Table 3

Safety summary

Patients, n (%)RZB 150 mg
N=224
PBO
N=219
TEAE124 (55.4)120 (54.8)
COVID-19-related TEAE1 (0.4)0
Serious AE9 (4.0)12 (5.5)
Severe TEAE6 (2.7)7 (3.2)
TEAE leading to discontinuation of study drug2 (0.9)5 (2.3)
Death00
Serious infections*2 (0.9)5 (2.3)
Active tuberculosis00
Herpes zoster01 (0.5)
Any other opportunistic infections00
Malignancy†1 (0.4)1 (0.5)
Anaphylactic reactions00
Injection site reactions3 (1.3)‡1 (0.5)
MACE1 (0.4)0
  • *Serious infections reported in the RZB group were abscess and cellulitis (one patient) and gastroenteritis (one patient); in the placebo group, serious infections were erysipelas, gastroenteritis, postoperative abscess, upper respiratory tract infection and urinary tract infection (each reported for one patient).

  • †Both were non-melanoma skin cancer.

  • ‡All were non-serious and did not result in discontinuation of the study drug.

  • AE, adverse event; MACE, major adverse cardiovascular event; PBO, placebo; RZB, risankizumab; TEAE, treatment-emergent adverse event.