Table 3.
Summary of treatment-emergent adverse events of special interest during combined ixekizumab dosing
| Treatment-emergent AEs | N (%) | IRa |
|---|---|---|
| Patients treated | 5898 | |
| Injection site reactions | 892 (15.1) | 5.2 |
| Hypersensitivity/allergic reactions | 876 (14.9) | 5.2 |
| Serious infections and infestations | 223 (3.8) | 1.3 |
| Oral candidiasis | 140 (2.4) | 0.8 |
| Malignancies | 131 (2.2) | 0.8 |
| NMSC | 51 (0.9) | 0.3 |
| Other malignancies (excluding NMSC) | 86 (1.5) | 0.5 |
| Inflammatory bowel disease (narrow terms) | 26 (0.4) | 0.2 |
| Inflammatory bowel disease | 1 (0.0) | < 0.05 |
| Crohn’s disease | 7 (0.1) | < 0.05 |
| Ulcerative colitis | 18 (0.3) | 0.1 |
| MACE, adjudicated (n = 5697) | 84 (1.5) | 0.5 |
| Vascular death | 20 (0.4) | 0.1 |
| Myocardial infarction, nonfatal | 45 (0.8) | 0.3 |
| Stroke, nonfatal | 20 (0.4) | 0.1 |
AE Adverse event; IR incidence rate; MACE major adverse cardiovascular events, N total number of patients, n number of patients in category, NMSC non-melanoma skin cancer
aIncidence rates are per 100 patient-years