Table 2

Safety summary (safety analysis set)

TEAE—n (%)Brodalumab 210 mg
Any TEAE44 (55.0)45 (57.0)
 Other serious TEAEs*4 (5.0)1 (1.3)
 Other significant TEAEs†4 (5.0)3 (3.8)
Any drug-related TEAE26 (32.5)20 (25.3)
 Other serious TEAEs*1 (1.3)0
 Other significant TEAEs†2 (2.5)3 (3.8)
TEAEs of interest‡—n (%)
Any TEAE7 (8.8)2 (2.5)
Inflammatory bowel disease§4 (5.0)2 (2.5)
 Mouth ulceration3 (3.8)1 (1.3)
 Stomatitis1 (1.3)1 (1.3)
Neutrophil count decreased1 (1.3)0
 Leucopenia1 (1.3)0
Serious infections2 (2.5)0
 Herpes zoster oticus1 (1.3)0
 External ear cellulitis1 (1.3)0
Suicide/self-injury-related events00
Serious hypersensitivity00
  • *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.