Table 2.
Safety
| Events (E/100 PY) | Week 24 | Long-terma | ||
|---|---|---|---|---|
| RZB 150 mg (n = 483; PY = 224.1) | Any RZB 150 mg (n = 946; PY = 1708.4) | |||
| Any TEAE | 398 | (177.6) | 2223 | (130.1) |
| Serious TEAE | 15 | (6.7) | 130 | (7.6) |
| TEAE leading to discontinuation of study drug | 6 | (2.7) | 36 | (2.1) |
| COVID-19-related TEAE | 1 | (0.4) | 137 | (8.0) |
| Adjudicated MACE | 0 | 2 | (0.1) | |
| Any serious infection | 6 | (2.7) | 39 | (2.3) |
| Opportunistic infections | ||||
| Infections excluding TB and herpes zoster | 0 | 1 | (< 0.1) | |
| Active TB | 0 | 0 | ||
| Herpes zoster | 2 | (0.9) | 4 | (0.2) |
| Any hypersensitivity | 12 | (5.4) | 43 | (2.5) |
| Malignant tumors | ||||
| NMSC | 0 | 2 | (0.1) | |
| Malignancies excluding NMSC | 0 | 7 | (0.4) | |
| All deathsb | 1 | (0.4) | 7 | (0.4) |
E events, MACE major adverse cardiovascular event, NMSC nonmelanoma skin cancer, PY patient-years, RZB risankizumab, TB tuberculosis, TEAE treatment-emergent adverse event
aSafety reported through data cutoff date (March 21, 2022), which includes data though week 100 and all patients who received any RZB 150 mg (those patients who started on RZB 150 mg at randomization and those patients who switched from placebo to RZB 150 mg after week 24)
bIn the long-term safety analysis set, six total treatment-emergent deaths were reported. Death in two patients was related to COVID-19. One patient died as a result of complications related to acute leukemia. One patient with anemia died from diverticulosis and multiorgan failure due to complications of a hemicolectomy. One patient previously reported at the week 24 cutoff date, aged 81 years with dementia and hospitalized for pneumonia, developed urosepsis and complications resulting in death. One patient previously reported at the week 52 cutoff date was hospitalized for anxiety and depression 1 week after being discharged and was readmitted with septicemia. The patient was found deceased at home 2 weeks after discharge, and the death was subsequently adjudicated as sudden cardiac death. TEAEs were defined as an adverse event with an onset date on or after the first dose of RZB and up to 140 days after the last dose of RZB if the patient prematurely discontinued study drug