Table 4

Safety in patients with GCA

(N=65)
Patients with ≥1 AE48 (73.8)
Total no of non-serious AEs121
 Related or possibly related to prednisone exclusively*23 (19.0)
 Related or possibly related to TCZ exclusively*48 (39.7)
 Related or possibly related to prednisone or TCZ*9 (7.4)
Patients with ≥1 SAE11 (16.9)
Total no of SAEs13
 Related or possibly related to prednisone exclusively†3 (23.1)
  Diabetic ketoacidosis1
  Stroke1
  Vertebral fracture1
 Related or possibly related to TCZ exclusively†4 (30.8)
  Bacteraemia of unclear source1
  COVID-191
  Diverticulitis1
  Postsurgical skin and soft-tissue infection1
 Related or possibly related to prednisone or TCZ†2 (15.4)
  Pneumonia1
  Sepsis from urinary tract infection1
  • All values represent number (%).

  • *The denominator for the AE proportions is 121 total AEs.

  • †The denominator for the SAE proportions is 13 total SAEs.

  • AE, adverse event; GCA, giant cell arteritis; SAE, serious adverse event; TCZ, tocilizumab.