Table 4

Safety summary through week 24

Placebo
N=212
Upadacitinib 15 mg QD
N=211
Upadacitinib 30 mg QD
N=218
Patients with adverse events (AE), n (%)
Any AE139 (65.6)135 (64.0)170 (78.0)
Serious AE4 (1.9)12 (5.7)18 (8.3)
AE leading to discontinuation of trial drug11 (5.2)15 (7.1)20 (9.2)
Deaths1 (0.5)00
Infection73 (34.4)71 (33.6)108 (49.5)
 Serious infection1 (0.5)1 (0.5)6 (2.8)
 Opportunistic infection excl. tuberculosis and herpes zoster002 (0.9)
 Herpes zoster2 (0.9)3 (1.4)8 (3.7)
 Active tuberculosis000
Hepatic disorder3 (1.4)4 (1.9)18 (8.3)
Malignancy03 (1.4)3 (1.4)
 Non-melanoma skin cancer01 (0.5)1 (0.5)
 Malignancy other than NMSC02 (0.9)2 (0.9)
 Lymphoma*01 (0.5)0
Anaemia2 (0.9)4 (1.9)14 (6.4)
Neutropenia1 (0.5)2 (0.9)6 (2.8)
Lymphopenia02 (0.9)2 (0.9)
Creatine phosphokinase elevation4 (1.9)4 (1.9)12 (5.5)
Renal dysfunction1 (0.5)01 (0.5)
MACE (adjudicated)01 (0.5)0
VTE (adjudicated)01 (0.5)0
Laboratory data (LS mean change from baseline to week 24±SD)
Haemoglobin, g/L−0.7±7.44−3.6±9.45−5.5±10.78
Neutrophils, 109/L−0.056±1.6435−0.286±1.9578−0.610±2.0242
Lymphocytes, 109/L−0.076±0.5484−0.028±0.5460−0.057±0.5403
Platelets, 109/L1.7±59.358.4±51.5918.3±72.08
LDL-C, mmol/L0.003±0.68390.219±0.65670.453±0.9283
HDL-C, mmol/L−0.008±0.22780.199±0.25990.243±0.3451
ALT, U/L−0.7±10.286.8±16.059.1±16.45
AST, U/L−0.1±8.416.5±22.178.3±13.29
Creatinine, umol/L2.2±10.874.7±9.195.3±9.48
Creatine phosphokinase, U/L−19.9±140.87166.8±1198.70138.7±165.85
  • AEs were coded per the Medical Dictionary for Regulatory Activities. Laboratory data was graded using the Common Toxicity Criteria of the National Cancer Institute 4.03.

  • *In the once per day upadacitinib 15 mg arm, one event of treatment-emergent lymphocyte morphology abnormal was identified; per the investigator, no further diagnosis was made.

  • ALT, alanine aminotransferase; AST, aspartate aminotransferase; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; LS, least squares; MACE, major adverse cardiovascular events (defined as non-fatal myocardial infarction, non-fatal stroke and cardiovascular death); NMSC, non-melanoma skin cancer; QD, once per day; VTE, venous thromboembolic event (defined as deep vein thrombosis and pulmonary embolism).