Table 4.
Summary of adverse events
| Safety populationa (double‐blind treatment period) | All‐IXE safety populationb (all treatment periods) | ||
|---|---|---|---|
| Placebo (n = 56) | IXE Q4W (n = 115) | IXE Q4W (n = 196) | |
| Patient‐years of exposure | 26·9 | 12·9 | 253·9 |
| Treatment‐emergent adverse events | 25 (45) | 64 (56) | 161 (82) |
| Mild | 16 (29) | 47 (41) | 80 (41) |
| Moderate | 9 (16) | 17 (15) | 72 (37) |
| Severe | 0 | 0 | 9 (5) |
| Discontinuation due to adverse event | 1 (2) | 0 | 3 (2) |
| Serious adverse events | 0 | 1 (1) | 13 (7) |
| Deaths | 0 | 0 | 0 |
| Adverse events of special interest | |||
| Infections | 14 (25) | 37 (32) | 129 (66) |
| Serious infections | 0 | 0 | 2 (1) |
| Opportunistic infections | 0 | 0 | 0 |
| Injection‐site reactions | 1 (2) | 14 (12) | 39 (20) |
| Allergic reactions/hypersensitivty | 1 (2) | 6 (5) | 16 (8) |
| Potential anaphylaxis | 0 | 0 | 0 |
| Cytopenia | 0 | 1 (1) | 3 (2) |
| Hepatic | 0 | 0 | 4 (2) |
| Malignancies | 0 | 0 | 0 |
| Depression | 0 | 1 (1) | 6 (3) |
| Interstitial lung disease | 0 | 0 | 0 |
| IBD | 0 | 1 (1) | 4 (2) |
| Crohn's disease | 0 | 1 (1) | 4 (2) |
| Ulcerative colitis | 0 | 0 | 0 |
The data are presented as n (%). (Except patient‐years of exposure.) IBD, inflammatory bowel disease; IXE, ixekizumab; Q4W, every 4 weeks. aIncludes all randomized patients who took at least one dose of double‐blind study treatment according to the treatment to which they were assigned. bIncludes all patients who received at least one dose of IXE, including those randomized to placebo or etanercept at week 0 who received open‐label IXE Q4W during the maintenance period.