Table 2

Grade 3/4 laboratory abnormalities through week 156

Parameter, %UPA 15 mg QD
+MTX
ADA 40 mg EOW +MTX
Haemoglobin (g/dL)Grade 3 (decrease 2.1–2.9* or Hb ≥7.0 to <8.0)6.54.2
Grade 4 (decrease ≥3* or Hb <7.0)2.12.1
Lymphocytes (x109/L)Grade 3 (0.5 to <1.0)27.09.0
Grade 4 (<0.5)2.90.5
Neutrophils (x109/L)Grade 3 (0.5 to <1.0)1.30.5
Grade 4 (<0.5)0.40.3
ALT (U/L)Grade 3 (3.0–8.0 × ULN)5.42.1
Grade 4 (>8.0 × ULN)0.60.7
AST (U/L)Grade 3 (3.0–8.0 × ULN)3.31.4
Grade 4 (>8.0 × ULN)0.40.9
CPK (U/L)Grade 3 (>5.0 × ULN–10.0 × ULN)2.10.3
Grade 4 (>10.0 × ULN)0.70.3
Creatinine (μMol/L)Grade 3 (>3.0–6.0 × ULN)0.20.2
Grade 4 (>6.0 × ULN)0.10
  • Data are for patients with worsening in grade severity for laboratory parameters. Grading is based on Outcome Measures in Rheumatology (OMERACT) criteria, except for CPK and creatinine, where National Cancer Institute Common Terminology Criteria (NCI CTC) 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; MTX, methotrexate; QD, once daily; ULN, upper limit of normal; UPA, upadacitinib.