Table 2

Exposure adjusted event rates for TEAE (E/100 PYs (95% CI))

Upadacitinib 15 mg once daily, N=1417, PY=1243.3Adalimumab, N=579, PY=467.8
Any AE266.4 (257.4 to 275.6)294.8 (279.4 to 310.8)
Serious AE12.9 (11.0 to 15.1)15.6 (12.2 to 19.6)
AE leading to discontinuation of study drug7.4 (6.0 to 9.1)11.1 (8.3 to 14.6)
Infection86.8 (81.7 to 92.1)79.1 (71.2 to 87.6)
 Serious infection4.1 (3.1 to 5.4)4.3 (2.6 to 6.6)
 Opportunistic infection0.7 (0.3 to 1.4)0.6 (0.1 to 1.9)
 Herpes zoster3.1 (2.2 to 4.2)1.3 (0.5 to 2.8)
Hepatic disorder*17.7 (15.4 to 20.2)13.9 (10.7 to 17.7)
Gastrointestinal perforation†0.2 (0 to 0.7)0
Any malignancy (excluding NMSC)0.4 (0.1 to 0.9)0.6 (0.1 to 1.9)
NMSC0.2 (0 to 0.7)0.2 (0 to 1.2)
MACE (adjudicated)‡0.4 (0.1 to 0.9)0.4 (0.1 to 1.5)
Venous thromboembolic events (adjudicated)‡0.3 (0.1 to 0.8)1.1 (0.3 to 2.5)
Deaths‡§0.4 (0.1 to 0.9)0.9 (0.2 to 2.2)
  • *Hepatic disorders: majority were based on asymptomatic alanine aminotransferase/aspartate aminotransferase elevations.

  • †Gastrointestinal perforations were identified through Standardised Medical Dictionary for Regulatory Activities query.

  • ‡Exposure-adjusted incidence rates.

  • §Deaths included non-treatment emergent deaths.

  • AE, adverse event; MACE, major adverse cardiovascular event; NMSC, non-melanoma skin cancer; PYs, patient years;TEAE, treatment-emergent adverse events.