Table 3. Summary of Adverse Events From Ixekizumab Treatment at Week 108.
| All-ixekizumab safety populationa | ||
|---|---|---|
| Combined treatment periods, No. (%) | IR per 100 patient-years | |
| No. | 196 | NA |
| Total | NA | 342.81 |
| TEAEsb | 172 (87.7) | 50.2 |
| Mild | 81 (41.3) | 23.6 |
| Moderate | 79 (40.3) | 23.0 |
| Severe | 12 (6.1) | 3.5 |
| Discontinuation from AEs | 5 (2.6) | 1.5 |
| SAEs | 15 (7.7) | 4.4 |
| Death | 0 | 0 |
| AEs of special interest | ||
| Infections | 145 (74.0) | 42.3 |
| Candidal | 0 | 0 |
| Opportunistic | 2 (1.0) | 0.6 |
| Injection-site reactions | 40 (20.4) | 11.7 |
| Allergic reactions or hypersensitivity | 20 (10.2) | 5.8 |
| Potential anaphylaxis | 0 | 0 |
| Cytopeniac | 3 (1.5) | 0.9 |
| Hepaticd | 4 (2.0) | 1.2 |
| Malignant neoplasme | 1 (0.5) | 0.3 |
| Depression | 8 (4.1) | 2.3 |
| ILD | 0 | 0 |
| IBDf | 4 (2.0) | 1.2 |
Abbreviations: AE, adverse event; IBD, inflammatory bowel disease; ILD, interstitial lung disease; IR, incidence rate; NA, not applicable; SAE, serious AE; TEAE, treatment-emergent AE.
All patients who received at least 1 dose of ixekizumab, including patients who were initially randomized to receive placebo or etanercept. Patients with multiple occurrences of these categories were counted once for each category. Patients may be counted in more than 1 category.
TEAE was an event that first occurred or worsened in severity after baseline and on or before the date of the last visit within current ixekizumab treatment period. The association of the TEAE with study treatment was judged by the investigator. Patients with multiple occurrences of the same event were counted under the highest severity.
Included broad and narrow grades of neutropenia and leukopenia.
Included broad and narrow liver investigations; signs and symptoms; and hepatic failure, fibrosis and cirrhosis, and other liver damage–related conditions.
Malignant neoplasm in this patient was an astrocytoma.
IBD included 2 cases of Crohn disease.