.3–34.4) | 2.6 (0.2–30.0) | 10.0 (0.2–146.0) | 4.3 (0.2–146.0) |
| Baseline PASI score, median (range) | 16.3 (10.5–43.4) | 16.2 (11.9–61) | NA | 16.2 (10.5–61)a |
| Baseline CDAI score, median (range) | NA | NA | 297 (109–518) | 297 (109–518)a |
Subjects who did not receive at least a single risankizumab dose (treated with either placebo or ustekinumab) were not included in the analyses
ADAs anti-drug antibodies, CDAI Crohn’s Disease Activity Index, NA not applicable, PASI Psoriasis Area and Severity Index
aDisease severity scores (PASI and CDAI) have been summarized for the relevant populations only