Baseline demographics and clinical characteristics: intent-to-treat population (N=504*)
| Apremilast | |||
|---|---|---|---|
| Placebo n=168 | 20 mg BID n=168 | 30 mg BID n=168 | |
| Age, mean (SD), years | 51.1 (12.1) | 48.7 (11.0) | 51.4 (11.7) |
| Age ≥65 years, n | 19 (11.3%) | 11 (6.5%) | 22 (13.1%) |
| Female, n | 80 (47.6%) | 83 (49.4%) | 92 (54.8%) |
| Race, n | |||
| White | 153 (91.1%) | 150 (89.3%) | 152 (90.5%) |
| Asian | 8 (4.8%) | 8 (4.8%) | 8 (4.8%) |
| Black | 0 (0.0%) | 2 (1.2%) | 0 (0.0%) |
| Other | 7 (4.2%) | 8 (4.8%) | 8 (4.8%) |
| Region, n | |||
| North America | 81 (48.2%) | 73 (43.5%) | 69 (41.1%) |
| Europe | 39 (23.2%) | 41 (24.4%) | 42 (25.0%) |
| Rest of world | 48 (28.6%) | 54 (32.1%) | 57 (33.9%) |
| Weight, mean (SD), kg | 89.8 (22.4) | 88.8 (21.1) | 87.1 (19.6) |
| Body mass index, mean (SD), kg/m2 | 31.1 (6.6) | 30.9 (7.3) | 30.6 (5.9) |
| Duration of psoriatic arthritis, mean (SD), years | 7.3 (7.1) | 7.2 (6.8) | 8.1 (8.1) |
| Swollen joint count (0–76), mean (SD) | 12.8 (8.8) | 12.5 (9.5) | 12.8 (7.8) |
| Tender joint count (0–78), mean (SD) | 23.3 (15.2) | 22.2 (15.9) | 23.1 (14.5) |
| HAQ-DI (0–3), mean (SD) | 1.2 (0.6) | 1.2 (0.6) | 1.2 (0.6) |
| Patient Global Assessment (0–100 mm VAS), mean (SD) | 58.8 (22.3) | 55.3 (23.7) | 55.9 (21.5) |
| Physician Global Assessment (0–100 mm VAS), mean (SD) | 55.2 (20.3) | 54.1 (21.8) | 55.7 (19.2) |
| CRP (mg/dL, normal range <0.5), mean (SD) | 1.1 (1.436) | 0.90 (1.409) | 0.84 (1.024) |
| Patient assessment of pain (0–100 mm VAS), mean (SD) | 61.2 (20.2) | 54.9 (22.9) | 57.9 (20.2) |
| SF-36v2 PF score, mean (SD) | 33.8 (10.6) | 35.1 (10.7) | 33.0 (10.2) |
| DAS-28 (CRP), mean (SD) | 4.9 (1.0) | 4.8 (1.1) | 4.9 (1.0) |
| CDAI (0–76), mean (SD) | 29.7 (12.0) | 28.4 (13.1) | 29.4 (11.5) |
| Duration of psoriasis, mean (SD), years | 15.7 (13.0) | 15.5 (11.9) | 16.5 (12.3) |
| Psoriasis involvement of body surface area ≥3%, n | 68 (40.5%) | 77 (45.8%) | 82 (48.8%) |
| PASI score (0–72),† mean (SD) | 9.1 (9.5) | 7.4 (8.7) | 9.2 (9.7) |
| Presence of enthesitis, n | 98 (58.3%) | 103 (61.3%) | 114 (67.9%) |
| MASES (0–13),‡ mean (SD) | 5.4 (3.5) | 5.0 (3.3) | 4.4 (3.1) |
| Presence of dactylitis, n | 68 (40.5%) | 59 (35.1%) | 68 (40.5%) |
| Dactylitis severity score (0–20),§ mean (SD) | 3.3 (3.3) | 4.1 (4.2) | 2.9 (2.4) |
| Prior use of DMARDs (biologic-naïve), n | 120 (71.4%) | 129 (76.8%) | 124 (73.8%) |
| Prior use of biologics, n | 41 (24.4%) | 37 (22.0%) | 41 (24.4%) |
| Prior biologic failures, n | 19 (11.3%) | 14 (8.3%) | 14 (8.3%) |
| Baseline DMARD use, n | 110 (65.5%) | 111 (66.1%) | 106 (63.1%) |
| Methotrexate (mean dose, 16.6 mg/week) | 90 (53.6%) | 95 (56.5%) | 88 (52.4%) |
| Leflunomide (mean dose, 17.2 mg/day) | 11 (6.5%) | 10 (6.0%) | 9 (5.4%) |
| Sulfasalazine (mean dose, 2.3 g/day) | 18 (10.7%) | 16 (9.5%) | 20 (11.9%) |
| Baseline corticosteroids,¶ n (mean dose, 6.1 mg/day) | 12 (7.1%) | 25 (14.9%) | 16 (9.5%) |
| Baseline use of NSAIDs, n | 118 (70.2%) | 123 (73.2%) | 120 (71.4%) |
*The n reflects the number of randomised patients; actual number of patients available for each endpoint may vary.
†Examined among patients who had body surface area ≥3% affected at baseline.
‡Examined among patients who had enthesitis at baseline.
§Examined among patients who had dactylitis at baseline.
¶Prednisone ≤10 mg/day (or equivalent).
CDAI, Clinical Disease Activity Index; 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; NSAIDs, non-steroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; SF-36v2 PF, 36-Item Short-Form Health Survey v2 Physical Functioning domain; VAS, visual analogue scale.