Table 2

Grade 3 or 4 laboratory abnormalities through 264 weeks

ParameterAny UPA 15 mg QD
% of patients
Any ADA 40 mg EOW
% of patients
Haemoglobin (g/L)Grade 3 (decrease 21–29* or Hb ≥70 to <80)8.55.9
Grade 4 (decrease ≥30* or Hb <70)3.74.0
Lymphocytes (×109/L)Grade 3 (0.5 to <1.0)33.311.3
Grade 4 (<0.5)4.71.0
Neutrophils (×109/L)Grade 3 (0.5 to <1.0)1.80.9
Grade 4 (<0.5)0.40.3
ALT (U/L)Grade 3 (3.0–8.0×ULN)6.92.8
Grade 4 (>8.0×ULN)0.90.7
AST (U/L)Grade 3 (3.0–8.0×ULN)4.01.9
Grade 4 (>8.0×ULN)0.80.9
CPK (U/L)Grade 3 (>5.0–10.0×ULN)2.50.9
Grade 4 (>10.0×ULN)1.10.5
Creatinine (µmol/L)Grade 3 (>3.0–6.0×ULN)0.10.3
Grade 4 (>6.0×ULN)0.10
  • Safety was assessed up to week 264, through the cut-off date of 5 October 2022. Data are for patients with worsening in grade severity for laboratory parameters. Grading is based on Outcome Measures in Rheumatology criteria, except for CPK and creatinine, for which National Cancer Institute Common Terminology Criteria were used.

  • *Decrease from baseline. Baseline is defined as the last observation on or before the date of the first dose of study drug in the corresponding treatment group.

  • ADA, adalimumab; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CPK, creatine phosphokinase; EOW, every other week; Hb, Haemoglobin; QD, once daily; ULN, upper limit of normal; UPA, upadacitinib.