Table 2.
Summary of safety during risankizumab treatment
| Events (E/100 PYs) | Week 24 |
Long-terma |
|---|---|---|
| RZB 150 mg | Any RZB 150 mg | |
| n = 483 | n = 946 | |
| PYs = 224.1 | PYs = 958.1 | |
| Any TEAE | 398 (177.6) | 1371 (143.1) |
| Serious TEAE | 15 (6.7) | 71 (7.4) |
| TEAE leading to discontinuation of study drug | 6 (2.7) | 22 (2.3) |
| COVID-19 related TEAE | 1 (0.4) | 61 (6.4) |
| MACE | 0 | 0 |
| Serious infections | 6 (2.7) | 27 (2.8) |
| Opportunistic infections excluding TB and herpes zoster | 0 | 1 (0.1) |
| Active TB | 0 | 0 |
| Herpes zoster | 2 (0.9) | 4 (0.4) |
| Malignant tumors | ||
| NMSC | 0 | 6 (0.6) |
| Other | 0 | 4 (0.4) |
| All deathsb | 1 (0.4) | 2 (0.2) |
Safety reported through data cut-off date (19 April 2021), which includes data though week 52 and all patients who received any RZB 150 mg, including those who started on RZB 150 mg at randomization and who switched from placebo to RZB 150 mg after week 24.
An 81-year-old male patient randomized to RZB on day 1 died of urosepsis on day 96, and a 41-year-old male patient randomized to RZB on day 1 experienced sudden death on day 502.
TEAEs were defined as an adverse event with an onset date that is on or after the first dose of RZB and up to 140 days after the last dose of RZB if patient discontinued study drug prematurely.
E: events; MACE: major adverse cardiovascular events; NMSC: non-melanoma skin cancer; PYs: patient-years; RZB: risankizumab; TB: tuberculosis; TEAE: treatment-emergent adverse events.