Table 4.
Patients with treatment-emergent adverse events in period B
| Adverse events, n (%) | Placebo/Risankizumab 150 mg (n = 13) | Placebo/Risankizumab 300 mg (n = 11) | Risankizumab 150 mg (n = 61) | Risankizumab 300 mg (n = 57) |
|---|---|---|---|---|
| Any TEAE | 6 (46.2) | 5 (45.5) | 29 (47.5) | 29 (50.9) |
| Most common AEsa | ||||
| Worsening of AD | 2 (15.4) | 1 (9.1) | 7 (11.5) | 5 (8.8) |
| Nasopharyngitis | 0 | 0 | 4 (6.6) | 3 (5.3) |
| Cellulitis | 0 | 0 | 1 (1.6) | 2 (3.5) |
| Blood creatine phosphokinase increased | 0 | 0 | 0 | 2 (3.5) |
| C-reactive protein increased | 0 | 0 | 2 (3.3) | 0 |
| Pruritus | 0 | 0 | 2 (3.3) | 0 |
| Toothache | 0 | 2 (18.2) | 0 | 0 |
| COVID-19-related TEAE | 0 | 0 | 0 | 1 (1.8) |
| Serious AEsb | 0 | 0 | 2 (3.3) | 3 (5.3) |
| AEs leading to discontinuation | 2 (15.4) | 0 | 2 (3.3) | 0 |
| AEs leading to death | 0 | 0 | 0 | 0 |
| AEs of safety interest | ||||
| Opportunistic infections excluding tuberculosis and herpes zosterc | 0 | 0 | 1 (1.6) | 1 (1.8) |
| Serious infections | 0 | 0 | 1 (1.6) | 1 (1.8) |
| Malignant tumors | 0 | 0 | 1 (1.6) | 0 |
| Adjudicated anaphylactic reaction | 0 | 0 | 0 | 0 |
| Malignant tumors excluding NMSC | 0 | 0 | 0 | 0 |
| MACE | 0 | 0 | 0 | 0 |
| Serious hypersensitivity | 0 | 0 | 0 | 0 |
| Tuberculosis | 0 | 0 | 0 | 0 |
AD atopic dermatitis, AEs adverse events, MACE major adverse cardiovascular event, NMSC non-melanoma skin cancer, TEAE treatment-emergent adverse event
aAEs reported in ≥ 2 patients in any treatment group
bIn the risankizumab 150 mg group, serious AEs included cardiac arrhythmia and cellulitis; the investigator believed there was a reasonable possibility that the cellulitis was treatment-related. In the risankizumab 300 mg group, serious AEs included worsening of osteoarthritis (n = 1); amaurosis fugax (n = 1); and coccyx fracture, vertebral fracture, and cellulitis in 1 patient; none of the serious AEs was considered to be treatment-related
cIncludes 1 patient each with cellulitis and 1 patient each with Kaposi’s varicelliform eruption in the continuous risankizumab 150 mg and 300 mg groups