Table 3.
Overview of safety and commonly reported TEAEs
| Placebo-controlled period | All apremilast exposure | |||||
|---|---|---|---|---|---|---|
| Placebo [n = 2084] 622.2 patient-years | Apremilast 30 mg bid [n = 2673] 848.8 patient-years | Apremilast 30 mg bid [n = 4183] 6788.0 patient-years | ||||
| n (%) | EAIR/100 patient-years | n (%) | EAIR/100 patient-years | n (%) | EAIR/100 patient-years | |
| Any TEAE | 1113 (53.4) | 279.1 | 1780 (66.6) | 433.5 | 3265 (78.1) | 179.5 |
| Common TEAEs (≥5% of patients) | ||||||
| Diarrhea | 123 (5.9) | 20.6 | 481 (18.0) | 66.1 | 759 (18.1) | 13.1 |
| Nausea | 115 (5.5) | 19.1 | 432 (16.2) | 58.5 | 665 (15.9) | 11.3 |
| Headache | 121 (5.8) | 20.2 | 282 (10.5) | 36.0 | 470 (11.2) | 7.6 |
| URTI | 96 (4.6) | 15.8 | 178 (6.7) | 21.7 | 537 (12.8) | 9.0 |
| Nasopharyngitis | 93 (4.5) | 15.3 | 153 (5.7) | 18.6 | 491 (11.7) | 8.1 |
| Arthralgia | 39 (1.9) | 6.3 | 53 (2.0) | 6.3 | 227 (5.4) | 3.5 |
| Hypertension | 46 (2.2) | 7.5 | 50 (1.9) | 6.0 | 211 (5.0) | 3.3 |
A TEAE is an adverse event with a start date on or after the date of the first dose of apremilast 30 mg bid and no later than 28 days after the last dose of apremilast 30 mg bid. Each patient is counted once for each applicable category. Patient incidence is 100 times the number (n) of patients reporting the event divided by (m) the number of patients with treatment duration less than or equal to the lower bound of the exposure interval
bid twice daily, EAIR exposure-adjusted incidence rate, TEAEs treatment-emergent adverse events, URTI upper respiratory tract infection