Safety outcomes
| IXE (n=283) | ADA (n=283) | |
| Extent of exposure, mean days (total patient-years) | 236.8 (183.5) | 228.9 (117.3) |
| Treatment-emergent adverse events | 197 (69.6) | 173 (61.1) |
| Mild | 97 (34.3) | 87 (30.7) |
| Moderate | 91 (32.2) | 71 (25.1) |
| Severe | 9 (3.2) | 15 (5.3) |
| Serious adverse events | 10 (3.5) | 24 (8.5) |
| Deaths | 0 | 0 |
| Discontinuations due to adverse events | 7 (2.5) | 13 (4.6) |
| Adverse events of special interest | ||
| Infections | 102 (36.0) | 87 (30.7) |
| Serious infections | 4 (1.4) | 8 (2.8) |
| Candida infections | 7 (2.5) | 2 (0.7) |
| Injection-site reactions | 27 (9.5) | 9 (3.2) |
| Allergic/hypersensitivity reactions | 7 (2.5) | 11 (3.9) |
| Potential anaphylaxis | 0 | 0 |
| Cytopaenias | 5 (1.8) | 11 (3.9) |
| Cerebrocardiovascular events* | 3 (1.1) | 5 (1.8) |
| Malignancies | 0 | 3 (1.1) |
| Depression | 3 (1.1) | 7 (2.5) |
| Inflammatory bowel disease | 2 (0.7)† | 0 |
| Ulcerative colitis | 1 (0.4)‡, | 0 |
| Crohn’s disease | 1 (0.4)§ | 0 |
Safety data were analysed in the safety population at the time of database lock. Of the 566 randomized patients, n=70 completed, n=52 discontinued, and n=444 were ongoing in the open label treatment period at the time of database lock.
*Of eight treatment-emergent cerebrocardiovascular events reported, four (IXE: n=2 (0.7%); ADA: n=2 (0.7%)) were adjudicated.
†EPIdemiologique des Maladies de l’Appareil Digestif (EPIMAD) criteria for adjudication of suspected inflammatory bowel disease define ‘probable’ and ‘definite’ classifications as confirmed cases. Only one case met the EPIMAD criteria of confirmed inflammatory bowel disease.
‡Event was reported as colitis ulcerative and was adjudicated as possible ulcerative colitis.
§Event was reported as colitis and was adjudicated as probable Crohn’s disease.
ADA, adalimumab; IXE, ixekizumab.