Upadacitinib 15 mg once daily, N=1417, PY=1243.3 | Adalimumab, N=579, PY=467.8 | |
Any AE | 266.4 (257.4 to 275.6) | 294.8 (279.4 to 310.8) |
Serious AE | 12.9 (11.0 to 15.1) | 15.6 (12.2 to 19.6) |
AE leading to discontinuation of study drug | 7.4 (6.0 to 9.1) | 11.1 (8.3 to 14.6) |
Infection | 86.8 (81.7 to 92.1) | 79.1 (71.2 to 87.6) |
Serious infection | 4.1 (3.1 to 5.4) | 4.3 (2.6 to 6.6) |
Opportunistic infection | 0.7 (0.3 to 1.4) | 0.6 (0.1 to 1.9) |
Herpes zoster | 3.1 (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) |
NMSC | 0.2 (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.