Baseline demographic and clinical characteristics: intent-to-treat population (N = 484). The “n” reflects the no. randomized patients who received at least 1 dose of study medication; actual no. patients available for each endpoint may vary slightly owing to missing data.
| Characteristics | Placebo, n = 159 | Apremilast | |
|---|---|---|---|
| 20 mg BID, n = 163 | 30 mg BID, n = 162 | ||
| Age, yrs, mean (SD) | 51.2 (11.0) | 50.9 (11.8) | 50.5 (11.2) |
| Female, n (%) | 85 (53.5) | 95 (58.3) | 95 (58.6) |
| Race, n (%) | |||
| White | 152 (95.6) | 151 (92.6) | 157 (96.9) |
| Asian | 3 (1.9) | 9 (5.5) | 1 (0.6) |
| Black | 2 (1.3) | 1 (0.6) | 1 (0.6) |
| Other | 2 (1.3)a | 2 (1.2) | 3 (1.9) |
| Region, n (%) | |||
| North America | 35 (22.0) | 38 (23.3) | 43 (26.5) |
| Europe | 106 (66.7) | 103 (63.2) | 101 (62.3) |
| Rest of world | 18 (11.3) | 22 (13.5) | 18 (11.1) |
| Weight, kg, mean (SD) | 84.9 (20.3) | 82.7 (21.9) | 82.7 (18.9) |
| BMI, kg/m2, mean (SD) | 29.5 (6.5) | 29.3 (6.6) | 29.2 (6.2) |
| Duration, yrs, mean (SD) | |||
| PsA | 7.8 (8.3) | 7.8 (8.6) | 6.8 (7.6) |
| Psoriasis | 17.8 (13.9) | 17.9 (14.1) | 18.7 (14.5) |
| PsA subtype, n (%) | |||
| Asymmetrical oligoarthritis | 49 (30.8) | 43 (26.4) | 42 (25.9) |
| Symmetric polyarthritis | 101 (63.5) | 109 (66.9) | 101 (62.3) |
| Predominant DIP joint involvement | 4 (2.5) | 7 (4.3) | 7 (4.3) |
| Predominant spondylitis | 1 (0.6) | 2 (1.2) | 5 (3.1) |
| Arthritis mutilans | 3 (1.9) | 2 (1.2) | 7 (4.3) |
| Missing | 1 (0.6) | 0 (0.0) | 0 (0.0) |
| SJC (0–76), mean (SD) | 9.2 (6.6) | 10.4 (7.8) | 10.3 (8.1) |
| TJC (0–78), mean (SD) | 18.0 (13.5) | 20.3 (16.6) | 21.8 (16.8) |
| HAQ-DI (0–3), mean (SD) | 1.2 (0.60) | 1.1 (0.62) | 1.2 (0.62) |
| DAS-28 (CRP), mean (SD) | 4.5 (1.1) | 4.6 (1.0) | 4.7 (1.0) |
| PASI score (0–72)b, mean (SD) | 8.6 (10.0) | 7.4 (6.5) | 7.8 (7.3) |
| Presence of enthesitis, n (%) | 104 (65.4) | 107 (65.6) | 101 (62.3) |
| Presence of dactylitis, n (%) | 66 (41.5) | 77 (47.2) | 73 (45.1) |
| Prior use of conventional DMARD only (biologic-naive), n (%) | 135 (84.9) | 135 (82.8) | 134 (82.7) |
| Prior use of biologics, n (%) | 23 (14.5) | 28 (17.2) | 23 (14.2) |
| Prior biologic therapeutic failures, n (%) | 8 (5.0) | 10 (6.1) | 7 (4.3) |
| Baseline DMARD use, n (%) | 113 (71.1) | 114 (69.9) | 113 (69.8) |
| MTX, mean dose 14.9 mg/week | 94 (59.1) | 94 (57.7) | 91 (56.2) |
| LEF, mean dose 18.1 mg/day | 17 (10.7) | 17 (10.4) | 21 (13.0) |
| SSZ, mean dose 1.8 g/day | 17 (10.7) | 18 (11.0) | 12 (7.4) |
| Baseline glucocorticoids, mean dosec: 6.29 mg/day, n (%) | 20 (12.6) | 36 (22.1) | 25 (15.4) |
↵a Including 1 patient with missing data.
↵b Examined among patients with baseline psoriasis BSA ≥ 3% and PASI score at baseline (placebo, n = 72; apremilast 20 mg BID, n = 80; apremilast 30 mg BID, n = 72).
↵c All converted to oral prednisone dose. BMI: body mass index; DAS28: 28-joint Disease Activity Score; DMARD: disease-modifying antirheumatic drug; HAQ-DI: Health Assessment Questionnaire–Disability Index; PASI: Psoriasis Area and Severity Index; PsA: psoriatic arthritis; SJC: swollen joint count; TJC: tender joint count; DIP: distal interphalangeal; MTX: methotrexate; LEF: leflunomide; SSZ: sulfasalazine.