Safety summary (safety analysis set)
| TEAE—n (%) | Brodalumab 210 mg N=80 | Placebo N=79 |
| Any TEAE | 44 (55.0) | 45 (57.0) |
| Deaths | 0 | 0 |
| Other serious TEAEs* | 4 (5.0) | 1 (1.3) |
| Other significant TEAEs† | 4 (5.0) | 3 (3.8) |
| Any drug-related TEAE | 26 (32.5) | 20 (25.3) |
| Deaths | 0 | 0 |
| Other serious TEAEs* | 1 (1.3) | 0 |
| Other significant TEAEs† | 2 (2.5) | 3 (3.8) |
| TEAEs of interest‡—n (%) | ||
| Any TEAE | 7 (8.8) | 2 (2.5) |
| Inflammatory bowel disease§ | 4 (5.0) | 2 (2.5) |
| Mouth ulceration | 3 (3.8) | 1 (1.3) |
| Stomatitis | 1 (1.3) | 1 (1.3) |
| Neutrophil count decreased | 1 (1.3) | 0 |
| Leucopenia | 1 (1.3) | 0 |
| Serious infections | 2 (2.5) | 0 |
| Herpes zoster oticus | 1 (1.3) | 0 |
| External ear cellulitis | 1 (1.3) | 0 |
| Suicide/self-injury-related events | 0 | 0 |
| Serious hypersensitivity | 0 | 0 |
| Malignancy | 0 | 0 |
*Any serious TEAE other than death.
†Any non-serious TEAE leading to withdrawal of the study drug or dose suspension.
‡TEAEs identified or considered as potential risks were assessed as ‘TEAEs of interest’ and labelled in the following six categories: neutrophil count decreased/serious infections/serious hypersensitivity (identified risks) and malignancy/inflammatory bowel disease/suicide or self-injury-related events (potential risks) (online supplemental tables S3 and S4).
§Ulcerative colitis or Crohn’s disease was not reported in any patient.
TEAE, treatment-emergent adverse event.