Table 3.

Safety summary

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.