Table 1.
Demographics and characteristics at baseline
| Characteristic | RZB 150 mg N=483 |
Placebo N=481 |
| Women, n (%) | 231 (47.8) | 247 (51.4) |
| Age (years), median (range) | 52 (20–85) | 52 (22–79) |
| Race, n (%) | ||
| White | 454 (94.0) | 451 (93.8) |
| Black/African American | 4 (0.8) | 2 (0.4) |
| Asian | 13 (2.7) | 22 (4.6) |
| Native Hawaiian/Pacific Islander | 3 (0.6) | 1 (0.2) |
| American Indian/Alaskan Native | 1 (0.2) | 0 |
| Multiple | 8 (1.7) | 5 (1.0) |
| Not Hispanic/Latino, n (%) | 390 (80.7) | 389 (80.9) |
| BMI, kg/m2, mean (SD) | 30.7 (6.4) | 30.3 (6.2) |
| PsA duration, years, mean (SD) | 7.1 (7.0) | 7.1 (7.7) |
| Swollen joint count,* mean (SD) | 12.1 (7.8) | 12.2 (8.0) |
| Tender joint count,† mean (SD) | 20.8 (14.1) | 20.5 (12.8) |
| Patient’s assessment of pain,‡ mean (SD) | 57.1 (22.6) | 57.1 (22.6) |
| PtGA of disease activity,‡ mean (SD) | 57.9 (21.8) | 57.4 (22.1) |
| PGA of disease activity,‡ mean (SD) | 61.3 (17.6) | 62.4 (17.0) |
| HAQ-DI, mean (SD) | 1.15 (0.66) | 1.17 (0.65) |
| hsCRP, mg/L, mean (SD) | 11.9 (15.9) | 11.3 (14.1) |
| PsA-mTSS, mean (SD) | 13.0 (29.9) | 13.5 (29.0) |
| Presence of psoriasis affecting ≥3% BSA, n (%) | 273 (56.5) | 272 (56.5) |
| BSA,§ %, mean (SD) | 16.8 (19.7) | 16.5 (20.8) |
| PASI,§ mean (SD) | 10.9 (10.1) | 10.0 (10.4) |
| Presence of nail psoriasis, n (%) | 309 (64.0) | 338 (70.6) |
| mNAPSI,¶ mean (SD) | 18.1 (16.4) | 16.6 (16.0) |
| PGA-F,¶ mean (SD) | 2.1 (1.0) | 2.0 (1.0) |
| MDA, n (%) | 2 (0.4) | 6 (1.2) |
| Presence of enthesitis,** n (%) | 297 (61.5) | 290 (60.3) |
| LEI,†† mean (SD) | 2.7 (1.5) | 2.6 (1.5) |
| Presence of dactylitis,‡‡ n (%) | 148 (30.6) | 147 (30.6) |
| LDI,§§ mean (SD) | 98.6 (120.4) | 92.5 (125.5) |
| SF-36 PCS, mean (SD) | 35.2 (8.1) | 35.2 (7.7) |
| FACIT-Fatigue, mean (SD) | 29.4 (11.3) | 29.3 (11.2) |
| Prior csDMARDs,¶¶ n (%) | ||
| 0 | 2 (0.4) | 2 (0.4) |
| 1 | 338 (70.0) | 311 (64.7) |
| 2 | 105 (21.7) | 136 (28.3) |
| ≥3 | 38 (7.9) | 32 (6.7) |
| Concomitant medication use, n (%) | ||
| MTX*** | 314 (65.0) | 315 (65.5) |
| csDMARD other than MTX††† | 52 (10.8) | 49 (10.2) |
| MTX and another csDMARD | 20 (4.1) | 29 (6.0) |
| Oral corticosteroids | 101 (20.9) | 87 (18.1) |
| NSAID | 296 (61.3) | 314 (65.3) |
*Based on 66 joints.
†Based on 68 joints.
‡Scored as millimetres on a 100 mm horizontal Visual Analogue Scale.
§Among patients with ≥3% BSA affected by psoriasis (RZB, n=273; PBO, n=271).
¶Among patients with nail psoriasis (RZB, n=309; PBO, n=338).
**LEI >0.
††Among patients with LEI >0.
‡‡LDI >0.
§§Among patients with LDI >0.
¶¶Includes 32 patients who reported prior treatment with apremilast (RZB, n=11 (2.3%); PBO, n=21 (4.4%)) and five patients who reported prior treatment with tofacitinib (RZB, n=2 (0.4%); PBO, n=3 (0.6%)).
***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 for PsA; mNAPSI, modified Nail Psoriasis Severity Index; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drug; PASI, Psoriasis Area and Severity Index; PBO, placebo; PGA, physician global assessment; PGA-F, Physician’s Global Assessment of Fingernail Psoriasis; PsA, psoriatic arthritis; PsA-mTSS, PsA-modified Total Sharp Score; PtGA, patient’s global assessment; RZB, risankizumab; SF-36 PCS, 36-Item Short-Form Health Survey Physical Component Summary.