Table 1.
Baseline demographic and clinical characteristics: intent-to-treat population (N=505)*
| Apremilast | |||
|---|---|---|---|
| Placebo n=169 |
20 mg twice daily n=169 |
30 mg twice daily n=167 |
|
| Age, mean (SD), years | 49.5 (11.6) | 49.6 (12.1) | 49.9 (11.4) |
| Female, n (%) | 91 (54) | 90 (53) | 88 (53) |
| Race, n (%) | |||
| White | 158 (94) | 161 (95) | 163 (98) |
| Asian | 7 (4) | 6 (4) | 2 (1) |
| Black | 2 (1) | 0 (0) | 0 (0) |
| Other | 2 (1) | 2 (1) | 2 (1) |
| Region, n (%) | |||
| North America | 48 (28) | 58 (34) | 58 (35) |
| Europe | 75 (44) | 79 (47) | 78 (47) |
| Rest of the world | 46 (27) | 32 (19) | 31 (19) |
| Weight, mean (SD), kg | 84.5 (20.0) | 86.4 (20.1) | 83.7 (20.1) |
| BMI, mean (SD), kg/m2 | 29.5 (6.4) | 30.1 (6.3) | 29.2 (6.4) |
| Duration, mean (SD), years | |||
| PsA | 6.8 (6.5) | 7.7 (7.7) | 7.5 (7.6) |
| Psoriasis | 17.8 (13.3) | 18.3 (14.4) | 17.1 (12.1) |
| Prior use of conventional DMARDs only (biologic-naïve), n (%) | 121 (72) | 118 (70) | 124 (74) |
| Prior use of biologics, n (%) | 48 (28) | 50 (30) | 43 (26) |
| Prior biologic therapeutic failures, n (%) | 12 (7) | 18 (11) | 14 (8) |
| Baseline DMARD use, n (%) | 101 (60) | 104 (62) | 101 (61) |
| MTX (mean dose: 14.75 mg/wk) | 91 (54) | 88 (52) | 83 (50) |
| Leflunomide (mean dose: 19.20 mg/day) | 5 (3) | 12 (7) | 8 (5) |
| Sulfasalazine (mean dose: 1.69 g/day) | 10 (6) | 10 (6) | 14 (8) |
| Baseline corticosteroids† (mean dose: 6.52 mg/day), n (%) | 16 (10) | 34 (20) | 23 (14) |
| SJC (0–76), mean (SD) | 11.1 (7.9) | 11.4 (9.1) | 11.6 (8.7) |
| TJC (0–78), mean (SD) | 18.3 (14.9) | 20.8 (16.8) | 20.9 (14.4) |
| HAQ-DI (0–3), mean (SD) | 1.2 (0.63) | 1.1 (0.65) | 1.2 (0.67) |
| CRP (normal range: 0–0.5), mg/dL, mean (SD) | 1.00 (1.35) | 0.97 (1.51) | 1.15 (1.88) |
| Patient's global assessment of disease activity (0–100 mm VAS), mean (SD) | 56.1 (21.0) | 54.3 (20.9) | 56.5 (24.2) |
| Physician's global assessment of disease activity (0–100 mm VAS), mean (SD) | 52.8 (18.8) | 55.2 (18.8) | 56.1 (18.2) |
| DAS-28 (CRP), mean (SD) | 4.5 (1.1) | 4.6 (1.1) | 4.6 (1.0) |
| DAS-28 (CRP) <2.6, n (%) | 6 (4) | 4 (2) | 1 (0.6) |
| BSA ≥3%, n (%)‡ | 94 (56) | 93 (55) | 92 (55) |
| PASI score (0–72)‡, mean (SD) | 7.6 (7.2) | 7.6 (5.2) | 7.9 (6.3) |
| Presence of enthesitis, n (%) | 109 (65) | 97 (57) | 112 (67) |
| MASES (0–13), mean (SD) | 4.4 (3.3) | 4.4 (3.2) | 4.4 (3.2) |
| Presence of dactylitis, n (%) | 71 (42) | 71 (42) | 80 (48) |
| Dactylitis count (0–20), mean (SD) | 3.9 (4.0) | 3.7 (3.6) | 4.1 (4.3) |
*The n reflects the number of randomised patients; actual number of patients available for some parameters may vary slightly due to missing data.
†All converted to oral prednisone dose.
‡Examined among patients with BSA ≥3% at baseline and having data at baseline (placebo: n=86; apremilast 20 mg twice daily: n=87; apremilast 30 mg twice daily: n=89).
BMI, body mass index; BSA, body surface area; CRP, C reactive protein; DAS-28, 28-joint disease activity score; DMARDs, disease-modifying antirheumatic drugs; HAQ-DI, Health Assessment Questionnaire-Disability Index; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; MTX, methotrexate; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; SJC, swollen joint count; TJC, tender joint count; VAS, visual analogue scale.