Adverse events and laboratory abnormalities during the placebo-controlled phase (weeks 0–24)*
| Patients | Apremilast | ||
|---|---|---|---|
| Placebo n=168 | 20 mg BID n=168 | 30 mg BID n=168 | |
| Overview of adverse events, n | |||
| Any adverse event | 81 (48.2%) | 101 (60.1%) | 103 (61.3%) |
| Any severe adverse event | 6 (3.6%) | 8 (4.8%) | 11 (6.5%) |
| Any serious adverse event | 7 (4.2%) | 8 (4.8%) | 9 (5.4%) |
| Any adverse event leading to drug withdrawal | 8 (4.8%) | 10 (6.0%) | 12 (7.1%) |
| Adverse events reported by ≥5% of patients in any treatment group, n | |||
| Diarrhoea | 4 (2.4%) | 19 (11.3%) | 32 (19.0%) |
| Nausea | 11 (6.5%) | 16 (9.5%) | 31 (18.5%) |
| Headache | 8 (4.8%) | 17 (10.1%) | 18 (10.7%) |
| Upper respiratory tract infection | 6 (3.6%) | 10 (6.0%) | 7 (4.2%) |
| Adverse events leading to discontinuation in >1 patient in any treatment group, n | |||
| Diarrhoea | 3 (1.8%) | 0 (0.0%) | 4 (2.4%) |
| Nausea | 2 (1.2%) | 2 (1.2%) | 3 (1.8%) |
| Migraine | 0 (0.0%) | 1 (0.6%) | 2 (1.2%) |
| Patients with select laboratory value shifts from normal to > the upper limit of normal, n† | |||
| Alanine transaminase, U/L | 20/150 (13.3%) | 12/146 (8.2%) | 12/155 (7.7%) |
| Creatinine, μmol/L | 3/159 (1.9%) | 7/151 (4.6%) | 10/158 (6.3%) |
| Patients with select laboratory value shifts from normal to < the lower limit of normal, n† | |||
| Leukocytes, 109/L | 1/155 (0.6%) | 4/155 (2.6%) | 2/159 (1.3%) |
| Neutrophils, 109/L | 2/146 (1.4%) | 2/145 (1.4%) | 5/151 (3.3%) |
| Platelets, 109/L | 0/146 (0.0%) | 0/142 (0.0%) | 1/151 (0.7%) |
| Haemoglobin, g/dL | 8/148 (5.4%) | 7/149 (4.7%) | 14/153 (9.2%) |
*The safety population in the placebo-controlled phase includes all data through week 16 for patients initially assigned to placebo who escaped, and data through week 24 for all other patients.
†Represents the number of patients with at least one occurrence of the abnormality/the number of patients with a baseline value of normal and at least one post-baseline. Individual abnormalities were infrequent and returned to baseline values with continuation of apremilast administration or were associated with a concurrent medical condition or medication. There were no cases of liver function test elevations meeting Hy's Law.