Table 2.
Demographics and baseline characteristics of subjects who received risankizumab in each study
| Characteristic | Study | All subjects | ||||||
|---|---|---|---|---|---|---|---|---|
| M16-513 | 1311.1 | 1311.2 | UltIMMa-1 | UltIMMa-2 | IMMvent | IMMhance | ||
| n | 67 | 31 | 126 | 401 | 394 | 392 | 500 | 1911a |
| Country [n (%)] | ||||||||
| USA (USA, Canada) | 20 (65) | 81 (64) | 239 (60) | 291 (74) | 202 (52) | 354 (71) | 1187 (62) | |
| Taiwan | 37 (9) | 37 (2) | ||||||
| Korea | 12 (18) | 43 (11) | 51 (10) | 106 (6) | ||||
| Japan | 36 (54) | 39 (10) | 13 (3) | 88 (5) | ||||
| Europe | 11 (35) | 45 (36) | 52 (13) | 86 (22) | 144 (37) | 52 (10) | 390 (20) | |
| China | 19 (28)b | 19 (1) | ||||||
| Rest of world | 28 (7) | 17 (4) | 9 (2) | 30 (6) | 84 (4) | |||
| Age (years) | ||||||||
| Mean (SD) | 28.5 (6.47) | 42.4 (10.5) | 46.0 (13.9) | 48.4 (13.4) | 46.4 (13.6) | 46.1 (13.8) | 49.2 (13.3) | 46.8 (13.8) |
| Median | 27 | 45 | 47 | 48 | 47 | 47 | 51 | 47 |
| Min–max | 21–45 | 24–61 | 20–72 | 21–85 | 19–76 | 18–78 | 19–79 | 18–85 |
| Body weight (kg) | ||||||||
| Mean (SD) | 65.8 (10.1) | 88.7 (18.9) | 89.8 (19.0) | 88.1 (22.3) | 92.2 (21.2) | 90.2 (24.3) | 91.8 (22.9) | 89.7 (22.6) |
| Median | 64.2 | 89.0 | 89.0 | 84.0 | 90.3 | 86.8 | 89.4 | 87.0 |
| Min–max | 50.6–94.4 | 47.0–121 | 49.2–138 | 45.0–161 | 46.0–170 | 42.6–190 | 47.0–193 | 42.6–193 |
| Body mass index (kg/m2) | ||||||||
| Mean (SD) | 21.9 (2.37) | 29.6 (5.79) | 30.3 (5.61) | 29.8 (6.81) | 31.1 (6.75) | 30.5 (8.04) | 31.2 (7.11) | 30.3 (7.16) |
| Median | 21.4 | 29.1 | 29.9 | 28.6 | 30.4 | 29.3 | 30.1 | 29.4 |
| Min–max | 18.5–29.1 | 20.9–39.6 | 18.5–39.9 | 16.6–59.8 | 15.0–57.4 | 16.4–92.7 | 17.3–67.0 | 15.0–92.7 |
| Sex [n (%)] | ||||||||
| Male | 67 (100) | 25 (81) | 82 (65) | 286 (71) | 270 (69) | 271 (69) | 349 (70) | 1350 (71) |
| Female | 6 (19) | 44 (35) | 115 (29) | 124 (31) | 121 (31) | 151 (30) | 561 (29) | |
| Race [n (%)] | ||||||||
| White and others (including all categories except Asians) | 12 (18) | 31 (100) | 124 (98) | 289 (72) | 362 (92) | 338 (86) | 422 (84) | 1578 (83) |
| Asian | 55 (82) | 2 (2) | 112 (28) | 32 (8) | 54 (14) | 78 (16) | 333 (17) | |
| hs-CRP (mg/L) | ||||||||
| Mean (SD) | 0.5 (0.5) | 4.8 (6.6) | 4.4 (4.8) | 6.0 (9.7) | 5.7 (7.7) | 6.7 (12.2) | 6.5 (11.6) | 5.9 (10.0) |
| Median | 0.4 | 3.3 | 2.6 | 2.9 | 3.1 | 2.7 | 3.3 | 2.8 |
| Min–max | 0.1–2.3 | 0.3–34.4 | 0.2–30.0 | 0.2–78.8 | 0.2–79.7 | 0.2–103 | 0.2–131 | 0.1–131 |
| Baseline PASI score | ||||||||
| Mean (SD) | 18.5 (7.4) | 18.7 (7.4) | 20.6 (7.4) | 20.0 (7.6) | 20.0 (7.7) | 20.0 (7.9) | 20.0 (7.6)c | |
| Median | 16.3 | 16.2 | 18.4 | 17.8 | 17.7 | 17.4 | 17.8c | |
| Min–max | 10.5–43.4 | 11.9–61.0 | 12.0–54.7 | 12.0–60.3 | 12.0–50.4 | 12.0–63.4 | 10.5–63.4c | |
| Total bilirubin (µmol/L) | ||||||||
| Mean (SD) | 15.0 (5.0) | 9.0 (6.0) | 8.6 (4.7) | 9.6 (5.5) | 8.6 (5.2) | 8.9 (4.6) | 9.0 (5.3) | 9.2 (5.2) |
| Median | 13.7 | 7.0 | 6.8 | 8.6 | 7.0 | 8.0 | 8.0 | 8.0 |
| Min–max | 6.8–25.7 | 3.4–27.4 | 3.4–29.1 | 3.4–45.0 | 3.0–57.0 | 3.4–39.0 | 3.0–55.0 | 3.0–57.0 |
| Serum albumin (g/L) | ||||||||
| Mean (SD) | 45.7 (2.38) | NA | 42.2 (3.32) | 44.6 (2.94) | 44.0 (2.92) | 44.7 (2.96) | 44.2 (2.76) | 44.3 (2.97)d |
| Median | 46.0 | NA | 42.0 | 45.0 | 44.0 | 45.0 | 44.0 | 44.0d |
| Min–max | 40.0–51.0 | NA | 34.0–51.0 | 34.0–58.0 | 35.0–52.0 | 35.0–53.0 | 34.0–51.0 | 34.0–58.0d |
| Serum creatinine (µmol/L) | ||||||||
| Mean (SD) | 79.5 (11.4) | 79.3 (14.9) | 78.5 (14.8) | 76.6 (16.3) | 77.7 (17.0) | 75.1 (15.2) | 76.4 (17.1) | 76.8 (16.2) |
| Median | 79.6 | 79.6 | 79.6 | 76.0 | 79.6 | 74.0 | 73.5 | 76.0 |
| Min–max | 55.7–105 | 53.1–106 | 53.1–124 | 35.4–133 | 35.4–159 | 35.4–128 | 35.4–203 | 35.4–203 |
| Creatinine clearancee (mL/min) | ||||||||
| Mean (SD) | 115 (18.3) | 134 (40.3) | 129 (39.2) | 129 (47.6) | 135 (45.4) | 137 (52.7) | 133 (47.0) | 132 (46.9) |
| Median | 114 | 132 | 129 | 118 | 127 | 127 | 125 | 124 |
| Min–max | 76.0–163 | 57.3–227 | 44.5–327 | 33.5–388 | 49.2–389 | 33.1–404 | 37.2–360 | 33.1–404 |
| Aspartate aminotransferase (U/L) | ||||||||
| Mean (SD) | 20.8 (5.5) | 26.7 (12.4) | 25.8 (12.8) | 25.8 (12.7) | 24.2 (12.4) | 25.8 (20.8) | 24.6 (11.9) | 25.0 (14.4) |
| Median | 20.0 | 23.0 | 23.0 | 22.0 | 21.0 | 22.0 | 22.0 | 22.0 |
| Min–max | 12.0–37.0 | 14.0–65.0 | 11.0–88.0 | 10.0–121 | 9.0–135 | 10.0–236 | 8.0–155 | 8.0–236 |
| Alanine transaminase (U/L) | ||||||||
| Mean (SD) | 20.6 (11.6) | 30.2 (17.0) | 29.2 (20.0) | 29.3 (20.0) | 27.8 (20.3) | 30.3 (25.2) | 27.5 (15.6) | 28.4 (20.0) |
| Median | 16.0 | 28.0 | 24.0 | 23.0 | 23.0 | 23.5 | 24.0 | 23.0 |
| Min–max | 7.0–59.0 | 10.0–72.0 | 6.0–115 | 6.0–128 | 7.0–239 | 6.0–229 | 7.0–112 | 6.0–239 |
| Treatment-emergent ADA status (yes) [n (%)] | 4 (6) | 3 (10) | 18 (14) | 90 (22) | 75 (19) | 99 (25) | 138 (27) | 427 (22) |
| ADA titer ≥ 128 (nf) | – | 3 | 5 | 2 | 8 | 10 | 4 | 32 |
| NAb treatment-emergent status (yes) [n (%)] | NA | NA | 4 (3) | 52 (13) | 41 (10) | 56 (14) | 85 (17) | 238 (12) |
ADA anti-drug antibody, hs-CRP high-sensitivity C-reactive protein, Max maximum, Min minimum, NA data not collected, NAb neutralizing antibody, PASI Psoriasis Area Severity Index, SD standard deviation
aConcentration data from 12 subjects were excluded as described in Sect. 3, leaving a total of 1899 subjects for the population pharmacokinetic analyses
bSubjects were enrolled in Korea
cn = 1844
dn = 1880
eCalculated based on the Cockcroft-Gault formula: creatinine clearance (mL/min) = [140 − AGE (y)] × body weight (kg)/[71.87 × serum creatinine (mg/dL)] × 0.84557 (if female)
fSummary calculated only among those subjects with an ADA titer ≥ 128. One subject in Study 1311.1 had a baseline ADA titer value of 128 and a maximum ADA titer value of 256, and one subject in Study UltIMMa-2 had a baseline and maximum ADA titer of 128; these subjects are included in the table, but they are not treatment-emergent ADA positive