Safety overview
| Placebo | IXEQ4W | IXEQ2W | Adalimumab 40 mg Q2W* | |
|---|---|---|---|---|
| (N=106) | (N=107) | (N=102) | (N=101) | |
| TEAE, n (%) | 50 (47.2) | 71 (66.4)† | 67 (65.7)† | 65 (64.4)‡ |
| Mild | 27 (25.5) | 43 (40.2)§ | 41 (40.2)§ | 39 (38.6) |
| Moderate | 21 (19.8) | 24 (22.4) | 21 (20.6) | 25 (24.8) |
| Severe | 2 (1.9) | 4 (3.7) | 5 (4.9) | 1 (1.0) |
| Most frequent TEAEs¶, n (%) | ||||
| Injection site reaction | 0 | 13 (12.1)** | 16 (15.7)** | 2 (2.0) |
| Injection site erythema | 0 | 7 (6.5)‡ | 13 (12.7)** | 2 (2.0) |
| Nasopharyngitis | 5 (4.7) | 7 (6.5) | 3 (2.9) | 7 (6.9) |
| Headache | 1 (0.9) | 4 (3.7) | 4 (3.9) | 3 (3.0) |
| Upper respiratory tract infection | 7 (6.6) | 5 (4.7) | 3 (2.9) | 5 (5.0) |
| ALT increased | 0 | 3 (2.8) | 4 (3.9) | 3 (3.0) |
| Diarrhoea | 3 (2.8) | 2 (1.9) | 5 (4.9) | 3 (3.0) |
| Muscle spasms | 1 (0.9) | 3 (2.8) | 4 (3.9) | 1 (1.0) |
| Bronchitis | 3 (2.8) | 3 (2.8) | 3 (2.9) | 4 (4.0) |
| AST increased | 0 | 2 (1.9) | 3 (2.9) | 2 (2.0) |
| Nausea | 2 (1.9) | 0 | 5 (4.9) | 4 (4.0) |
| Psoriatic arthropathy | 1 (0.9) | 3 (2.8) | 2 (2.0) | 3 (3.0) |
| Back pain | 0 | 2 (1.9) | 2 (2.0) | 3 (3.0) |
| Serious adverse events, n (%) | 2 (1.9) | 6 (5.6) | 3 (2.9) | 5 (5.0) |
| Serious infection, n (%) | 0 | 1 (0.9) | 2 (2.0) | 2 (2.0) |
| Discontinued due to AE, n (%) | 2 (1.9) | 2 (1.9) | 4 (3.9) | 2 (2.0) |
| AEs of special interest††, n (%) | 36 (34.0) | 52 (48.6)§ | 56 (54.9)† | 45 (44.6) |
| Infection | 27 (25.5) | 30 (28.0) | 24 (23.5) | 26 (25.7) |
| Any candida infection | 0 | 1 (0.9) | 1 (1.0) | 0 |
| Active or reactivated tuberculosis | 0 | 0 | 0 | 0 |
| Injection site reactions | 5 (4.7) | 26 (24.3)** | 27 (26.5)** | 6 (5.9) |
| Hepatic event | 7 (6.6) | 5 (4.7) | 9 (8.8) | 13 (12.9) |
| Allergic reaction/hypersensitivity | 3 (2.8) | 2 (1.9) | 5 (4.9) | 5 (5.0) |
| Cytopenia (all types) | 6 (5.7) | 1 (0.9) | 4 (3.9) | 4 (4.0) |
| Neutropenia | 0 | 0 | 1 (1.0) | 0 |
| Depression | 0 | 2 (1.9) | 1 (1.0) | 1 (1.0) |
| Cerebrocardiovascular event | 0 | 0 | 0 | 3 (3.0) |
| Malignancy | 1 (0.9) | 0 | 0 | 1 (1.0) |
*The adalimumab 40 mg Q2W treatment arm served as active reference for comparison with placebo. The study was not powered to test equivalence or non-inferiority of ixekizumab versus adalimumab.
†p≤0.01 vs placebo.
‡p≤0.025 vs placebo.
§p<0.05 vs placebo.
¶Adverse events are listed according to the preferred term in MedDRA, V.17.1, and are events that occurred in ≥2.0% of the patients in the combined ixekizumab group.
**p≤0.001 vs placebo.
††Reported as adverse events and coded using MedDRA, V.17.1. Groups of adverse events of special interest are shown; adverse events of special interest not reported in any group included pneumocystis pneumonia, Crohn's disease/ulcerative colitis and interstitial lung disease.
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; IXEQ2W, 80 mg ixekizumab once every 2 weeks; IXEQ4W, 80 mg ixekizumab once every 4 weeks; MedDRA, Medical Dictionary for Regulatory Activities; Q2W, once every 2 weeks; TEAE, treatment-emergent adverse event.