Table 2.
Treatment-emergent adverse events
| Risankizumab (N = 244) n (%) |
Risankizumab (PY = 265.2) E/100 PY |
|
|---|---|---|
| AE | 164 (67.2) | 408 (153.8) |
| AE with a reasonable possibility of being drug-related1 | 48 (19.7) | 93 (35.1) |
| Severe AE | 18 (7.4) | 24 (9.0) |
| Serious AE | 17 (7.0) | 21 (7.9) |
| AE leading to discontinuation of study drug | 8 (3.3) | 9 (3.4) |
| Adjudicated MACE2 | 3 (1.2) | 3 (1.1) |
| Serious infection | 3 (1.2) | 3 (1.1) |
| Tuberculosis3 | 0 | 0 |
| Malignant tumor | 4 (1.6) | 4 (1.5) |
| Malignant tumor excluding NMSC | 2 (0.8) | 2 (0.8) |
| Serious hypersensitivity | 0 | 0 |
| AE leading to death | 0 | 0 |
| Any COVID-19 related AE | 31 (12.7) | 33 (12.4) |
| All deaths4 | 0 | 0 |
| TEAE ≥ 5% | ||
| COVID-19 | 21 (8.6) | 21 (7.9) |
| Nasopharyngitis | 14 (5.7) | 18 (6.8) |
AE adverse events; PY patient-years; E/100PY = events per 100 PY; MACE major adverse cardiovascular events; NMSC non-melanoma skin cancer; TEAE treatment-emergent adverse events. TEAEs were defined as any event with an onset that was after the first dose of the study drug and with an onset date within 20 weeks (140 days) after the last dose of the study drug. Patients were counted once in each row, regardless of the number of events they may have had
1As assessed by the investigator, 2MACE was defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. The time lapse between the initiation of risankizumab and every MACE event is as follows: patient 1, MI occurred on day 356; patient 2, MI occurred on day 174; patient 3, lacunar infarct on day 176. 3Based on CMQ of active tuberculosis, 4includes non-treatment-emergent deaths