Table 5.
Patients with treatment-emergent adverse events in the all-risankizumab population
| Adverse events, n (%) | Risankizumab 150 mg n = 82 | Risankizumab 300 mg n = 80 | Overall N = 162 |
|---|---|---|---|
| Any TEAE | 57 (69.5) | 55 (68.8) | 112 (69.1) |
| Most common AEsa | |||
| Worsening of AD | 27 (32.9) | 20 (25.0) | 47 (29.0) |
| Nasopharyngitis | 8 (9.8) | 7 (8.8) | 15 (9.3) |
| Pruritus | 4 (4.9) | 5 (6.3) | 9 (5.6) |
| URTI | 2 (2.4) | 4 (5.0) | 6 (3.7) |
| Impetigo | 1 (1.2) | 4 (5.0) | 5 (3.1) |
| COVID-19–related TEAE | 0 | 1 (1.3) | 1 (0.6) |
| Serious AEsb | 2 (2.4) | 3 (3.8) | 5 (3.1) |
| AEs leading to discontinuation | 8 (9.8) | 2 (2.5) | 10 (6.2) |
| AEs leading to death | 0 | 0 | 0 |
| AEs of safety interest | |||
| Serious infections | 1 (1.2) | 1 (1.3) | 2 (1.2) |
| Opportunistic infections excluding tuberculosis and herpes zosterc | 1 (1.2) | 1 (1.3) | 2 (1.2) |
| Malignant tumors | 1 (1.2) | 0 | 1 (0.6) |
| Adjudicated anaphylactic reaction | 0 | 0 | 0 |
| Malignant tumors excluding NMSC | 0 | 0 | 0 |
| MACE | 0 | 0 | 0 |
| Serious hypersensitivity | 0 | 0 | 0 |
| Tuberculosis | 0 | 0 | 0 |
AD atopic dermatitis, AEs adverse events, MACE major adverse cardiovascular event, NMSC non-melanoma skin cancer, TEAE treatment-emergent adverse event, URTI upper respiratory tract infection
aAEs reported in > 3% of patients in the overall risankizumab population
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