Table 3. Treatment-Emergent AEs During Part A1 and Part B.
| Treatment-emergent AE | No. (%) of Patients | |
|---|---|---|
| Part A1 | ||
| Treatment | Risankizumab (n = 407) | Placebo (n = 100) |
| Adverse event | ||
| Any | 186 (45.7) | 49 (49.0) |
| Serious | 8 (2.0) | 8 (8.0) |
| Severe | 7 (1.7) | 4 (4.0) |
| Leading to drug discontinuation | 2 (0.5) | 4 (4.0) |
| Infections | 70 (17.2) | 18 (18.0) |
| Serious | 1 (0.2) | 1 (1.0) |
| Tuberculosisa | ||
| Active | 0 | 0 |
| Latent | 0 | 0 |
| Adjudicated major adverse cardiovascular event | 0 | 1 (1.0) |
| Cancers | 3 (0.7) | 0 |
| Excluding nonmelanoma skin cancer | 2 (0.5) | 0 |
| Serious hypersensitivity | 0 | 0 |
| Deaths (including non–treatment emergent) | 0 | 0 |
| Part B | ||
| Treatment | Risankizumab/risankizumab (n = 111) | Risankizumab/placebo (n = 225) |
| Adverse event | ||
| Any | 91 (82.0) | 155 (68.9) |
| Serious | 13 (11.7) | 17 (7.6) |
| Severe | 9 (8.1) | 16 (7.1) |
| Leading to drug discontinuation | 4 (3.6) | 4 (1.8) |
| Infections | 66 (59.5) | 105 (46.7) |
| Serious | 2 (1.8) | 2 (0.9) |
| Tuberculosisa | ||
| Active | 0 | 0 |
| Latent | 0 | 0 |
| Adjudicated major adverse cardiovascular event | 2 (1.8)b | 0 |
| Cancers | 2 (1.8) | 6 (2.7) |
| Excluding nonmelanoma skin cancer | 0 | 4 (1.8) |
| Serious hypersensitivity | 0 | 0 |
| Deaths (including nontreatment emergent) | 2 (1.8)c | 0 |
Abbreviation: AE, adverse event.
a
Tuberculosis testing was performed at screening and at the end of treatment using interferon-gamma release assay or purified protein derivative skin test.
b
One event of stroke and death of unknown cause.
c
One death due to epileptic seizures and 1 death of unknown cause.