Table 3.
AEs and laboratory abnormalities during the placebo-controlled phase (week 0–24) and apremilast-exposure phase (week 0–52)
| Week 0–24* | Week 0–52† | ||||
|---|---|---|---|---|---|
| Apremilast | Apremilast | ||||
| Placebo n=168 |
20 mg twice daily n=170 |
30 mg twice daily n=167 |
20 mg twice daily n=241 |
30 mg twice daily n=242 |
|
| Overview of AEs, n (%) | |||||
| Any AE | 83 (49) | 100 (59) | 104 (62) | 160 (66) | 165 (68) |
| Any serious AE | 9 (5) | 3 (2) | 6 (4) | 13 (5) | 10 (4) |
| Any AE leading to drug withdrawal | 10 (6) | 13 (8) | 12 (7) | 22 (9) | 14 (6) |
| Death | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| AEs reported by ≥5% of patients in any treatment group, n (%) | |||||
| Diarrhoea | 3 (2) | 26 (15) | 26 (16) | 32 (13) | 33 (14) |
| Nausea | 9 (5) | 19 (11) | 23 (14) | 24 (10) | 36 (15) |
| Headache | 8 (5) | 16 (9) | 20 (12) | 26 (11) | 26 (11) |
| URTI | 3 (2) | 11 (7) | 12 (7) | 21 (9) | 20 (8) |
| Nasopharyngitis | 2 (1) | 7 (4) | 4 (2) | 12 (5) | 10 (4) |
| Vomiting | 1 (0.6) | 5 (3) | 8 (5) | 8 (3) | 12 (5) |
| Serious AEs reported by ≥2 patients in any treatment group, n (%) | |||||
| Acute pancreatitis | 2 (1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Psoriatic arthropathy | 2 (1) | 1 (0.6) | 1 (0.6) | 2 (0.8) | 1 (0.4) |
| Select laboratory assessments, n/m‡ (%) | |||||
| ALT >150 U/L | 0/167 (0) | 0/168 (0) | 2/164 (1) | 2/238 (0.8) | 2/238 (0.8) |
| Creatine (male >156, female >126 μmol/L) | 1/167 (0.6) | 0/168 (0) | 0/164 (0) | 1/238 (0.4) | 0/238 (0) |
| Haemoglobin (male: decrease >2.0 and value <10.5 g/dL; female: decrease >2.0 and value <10.0 g/dL) | 0/165 (0) | 1/162 (0.6) | 0/161 (0) | 1/232 (0.4) | 3/236 (1) |
| Leucocytes <2.0, 109/L | 0/165 (0) | 0/162 (0) | 1/161 (0.6) | 0/238 (0) | 2/238 (0.8) |
| Neutrophils <0.75, 109/L | 1/164 (0.6) | 1/161 (0.6) | 0/161 (0) | 1/238 (0.4) | 0/238 (0) |
| Platelets <75, 109/L | 0/165 (0) | 0/162 (0) | 0/161 (0) | 0/238 (0) | 0/238 (0) |
*Placebo-controlled phase includes data through week 16 for patients initially receiving placebo who escaped, and data through week 24 for all other patients.
†Includes all patients who received ≥1 dose of apremilast regardless of when apremilast was started (week 0, week 16 or week 24).
‡Represents patients with ≥1 occurrence of the abnormality (n)/patients with a baseline value and ≥1 postbaseline value for criteria requiring baseline or patients with ≥1 postbaseline value for criteria not requiring baseline (m). Individual abnormalities were infrequent and returned to baseline values with continuation of apremilast administration or were associated with a concurrent medical condition or medication.
AEs, adverse events; ALT, alanine aminotransferase; URTI, upper respiratory tract infection.