Table 1.
Baseline demographic and disease characteristics
| Placebo | Ustekinumab | Total | ||
| 45 mg | 90 mg | |||
| Patients, n | 248 | 248 | 251 | 747 |
| Male | 128 (51.6) | 131 (52.8) | 143 (57.0) | 402 (53.8) |
| BMI (kg/m2) | 30.6±7.5 | 30.1±6.5 | 30.4±7.1 | 30.4±7.0 |
| Disease duration (years) | ||||
| PsA | 6.8±7.7 | 6.2±7.6 | 6.8±7.7 | 6.6±7.7 |
| <1 year | 61 (24.6) | 47 (19.0) | 40 (15.9) | 148 (19.8) |
| ≥1 to <3 years | 59 (23.8) | 72 (29.0) | 62 (24.7) | 193 (25.8) |
| ≥3 years | 128 (51.6) | 129 (52.0) | 149 (59.4) | 406 (54.4) |
| Psoriasis | 15.6±12.9 | 14.5±12.6 | 15.1±12.6 | 15.1±12.7 |
| Patients with psoriasis involving ≥3% BSA, n | 176 | 181 | 189 | 546 |
| PASI | 12.0±10.2 | 11.9±12.1 | 10.7 (8.7) | 11.5±10.4 |
| DLQI | 11.9±7.6 | 11.2±7.2 | 10.6±7.1 | 11.2±7.3 |
| Swollen joint count (0–66) | 14.7±9.9 | 12.6±7.6 | 12.8±8.6 | 13.4±8.8 |
| Tender joint count (0–68) | 24.4±14.6 | 22.5±14.1 | 22.8±13.8 | 23.2±14.2 |
| CRP (mg/L) | 15.6±18.4 | 18.1±22.1 | 17.4±18.7 | 17.1±19.8 |
| HAQ-DI | 1.24±0.67 | 1.22±0.62 | 1.21±0.62 | 1.22±0.64 |
| DAS28-CRP | 5.2±1.1 | 5.2±1.0 | 5.2±1.0 | 5.2±1.0 |
| Patients with dactylitis in ≥1 digit | 113 (45.6) | 120 (48.4) | 113 (45.0) | 346 (46.3) |
| Dactylitis score | 8.3±10.0 | 7.8±9.7 | 7.9±8.6 | 8.0±9.4 |
| Patients with enthesitis | 176 (71.0) | 167 (67.3) | 184 (73.3) | 527 (70.5) |
| Enthesitis score | 5.2±3.8 | 5.1±3.6 | 5.7±3.9 | 5.3±3.8 |
| SF-36 PCS score | 31.3±8.6 | 31.0±8.4 | 31.4±8.0 | 31.2±8.3 |
| SF-36 MCS score | 42.7±11.2 | 42.7±11.2 | 43.4±11.5 | 42.9±11.3 |
| Concomitant MTX use at baseline | 121 (48.8) | 127 (51.2) | 129 (51.4) | 377 (50.5) |
| MTX-naïve | 56 (22.6) | 58 (23.4) | 65 (25.9) | 179 (24.0) |
| csDMARD-naïve | 45 (18.1) | 48 (19.4) | 53 (21.1) | 146 (19.5) |
Data are presented as n (%) or mean±SD unless otherwise noted.
BMI, body mass index; BSA, body surface area; CRP, C reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAS28-CRP, 28-joint count disease activity score using C reactive protein; DLQI, Dermatology Life Quality Index; HAQ-DI, Health Assessment Questionnaire–Disability Index; MTX, methotrexate; PASI, psoriasis area and severity index; SF-36 PCS/MCS, 36-item Short-Form Health Survey physical/mental component summary; PsA, psoriatic arthritis.