Table 1.
Treatment Emergent Adverse Events with Ixekizumab and Placebo Through 24 Weeks in People with Biologic-Naïve or TNFi-Experienced Psoriatic Arthritis
| Safety Outcomes at 24 Weeks33 | Placebo | IXEQ4WK | IXEQ2WK | IXE Combined |
|---|---|---|---|---|
| N=224 | N=229 | N=225 | N=454 | |
| Any infection, n(%) | 62 (27.7%) | 77 (33.6%) | 72 (32%) | 149 (32.8%) |
| Serious infection | 0 | 1 (0.4%) | 5 (2.2%) | 6 (1.3%) |
| Candidiasis | 1 (0.4%) | 4 (1.7%) | 8 (3.6%) | 13 (2.6%) |
| Esophageal candidiasis | 0 | 0 | 1 (0.4%) | 1 (0.2%) |
| Upper respiratory infection | 16 (7.1%) | 16 (7.0%) | 15 (6.7%) | 31 (6.8%) |
| Nasopharyngitis | 9 (4.0%) | 15 (6.6%) | 7 (3.1%) | 22 (4.8%) |
| Bronchitis | 7 (3.1%) | 4 (1.7%) | 7 (3.1%) | 11 (2.4%) |
| Sinusitis | 5 (2.2%) | 9 (3.9%) | 6 (2.7%) | 15 (3.3%) |
| Urinary tract infection | 5 (2.2%) | 8 (3.5%) | 4 (1.8%) | 12 (2.6%) |
| Cytopenia | 2 (0.9%) | 2 (0.9%) | 4 (1.8%) | 6 (1.3%) |
| Hepatic events | 10 (4.5%) | 7 (3.1%) | 11 (4.9%) | 18 (4.0%) |
| Cerebro-cardiovascular events | 2 (0.9%) | 0 | 0 | 0 |
| Depression | 3 (1.3%) | 4 (1.7%) | 4 (1.8%) | 8 (1.8%) |
| Malignancies (excludes NMSC) | 0 | 2 (0.9%) | 0 | 2 (0.4%) |
| Injection site reactions* | 10 (4.5%) | 40 (17.5%) | 57 (25.3%) | 97 (21.4%) |
| Allergic or hypersensitivity reactions** | 4 (1.8%) | 10 (4.4%) | 14 (6.2%) | 24 (5.3%) |
Notes: Bold font designates statistically significant differences as calculated in the primary publications: *Injection site reactions were significantly more frequent versus placebo with both ixekizumab doses in the biologic-naïve phase III trial23 as well as the TNFi-experienced phase III trial,22 **Allergic or hypersensitivity reactions were significantly more frequent versus placebo with both ixekizumab doses in the TNFi-experienced phase III trial.22 Up to 24 weeks, there were no deaths, no occurrence of major cardiovascular adverse events, no inflammatory bowel disease, no interstitial lung disease, no pneumocystis pneumonia, and no active or latent TB.22,23,33.
Abbreviations: TEAEs, treatment emergent adverse events; NMSC, non-melanoma skin cancer; IXE, ixekizumab; IXEQ4W/IXEQ2W, ixekizumab 80 mg every 4 or every 2 weeks; ADA, adalimumab.