Table 1 Summary of safety in patients with PsA through 260 weeks of apremilast treatment by treatment period
Patients, n (%) | Apremilast-exposure period* | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
Weeks 0 to ≤ 52 | Weeks > 52 to ≤ 104 | Weeks > 104 to ≤ 156 | Weeks > 156 to ≤ 208 | Weeks > 208 to ≤ 260 | ||||||
30 mg twice daily (n = 721) | 20 mg twice daily (n = 720) | 30 mg twice daily (n = 520) | 20 mg twice daily (n = 508) | 30 mg twice daily (n = 443) | 20 mg twice daily (n = 422) | 30 mg twice daily (n = 401) | 20 mg twice daily (n = 366) | 30 mg twice daily (n = 364) | 20 mg twice daily (n = 320) | |
Patients with | ||||||||||
≥ 1 AE | 526 (73.0) | 507 (70.4) | 316 (60.8) | 326 (64.2) | 287 (64.8) | 273 (64.7) | 238 (59.4) | 219 (59.8) | 179 (49.2) | 188 (58.8) |
≥ 1 serious AE | 47 (6.5) | 40 (5.6) | 35 (6.7) | 39 (7.7) | 40 (9.0) | 33 (7.8) | 27 (6.7) | 28 (7.7) | 21 (5.8) | 21 (6.6) |
≥ 1 serious infection | 6 (0.8) | 3 (0.4) | 5 (1.0) | 8 (1.6) | 4 (0.9) | 5 (1.2) | 4 (1.0) | 5 (1.4) | 7 (1.9) | 5 (1.6) |
AE leading to study withdrawal | 57 (7.9) | 52 (7.2) | 13 (2.5) | 11 (2.2) | 7 (1.6) | 10 (2.4) | 8 (2.0) | 11 (3.0) | 5 (1.4) | 2 (0.6) |
Death | 0 (0.0) | 1§ (0.1) | 1‡ (0.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2||# (0.5) | 1¶ (0.3) | 1** (0.3) | 0 (0.0) |
AEs occurring in ≥ 5% of any treatment group/period | ||||||||||
Diarrhea | 113 (15.7) | 89 (12.4) | 20 (3.8) | 10 (2.0) | 12 (2.7) | 13 (3.1) | 5 (1.2) | 3 (0.8) | 2 (0.5) | 6 (1.9) |
Nausea | 108 (15.0) | 69 (9.6) | 11 (2.1) | 8 (1.6) | 10 (2.3) | 4 (0.9) | 3 (0.7) | 6 (1.6) | 1 (0.3) | 4 (1.3) |
Headache | 75 (10.4) | 61 (8.5) | 17 (3.3) | 15 (3.0) | 12 (2.7) | 11 (2.6) | 8 (2.0) | 9 (2.5) | 2 (0.5) | 8 (2.5) |
URTI | 60 (8.3) | 71 (9.9) | 27 (5.2) | 40 (7.9) | 24 (5.4) | 30 (7.1) | 22 (5.5) | 27 (7.4) | 21 (5.8) | 18 (5.6) |
Nasopharyngitis | 41 (5.7) | 48 (6.7) | 31 (6.0) | 29 (5.7) | 20 (4.5) | 30 (7.1) | 27 (6.7) | 26 (7.1) | 24 (6.6) | 22 (6.9) |
Select laboratory assessments, n/m (%) | ||||||||||
ALT, > 3× ULN | 9/713 (1.3) | 8/713 (1.1) | 2/518 (0.4) | 1/502 (0.2) | 2/442 (0.5) | 2/419 (0.5) | 1/401 (0.2) | 2/364 (0.5) | 1/363 (0.3) | 4/319 (1.3) |
Creatinine, > 1.7× ULN, μmol/L | 1/713 (0.1) | 1/713 (0.1) | 0/518 (0.0) | 0/502 (0.0) | 0/442 (0.0) | 1/419 (0.2) | 1/401 (0.2) | 4/364 (1.1) | 1/363 (0.3) | 3/319 (0.9) |
Hemoglobin < 10.5 g/dL (male) or < 8.5 g/dL (female) | 5/713 (0.7) | 5/712 (0.7) | 4/517 (0.8) | 0/503 (0.0) | 5/442 (1.1) | 2/419 (0.5) | 5/401 (1.2) | 2/364 (0.5) | 5/362 (1.4) | 1/319 (0.3) |
Leukocytes < 1.5 × 109/L | 0/713 (0.0) | 0/712 (0.0) | 0/517 (0.0) | 0/503 (0.0) | 0/442 (0.0) | 0/419 (0.0) | 0/401 (0.0) | 0/364 (0.0) | 0/362 (0.0) | 0/319 (0.0) |
Neutrophils < 1 × 109 L | 2/713 (0.3) | 4/712 (0.6) | 3/517 (0.6) | 2/502 (0.4) | 2/442 (0.5) | 1/419 (0.2) | 2/401 (0.5) | 2/364 (0.5) | 4/362 (1.1) | 1/319 (0.3) |
Platelets < 75 × 109/L | 0/713 (0.0) | 0/712 (0.0) | 0/517 (0.0) | 1/503 (0.2) | 1/441 (0.2) | 1/419 (0.2) | 0/399 (0.0) | 0/364 (0.0) | 2/362 (0.6) | 0/319 (0.0) |