Baseline patient demographics and disease characteristics among all randomised patients
| Placebo | UST 45 mg | UST 90 mg | |
|---|---|---|---|
| All patients (N) | 104 | 103 | 105 |
| Women | 53 (51.0) | 55 (53.4) | 56 (53.3) |
| Age (years) | 48.0 (38.5 to 56.0) | 49.0 (40.0 to 56.0) | 48.0 (41.0 to 57.0) |
| Body mass index (kg/m2) | 30.5 (26.8 to 35.7) | 30.2 (25.5 to 36.9) | 30.3 (25.3 to 37.1) |
| Duration of disease (years) | |||
| Psoriatic arthritis | 5.5 (2.3 to 12.2) | 5.3 (2.3 to 12.2) | 4.5 (1.7 to 10.3) |
| Psoriasis | 11.4 (6.0 to 22.0) | 13.3 (5.0 to 24.4) | 11.3 (4.5 to 21.4) |
| Swollen joint count (0–66) | 11.0 (7.0 to 18.0) | 12.0 (8.0 to 19.0) | 11.0 (7.0 to 17.0) |
| Tender joint count (0–68) | 21.0 (11.0 to 30.0) | 22.0 (15.0 to 33.0) | 22.0 (14.0 to 36.0) |
| CRP (mg/L) | 8.5 (4.6 to 22.0) | 13.0 (4.5 to 36.3) | 10.1 (4.8 to 19.8) |
| HAQ-DI score (0–3) | 1.3 (0.8 to 1.8) | 1.4 (0.8 to 1.9) | 1.3 (0.8 to 1.9) |
| DAS28-CRP score | 5.2 (4.4 to 5.9) | 5.6 (4.9 to 6.3) | 5.3 (4.7 to 6.0) |
| Patients with dactylitis in ≥1 digit | 38 (36.5) | 48 (46.6) | 41 (39.0) |
| Dactylitis score (1–60) | 7.0 (3.0 to 14.0) | 5.0 (2.0 to 13.0) | 7.0 (2.0 to 15.0) |
| Patients with enthesitis | 73 (70.2) | 72 (69.9) | 76 (72.4) |
| Enthesitis score (1–15) | 4.0 (2.0 to 8.0) | 6.0 (3.0 to 9.0) | 5.0 (3.0 to 8.0) |
| Patients with spondylitis/peripheral joint involvement | 22 (21.2) | 26 (25.2) | 22 (21.0) |
| BASDAI score (1–10) | 6.6 (5.8 to 7.8) | 7.6 (5.7 to 8.2) | 7.1 (5.8 to 7.9) |
| Patients with ≥3% BSA involved with psoriasis | 80 (76.9) | 80 (77.7) | 81 (77.1) |
| PASI score (0–72) | 7.9 (4.5 to 16.0) | 8.6 (4.5 to 18.3) | 8.8 (4.5 to 18.0) |
| DLQI score (0–30) | 11.0 (5.0 to 16.5) | 11.0 (6.0 to 18.0) | 10.0 (6.0 to 18.0) |
| FACIT-Fatigue score (0–52) | 28.0 (17.0 to 34.5) | 26.0 (17.0 to 33.0) | 24.5 (17.0 to 34.5) |
| SF-36 summary scores (n) | 104 | 102 | 104 |
| Mental component (0–100) | 41.8 (31.6 to 53.5) | 43.7 (33.0 to 54.6) | 41.4 (33.8 to 54.9) |
| Physical component (0–100) | 29.4 (23.3 to 36.2) | 28.0 (22.6 to 34.0) | 28.2 (21.8 to 33.6) |
| Current medication use | |||
| Methotrexate | 49 (47.1) | 54 (52.4) | 52 (49.5) |
| Dose (mg/week), mean/median | 17.4/17.5 | 17.2/15.0 | 15.9/15.0 |
| Oral corticosteroids | 13 (12.5) | 21 (20.4) | 16 (15.2) |
| Dose (mg/day), mean/median | 8.0/7.5 | 7.0/5.0 | 7.5/7.5 |
| NSAIDs | 77 (74.0) | 72 (69.9) | 70 (66.7) |
Data are reported as n (%) or median (IQR) unless noted otherwise.
BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BSA, body surface area; CRP, C-reactive protein; DAS28-CRP, 28-joint disease activity score employing CRP; DLQI, Dermatology Life Quality Index; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Health Assessment Questionnaire-Disability Index; NSAIDs, non-steroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; pts, patients; SF-36, 36-item short-form healthy survey; UST, ustekinumab.