Table 1. Patient Baseline Characteristics.
| Characteristic | Risankizumab (n = 598) | Ustekinumab (n = 199) | Placebo (n = 200) |
|---|---|---|---|
| Demographics | |||
| Women, No. (%) | 183 (30.6) | 63 (31.7) | 54 (27.0) |
| Age, mean (SD), y | 47.2 (13.6) | 47.5 (14.1) | 47.8 (13.5) |
| Ethnicity | |||
| White, No. (%) | 455 (76.1) | 165 (82.9) | 158 (79.0) |
| Black or African American, No. (%) | 20 (3.3) | 3 (1.5) | 3 (1.5) |
| Asian, No. (%) | 111 (18.6) | 26 (13.1) | 35 (17.5) |
| Other, No. (%) | 12 (2.0) | 5 (2.5) | 4 (2.0) |
| Hispanic, No. (%) | 67 (11.2) | 24 (12.1) | 31 (15.5) |
| Weight, mean (SD), kg | 90.0 (22.4) | 90.4 (22.2) | 90.5 (20.1) |
| Weight ≤100 kg, No. (%) | 429 (71.7) | 143 (71.9) | 143 (71.5) |
| Weight >100 kg, No. (%) | 169 (28.3) | 56 (28.1) | 57 (28.5) |
| BMI,a mean (SD) | 30.5 (7.0) | 30.4 (6.8) | 30.2 (6.2) |
| Disease characteristics | |||
| PASI, mean (SD) | 20.6 (7.7) | 19.2 (6.4) | 19.7 (7.0) |
| BSA involvement (%), mean (SD) | 26.2 (15.6) | 23.0 (13.6) | 26.0 (16.6) |
| Psoriasis duration since diagnosis, mean (SD), y | 18.1 (12.6) | 17.3 (11.2) | 19.1 (13.3) |
| C-reactive protein, mg/L, mean (SD) | 5.7 (8.5) | 5.3 (8.5) | 5.9 (9.5) |
| sPGA score, mean (SD) | 3.2 (0.4) | 3.2 (0.4) | 3.2 (0.4) |
| sPGA moderate, No. (%) | 484 (80.9) | 166 (83.4) | 163 (81.5) |
| sPGA severe, No. (%) | 114 (19.1) | 33 (16.6) | 37 (18.5) |
| Any previous biologic therapy, No. (%) | 222 (37.1) | 73 (36.7) | 82 (41.0) |
| TNF inhibitor, No. (%) | 134 (22.4) | 43 (21.6) | 48 (24.0) |
| Non-TNF inhibitor, No. (%) | 129 (21.6) | 48 (24.1) | 49 (24.5) |
| Patient-reported outcomes, mean (SD) | |||
| PSS total score | 8.1 (3.8) | 8.5 (3.7) | 8.1 (3.5) |
| PSS pain | 1.6 (1.2) | 1.6 (1.2) | 1.6 (1.1) |
| PSS redness | 2.4 (1.0) | 2.6 (1.0) | 2.5 (0.9) |
| PSS itchiness | 2.4 (1.1) | 2.5 (1.1) | 2.3 (1.0) |
| PSS burning | 1.7 (1.2) | 1.7 (1.2) | 1.7 (1.2) |
| DLQI total score | 13.3 (7.2) | 12.7 (7.0) | 12.6 (6.5) |
| EQ-5D-5L | 0.8 (0.2) | 0.8 (0.2) | 0.8 (0.2) |
| HADS anxiety scale | 7.2 (4.1) | 7.3 (4.3) | 6.9 (3.9) |
| Symptomatic anxiety (>8), No. (%) | 244 (40.8) | 83 (41.7) | 77 (38.5) |
| HADS depression scale | 5.3 (3.8) | 5.3 (4.0) | 5.3 (3.9) |
| Symptomatic depression (>8), No. (%) | 150 (25.1) | 56 (28.1) | 54 (27.0) |
| Comorbidities, No.(%) | |||
| Angina pectoris | 5 (0.8) | 1 (0.5) | 4 (2.0) |
| Deep vein thrombosis | 6 (1.0) | 2 (1.0) | 1 (0.5) |
| Diabetes mellitus | 87 (14.6) | 28 (14.1) | 27 (13.5) |
| Hyperlipidemia | 139 (23.4) | 53 (26.8) | 50 (25.3) |
| Hypertension | 182 (30.5) | 72 (36.5) | 49 (24.5) |
| Myocardial infarction | 14 (2.3) | 9 (4.5) | 2 (1.0) |
| Obesity | 298 (49.8) | 93 (46.7) | 97 (48.5) |
| Psoriatic arthritis (diagnosed or suspected) | 159 (26.6) | 50 (25.1) | 68 (34.0) |
| Stroke | 7 (1.2) | 1 (0.5) | 1 (0.5) |
| Transient ischemic attack | 0 | 2 (1.0) | 1 (0.5) |
Abbreviations: BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; EQ-5D-5L, 5-level EuroQoL-5D; HADS, Hospital Anxiety and Depression Scale; PASI, Psoriasis Area and Severity Index; PSS, Psoriasis Symptom Scale; sPGA, static Physician's Global Assessment; TNF, tumor necrosis factor.
a
Calculated as weight in kilograms divided by height in meters squared.