Table 3.
Adverse events Weeks 12–60a of UNCOVER-2 and -3
| UNCOVER-2 (sPGA 0/1 NR) | UNCOVER-3 (PASI 75 NR) | |||
|---|---|---|---|---|
| PBO/IXEQ4W (N = 155) (PY = 134.3) n (IR) | ETN/IXEQ4W (N = 200) (PY = 174.4) n (IR) | PBO/IXEQ4W (N = 169) (PY = 233.0) n (IR) | ETN/IXEQ4W (N = 165) (PY = 217.0) n (IR) | |
| TEAE | 125 (93.0) | 158 (90.6) | 137 (58.8) | 125 (57.6) |
| Mild | 42 (31.3) | 56 (32.1) | 50 (21.5) | 40 (18.4) |
| Moderate | 65 (48.4) | 85 (48.8) | 68 (29.2) | 71 (32.7) |
| Severe | 18 (13.4) | 17 (9.8) | 19 (8.2) | 14 (6.5) |
| SAE | 12 (8.9) | 9 (5.2) | 20 (8.6) | 13 (6.0) |
| AE leading to discontinuation | 8 (6.0) | 8 (4.6) | 8 (3.4) | 7 (3.2) |
| Injection site reactions | 17 (12.7) | 24 (13.8) | 16 (6.9) | 11 (5.1) |
| Infections | 86 (64.0) | 111 (63.7) | 93 (39.9) | 85 (39.2) |
| Candida | 1 (0.7) | 3 (1.7) | 0 | 0 |
| Crohn’s disease | 1 (0.7) | 0 | 1 (0.4) | 0 |
| Ulcerative colitis | 0 | 0 | 0 | 0 |
AE adverse event, ETN etanercept, ETN-NR/IXEQ4W etanercept Weeks 0-12, placebo at Week 12, and ixekizumab every 4 weeks for Weeks 16–60, IR incidence rate/100 patient years, NR non-responder, PBO placebo, PBO-NR/IXEQ4W placebo Weeks 0-12 and ixekizumab every 4 weeks for Weeks 16–60 after a starting dose of 160 mg at Week 12, PY patient years, SAE serious AE, TEAE treatment-emergent AE
aSafety data for UNCOVER-3 are based on the data reported at the time of the Week 60 interim database lock; therefore, some events occurred beyond 60 weeks