Table 3

Safety summary

Patients, n (%)RZB 150 mg
N=483
Placebo
N=481
TEAE195 (40.4)186 (38.7)
COVID-19-related TEAE1 (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 drug4 (0.8)4 (0.8)
Death1 (0.2)†0
Serious infections‡5 (1.0)6 (1.2)
Active tuberculosis00
Herpes zoster§2 (0.4)1 (0.2)
Any other opportunistic infections00
Malignancy02 (0.4)
Anaphylactic reactions00
Injection site reactions¶3 (0.6)0
MACE00
  • *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.