Table 1.
Baseline demographics and disease characteristics, by treatment group in patients with enthesitis or dactylitis at baseline
| Patients with enthesitis at baseline (n=945) | Patients with dactylitis at baseline (n=633) | |||||
| Placebo (n=311) |
Apremilast | Placebo (n=205) |
Apremilast | |||
| 30 mg two times per day (n=327) | 20 mg two times per day (n=307) | 30 mg two times per day (n=221) | 20 mg two times per day (n=207) | |||
| Age, mean, years | 50.2 | 50.8 | 49.7 | 49.2 | 49.5 | 47.8 |
| Females, n (%) | 174 (55.9) | 196 (59.9) | 175 (57.0) | 106 (51.7) | 105 (47.5) | 101 (48.8) |
| Body mass index, mean, kg/m2 | 30.5 | 30.1 | 30.4 | 30.6 | 29.5 | 29.6 |
| Duration of PsA, mean, years | 7.3 | 7.4 | 7.1 | 7.2 | 7.7 | 8.0 |
| Duration of psoriasis, mean, years | 18.0 | 17.6 | 17.9 | 17.1 | 17.3 | 17.6 |
| Swollen joint count (0–76), mean (SD) | 11.6 (8.3) | 12.3 (8.5) | 12.4 (9.3) | 13.3 (8.7) | 14.2 (9.8) | 14.0 (10.2) |
| Tender joint count (0–78), mean (SD) | 22.6 (15.9) | 25.1 (15.7) | 24.9 (17.9) | 22.4 (15.7) | 23.9 (15.0) | 24.7 (18.5) |
| MASES* (0–13), mean (SD) | 4.8 (3.3) | 4.5 (3.2) | 4.6 (3.3) | 4.8 (3.4) | 4.1 (2.7) | 4.8 (3.4) |
| Median (minimum, maximum) | 4.0 (1, 13) | 4.0 (1, 13) | 4.0 (1, 13) | 4.0 (1, 13) | 4.0 (1, 13) | 4.0 (1,13) |
| Dactylitis count† (0–20), mean (SD) | 3.4 (3.5) | 3.7 (3.6) | 3.8 (3.9) | 3.2 (3.3) | 3.3 (3.3) | 3.4 (3.4) |
| Median (minimum, maximum) | 2.0 (1, 20) | 3.0 (1, 19) | 2.0 (1, 20) | 2.0 (1, 20) | 2.0 (1, 19) | 2.0 (1, 20) |
| HAQ-DI score (0–3), mean (SD) | 1.3 (0.60) | 1.3 (0.62) | 1.3 (0.61) | 1.3 (0.62) | 1.3 (0.64) | 1.2 (0.68) |
| CRP (normal range: 0–0.499), mean, mg/dL | 1.10 (1.6) | 1.00 (1.5) | 0.94 (1.3) | 1.17 (1.5) | 1.21 (1.7) | 1.05 (1.3) |
| DAS-28 (CRP), mean (SD) | 4.8 (1.1) | 4.9 (1.0) | 4.8 (1.0) | 4.8 (1.1) | 4.9 (1.0) | 4.7 (1.2) |
| PASI score‡ (0–72), mean | 8.8 (9.7) | 8.4 (7.9) | 7.5 (7.1) | 8.1 (7.7) | 8.5 (8.6) | 7.8 (6.6) |
| Psoriasis body surface area, mean, % | 7.8 | 7.9 | 7.4 | 8.4 | 8.2 | 8.5 |
| Prior use of conventional DMARDs only, n (%) | 242 (77.8) | 252 (77.1) | 223 (72.6) | 157 (76.6) | 178 (80.5) | 167 (80.7) |
| Prior use of biologicals, n (%) | 62 (19.9) | 70 (21.4) | 81 (26.4) | 45 (22.0) | 41 (18.6) | 40 (19.3) |
| Prior biological failures, n (%) | 29 (9.3) | 28 (8.6) | 28 (9.1) | 20 (9.8) | 14 (6.3) | 10 (4.8) |
| Concomitant conventional DMARD use, n (%) | 201 (64.6) | 206 (63.0) | 192 (62.5) | 138 (67.3) | 145 (65.6) | 146 (70.5) |
| Methotrexate (mean dose, 15.3 mg/week*; 15.2 mg/week†) | 172 (55.3) | 172 (52.6) | 158 (51.5) | 118 (57.6) | 121 (54.8) | 127 (61.4) |
| Leflunomide (mean dose, 17.9 mg/day*; 17.7 mg/day†) | 20 (6.4) | 19 (5.8) | 20 (6.5) | 15 (7.3) | 19 (8.6) | 15 (7.2) |
| Sulfasalazine (mean dose, 2.03 g/day*; 1.94 g/day†) |
31 (10.0) | 31 (9.5) | 31 (10.1) | 19 (9.3) | 22 (10.0) | 22 (10.6) |
| Corticosteroid use (mean dose, 6.29 mg/day*; 6.27 mg/day†), n (%) | 29 (9.3) | 38 (11.6) | 59 (19.2) | 19 (9.3) | 23 (10.4) | 35 (16.9) |
| Baseline NSAID use, n (%) | 218 (70.1) | 233 (71.3) | 221 (72.0) | 137 (66.8) | 162 (73.3) | 154 (74.4) |
The n reflects the number of randomised patients who received at least one dose of study medication; actual number of patients available for each parameter may vary.
*Examined among patients who had enthesitis at baseline.
†Examined among patients who had dactylitis at baseline.
‡Patients with baseline psoriasis involvement of the body surface area of ≥3%.
§All converted to oral prednisone dose.
Note: The n reflects the number of randomised patients who received at least one dose of study medication; actual number of patients available for each parameter may vary.
CRP, C reactive protein; DAS-28, 28-joint count Disease Activity Score; DMARD, disease-modifying anti-rheumatic drug; HAQ-DI, Health Assessment Questionnaire-Disability Index; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; NSAID, non-steroidal anti-inflammatory drug; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis.