Patients, n (%) | RZB 150 mg N=483 | Placebo N=481 |
TEAE | 195 (40.4) | 186 (38.7) |
COVID-19-related TEAE | 1 (0.2) | 2 (0.4) |
Serious AE* | 12 (2.5) | 18 (3.7) |
Severe TEAE* | 10 (2.1) | 9 (1.9) |
TEAE leading to discontinuation of study drug | 4 (0.8) | 4 (0.8) |
Death | 1 (0.2)† | 0 |
Serious infections‡ | 5 (1.0) | 6 (1.2) |
Active tuberculosis | 0 | 0 |
Herpes zoster§ | 2 (0.4) | 1 (0.2) |
Any other opportunistic infections | 0 | 0 |
Malignancy | 0 | 2 (0.4) |
Anaphylactic reactions | 0 | 0 |
Injection site reactions¶ | 3 (0.6) | 0 |
MACE | 0 | 0 |
*Except for pneumonia, which was reported for two patients (0.4%) in the placebo group, no serious AE or severe TEAE was reported for >1 patient in either group.
†One death (urosepsis) in an 81-year-old male patient.
‡RZB: urosepsis (one patient, resulting in death), cellulitis (one patient), gastroenteritis (one patient), COVID-19 pneumonia (one patient) and viral upper respiratory tract infection leading to pneumonia (one patient); placebo: pneumonia (two patients), oral bacterial infection (one patient), dysentery (one patient), appendicitis (one patient) and cellulitis (one patient).
§All non-serious, resolved with oral antiviral agents and did not result in discontinuation of the study drug.
¶All non-serious and did not result in discontinuation of the study drug.
AE, adverse event; MACE, major adverse cardiovascular event; RZB, risankizumab; TEAE, treatment-emergent AE.