Table 3.
Patients with treatment-emergent adverse events in period A
| Adverse events, n (%) | Placebo (n = 34) | Risankizumab 150 mg (n = 69) | Risankizumab 300 mg (n = 69) |
|---|---|---|---|
| Any TEAE | 24 (70.6) | 38 (55.1) | 39 (56.5) |
| Most common AEsa | |||
| Worsening of AD | 8 (23.5) | 19 (27.5) | 16 (23.2) |
| Pruritus | 2 (5.9) | 2 (2.9) | 5 (7.2) |
| Nasopharyngitis | 0 | 4 (5.8) | 4 (5.8) |
| Serious AEsb | 3 (8.8) | 0 | 0 |
| AEs leading to discontinuation | 7 (20.6) | 4 (5.8) | 2 (2.9) |
| AEs leading to death | 1 (2.9) | 0 | 0 |
| COVID-19–related deaths | 1 (2.9) | 0 | 0 |
| AEs of safety interest | |||
| Opportunistic infections excluding tuberculosis and herpes zosterc | 1 (2.9) | 1 (1.4) | 0 |
| Malignant tumors | 1 (2.9) | 0 | 0 |
| Malignant tumors excluding NMSC | 1 (2.9) | 0 | 0 |
| Serious hypersensitivity | 1 (2.9) | 0 | 0 |
| Serious infections | 1 (2.9) | 0 | 0 |
| Adjudicated anaphylactic reaction | 0 | 0 | 0 |
| MACE | 0 | 0 | 0 |
| Tuberculosis | 0 | 0 | 0 |
AD atopic dermatitis, AE adverse event, MACE major adverse cardiovascular event, NMSC non-melanoma skin cancer, TEAE treatment-emergent adverse event
aAEs reported in ≥ 5% of patients in either risankizumab treatment group
bSerious AEs included COVID-19 leading to death, stage 1 cervical cancer leading to discontinuation, and worsening of AD leading to discontinuation; none of the serious AEs was considered to be treatment-related
cIncludes human polyomavirus infection in 1 patient receiving placebo and Kaposi’s varicelliform eruption in 1 patient receiving risankizumab 150 mg