Table 1.
Demographics and baseline characteristics
| Characteristics | RZB 150 mg N=224 |
PBO N=219 |
| Female, n (%) | 124 (55.4) | 120 (54.8) |
| Age (years), median (range) | 53 (23–84) | 52 (24 to 83) |
| Race, n (%) | ||
| White | 218 (97.3) | 210 (95.9) |
| Black or African–American | 2 (0.9) | 3 (1.4) |
| Asian | 2 (0.9) | 3 (1.4) |
| Other | 2 (0.9) | 3 (1.4) |
| Not Hispanic/Latino, n (%) | 182 (81.3) | 176 (80.4) |
| BMI (kg/m2), mean (SD) | 31.5 (8.0) | 31.2 (6.8) |
| PsA duration (years), mean (SD) | 8.2 (8.2) | 8.2 (8.3) |
| Swollen joint count,* mean (SD) | 13.0 (8.7) | 13.6 (9.0) |
| Tender joint count,† mean (SD) | 22.8 (14.9) | 22.3 (13.8) |
| Patient’s assessment of pain,‡ mean (SD) | 55.0 (23.5) | 57.0 (23.1) |
| PtGA of disease activity,‡ mean (SD) | 56.2 (21.8) | 56.2 (23.0) |
| PGA of disease activity,‡ mean (SD) | 63.0 (17.0) | 60.7 (16.4) |
| HAQ-DI, mean (SD) | 1.10 (0.62) | 1.13 (0.63) |
| hsCRP (mg/L),§ mean (SD) | 7.5 (10.9) | 8.2 (17.1) |
| Presence of psoriasis affecting ≥3% BSA, n (%) | 123 (54.9) | 119 (54.3) |
| BSA (%),¶ mean (SD) | 12.5 (15.4) | 11.7 (14.9) |
| PASI,¶ mean (SD) | 7.7 (6.7) | 8.4 (9.9) |
| MDA, n (%) | 5 (2.2) | 5 (2.3) |
| Presence of enthesitis,** n (%) | 147 (65.6) | 158 (72.1) |
| LEI,†† mean (SD) | 3.0 (1.5) | 3.0 (1.6) |
| Presence of dactylitis,‡‡ n (%) | 40 (17.9) | 57 (26.3) |
| LDI,§§ mean (SD) | 78.9 (98.4) | 109.8 (155.3) |
| SF-36 PCS score, mean (SD) | 35.6 (8.8) | 35.2 (9.1) |
| FACIT-Fatigue score, mean (SD) | 28.2 (11.5) | 27.7 (12.7) |
| Prior csDMARDs, n (%) | ||
| 0 | 12 (5.4) | 11 (5.0) |
| 1 | 88 (39.3) | 81 (37.0) |
| 2 | 60 (26.8) | 60 (27.4) |
| ≥3 | 64 (28.6) | 67 (30.6) |
| Any prior biologic, n (%) | 105 (46.9) | 101 (46.1) |
| Prior failed biologics, n (%) | ||
| 0 | 137 (61.2) | 132 (60.3) |
| 1 | 72 (32.1) | 64 (29.2) |
| ≥2 | 15 (6.7) | 23 (10.5) |
| Prior TNF antagonist, n (%) | 103 (46.0) | 100 (45.7) |
| Concomitant medication at baseline, n (%) | ||
| MTX¶¶ | 110 (49.1) | 99 (45.2) |
| csDMARD other than MTX*** | 31 (13.8) | 30 (13.7) |
| MTX and another csDMARD | 8 (3.6) | 10 (4.6) |
| Oral corticosteroids | 28 (12.5) | 22 (10.0) |
| NSAIDs | 141 (62.9) | 145 (66.2) |
*Based on 66 joints.
†Based on 68 joints.
‡Scored as millimetres on a 100 mm horizontal visual analogue scale.
§Reference range: 0–10 mg/dL.
¶Among patients with ≥3% BSA affected by psoriasis (RZB, n=23; PBO, n=119).
**LEI >0.
††Among patients with LEI >0 (RZB, n=147; PBO, n=158).
‡‡LDI >0.
§§Among patients with LDI>0 (RZB, n=40; PBO, n=57).
¶¶As monotherapy or in combination with another csDMARD.
***Sulfasalazine, leflunomide or apremilast, without MTX.
BMI, body mass index; BSA, body surface area; csDMARD, conventional synthetic disease-modifying antirheumatic drug; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy–Fatigue; HAQ-DI, Health Assessment Questionnaire–Disability Index; hsCRP, high-sensitivity C reactive protein; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; MDA, minimal disease activity; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drug; PASI, Psoriasis Area and Severity Index; PBO, placebo; SF-36 PCS, 36-Item Short Form Health Survey Physical Component Summary; PGA, physician’s global assessment; PsA, psoriatic arthritis; PtGA, patient’s global assessment; RZB, risankizumab; TNF, tumour necrosis factor.