Table 1.
Baseline patient characteristics (full analysis set)
| Placebo n=109 | Apremilast 30 mg twice daily n=110 |
|
| Age, mean (SD), years | 48.0 (13.8) | 50.7 (12.2) |
| Female, n (%) | 65 (59.6) | 58 (52.7) |
| White, n (%) | 105 (96.3) | 109 (99.1) |
| Region, n (%) | ||
| North America | 42 (38.5) | 42 (38.2) |
| Europe | 38 (34.9) | 47 (42.7) |
| Rest of world | 29 (26.6) | 21 (19.1) |
| Weight, mean (SD), kg | 90.1 (21.1) | 92.6 (24.0) |
| Body mass index, mean (SD), kg/m2 | 31.8 (7.8) | 32.0 (7.9) |
| PsA duration, mean (SD), years | 3.6 (5.5) | 4.0 (4.5) |
| SJC (0–76), mean (SD) | 10.0 (5.9) | 9.0 (4.9) |
| TJC (0–78), mean (SD) | 18.4 (14.2) | 17.2 (12.7) |
| High-sensitivity CRP, mg/dL, mean (SD) | 1.25 (1.6) | 1.44 (1.6) |
| Erythrocyte sedimentation rate, mm/h | 30.3 (17.5) | 33.1 (19.0) |
| Enthesitis*, n (%) | 51 (46.8) | 56 (50.9) |
| GEI score (0–6)†, mean (SD) | 2.4 (1.6) | 2.3 (1.3) |
| HAQ-DI sore (0–3), mean (SD) | 1.20 (0.59) | 1.25 (0.61) |
| Use of PsA-related medications | ||
| Prior use of csDMARDs, n (%) | 78 (71.6) | 74 (67.3) |
| Prior use of methotrexate, n (%) | 66 (60.6) | 61 (55.5) |
| Baseline corticosteroid use‡ (mean dose, 4.4 mg/day), n (%) | 14 (12.8) | 13 (11.8) |
| Baseline non-steroidal anti-inflammatory drug use, n (%) | 74 (67.9) | 76 (69.1) |
Note: the n reflects the number of patients who were randomised; actual number of patients available for each parameter may vary.
*Pre-existing enthesopathy is defined as having a baseline GEI score greater than 0.
†Provided for patients with pre-existing enthesopathy.
‡All converted to oral prednisone dose.
CRP, C reactive protein; csDMARDs, conventional synthetic disease-modifying antirheumatic drugs; GEI, Gladman Enthesitis Index; HAQ-DI, Health Assessment Questionnaire-Disability Index; PsA, psoriatic arthritis; SJC, swollen joint count; TJC, tender joint count.