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Table 1 Summary of safety in patients with PsA through 260 weeks of apremilast treatment by treatment period

From: Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1–3 pooled analysis

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)
  1. AE adverse event, URTI upper respiratory tract infection
  2. *Includes all patients who received apremilast during the time interval relative to the start of apremilast treatment
  3. §Multiorgan failure not suspected to be treatment-related
  4. Motor vehicle accident on study day 489
  5. ||Cerebrovascular accident on day 1330 in a 69-year-old man, considered unrelated to the study drug; patient had a history of myocardial infarction, atrial fibrillation, and cerebrovascular accident
  6. #Stroke on day 1224 in a 58-year-old woman, considered unrelated to the study drug; patient had a history of chronic ischemic heart disease, hypertension, alcoholism, and atrial fibrillation
  7. Heart failure on day 1462 in a 70-year-old man, considered unrelated to the study drug; patient had a history of ischemic heart disease, arrhythmia, and heart failure
  8. **Necrotizing fasciitis of the anterior abdominal wall, refractory hypotensive shock, and acute renal failure considered not related to apremilast by investigator; patient had a history of diabetes mellitus