Table 2.
Exposure-adjusted rates (>2 per 100 PY) of TEAEs by PT and other important TEAEs
| TEAEs by PT (>2 per 100 PY) | Brodalumab 210 mg PY = 163.0 n = 148a |
|
|---|---|---|
| n | r | |
| Any | 417 | 255.9 |
| Nasopharyngitis | 58 | 35.6 |
| Upper respiratory tract infection | 24 | 14.7 |
| Alanine aminotransferase increased | 8 | 4.9 |
| Diarrhoea | 8 | 4.9 |
| Aspartate aminotransferase increased | 7 | 4.3 |
| Gastroenteritis | 7 | 4.3 |
| Oropharyngeal pain | 7 | 4.3 |
| Hyperuricaemia | 6 | 3.7 |
| Influenza | 6 | 3.7 |
| Mouth ulceration | 6 | 3.7 |
| Arthralgia | 5 | 3.1 |
| Back pain | 5 | 3.1 |
| Insomnia | 5 | 3.1 |
| Urticaria | 5 | 3.1 |
| Uveitis | 5 | 3.1 |
| Hypertension | 4 | 2.5 |
| Influenza-like illness | 4 | 2.5 |
| Ligament sprain | 4 | 2.5 |
| Liver function test abnormal | 4 | 2.5 |
| Otitis externa | 4 | 2.5 |
| Pharyngitis | 4 | 2.5 |
| Tonsillitis | 4 | 2.5 |
| Other important TEAEsb | n | r |
| Acute myocardial infarction | 1 | 0.6 |
| Tinea pedis | 1 | 0.6 |
| Oral candidiasis | 1 | 0.6 |
| Tinea faciei | 1 | 0.6 |
| Tinea cruris | 1 | 0.6 |
| Depression | 0 | 0 |
| Suicidal ideation | 0 | 0 |
| Suicide | 0 | 0 |
| Deep vein thrombosis/pulmonary embolism | 0 | 0 |
n, number of adverse events; r, exposure-adjusted event rate per 100 PY.
a
Number of patients who received ≥1 dose of brodalumab during the study.
b
Other important TEAEs include major adverse cardiovascular events, deep vein thrombosis/pulmonary embolism, candida infection (mucosal, systemic), uveitis and suicide/self-injury-related events.
PT: preferred term; PY: patient-years; TEAE: treatment-emergent adverse event.