Table 1

TEAEs through 264 weeks

EAERAny UPA 15 mg QD (n=1417; PY=4496.6)
E (E/100 PY)
Any ADA 40 mg EOW (n=579; PY=1472.4)
E (E/100 PY)
Any TEAE8419 (187.2)2978 (202.3)
Serious TEAE517 (11.5)196 (13.3)
TEAE leading to discontinuation of study drug195 (4.3)81 (5.5)
Any COVID-19-related adverse event239 (5.3)62 (4.2)
Any death*41 (0.9)14 (1.0)
TEAEs of special interest
 Serious infection167 (3.7)49 (3.3)
 Opportunistic infection†13 (0.3)2 (0.1)
 Herpes zoster127 (2.8)17 (1.2)
 Active tuberculosis3 (<0.1)3 (0.2)
 Malignancy (excluding NMSC)26 (0.6)12 (0.8)
 NMSC24 (0.5)2 (0.1)
 Lymphoma03 (0.2)
 Adjudicated MACE‡12 (0.3)4 (0.3)
 Adjudicated VTE§12 (0.3)6 (0.4)
 Adjudicated gastrointestinal perforation1 (<0.1)0
 Renal dysfunction12 (0.3)6 (0.4)
 Anaemia113 (2.5)49 (3.3)
 Lymphopenia115 (2.6)13 (0.9)
 Neutropenia95 (2.1)34 (2.3)
 CPK elevation179 (4.0)26 (1.8)
 Hepatic disorder476 (10.6)101 (6.9)
  • Safety was assessed up to week 264, through the cut-off date of 5 October 2022. TEAEs included any adverse event with an onset date on or after the first dose of study drug and up to 30 days after the last dose of placebo or UPA and 70 days for ADA, if patients discontinued prematurely. Data through 264 weeks include all patients receiving UPA or ADA, including rescue groups, with assignment based on drug exposure at the time of the event.

  • *Includes treatment emergent (occurring ≤30 days after the last dose of UPA or ≤70 days after the last dose of ADA) and non-treatment-emergent (occurring >30 days after the last dose of UPA or >70 days after the last dose of ADA) deaths.

  • †Excluding herpes zoster and tuberculosis.

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

  • §VTE included deep vein thrombosis and pulmonary embolism (fatal and non-fatal).

  • ADA, adalimumab; CPK, creatine phosphokinase; E, Event; EAER, exposure-adjusted event rate; EOW, every other week; MACE, major adverse cardiovascular event; NMSC, non-melanoma skin cancer; PY, patient-years; QD, once daily; TEAE, treatment-emergent adverse event; UPA, upadacitinib; VTE, venous thromboembolic event.