Table 3

EAERs of malignancy (excluding NMSC), adjudicated MACE and VTE through 264 weeks

EAERContinuous UPA 15 mg QD
(n=398; PY=1573.0)
E (E/100 PY)(95% CI)
Continuous ADA 40 mg EOW (n=168; PY=582.4)
E (E/100 PY) (95% CI)
Malignancy (excluding NMSC)12 (0.8) (0.4 to 1.3)5 (0.9) (0.3 to 2.0)
Adjudicated MACE*2 (0.1) (0.0 to 0.5)2 (0.3) (0.0 to 1.2)
Adjudicated VTE†3 (0.2) (0.0 to 0.6)3 (0.5) (0.1 to 1.5)
  • Safety was assessed up to week 264, through the cut-off date of 5 October 2022.

  • *MACE defined as cardiovascular death (includes acute MI, sudden cardiac death, heart failure, cardiovascular procedure-related death, death due to cardiovascular haemorrhage, fatal stroke, pulmonary embolism and other cardiovascular causes), non-fatal MI and non-fatal stroke.

  • †VTE included fatal and non-fatal deep vein thrombosis and pulmonary embolism.

  • ADA, adalimumab; E, events; EAER, exposure-adjusted event rate; EOW, every other week; MACE, major adverse cardiovascular event; MI, myocardial infarction; NMSC, non-melanoma skin cancer; PY, patient-years; QD, once daily; UPA, upadacitinib; VTE, venous thromboembolic event.