Table 5

Summary of laboratory abnormalities of special interest through weeks 12 and 24

Weeks 0–12Weeks 0–24
BaricitinibBaricitinib
Placebo once daily (N=98)1 mg once daily (N=49)2 mg once daily (N=52)4 mg once daily (N=52)8 mg once daily (N=50)2 mg once daily (N=52)4 mg once daily (N=52)8 mg once daily (N=50)
Decreased neutrophils, n (%)
 Grade 1:≥1500 cells/mm3 to less than LLN*3 (3)4 (8)3 (6)2 (4)6 (12)4 (8)1 (2)5 (10)
 Grade 2:≥1000 to <1500 cells/mm31 (1)1 (2)1 (2)2 (4)5 (10)3 (6)5 (10)9 (18)
 Grade 3:≥500 to <1000 cells/mm3001 (2)01 (2)1 (2)01 (2)
Decreased lymphocytes, n (%)
 Grade 1:≥800 cells/mm3 to less than LLN13 (13)6 (12)5 (10)9 (18)6 (12)6 (12)10 (20)10 (20)
 Grade 2:≥500 to <800 cells/mm33 (3)2 (4)4 (8)3 (6)5 (10)5 (10)7 (14)10 (20)
Decreased haemoglobin, n (%)
 Grade 1:≥10.0 g/dL to less than LLN29 (30)17 (35)11 (21)11 (22)21 (42)14 (27)17 (33)23 (46)
 Grade 2:≥8.0 to <10.0 g/dL5 (5)03 (6)6 (12)4 (8)4 (8)6 (12)6 (12)
Elevated platelets, n (%)
Platelet count >600 000 cells/µL†1 (1)1 (2)02 (4)002 (4)0
Elevated ALT, n (%)
 Grade 1:>ULN and ≤2.5× ULN19 (19)10 (20)9 (17)11 (22)10 (20)11 (21)14 (27)13 (26)
 Grade 2:>2.5× ULN and ≤5× ULN3 (3)02 (4)2 (4)02 (4)3 (6)1 (2)
 Grade 3:>5× ULN and ≤20× ULN0001 (2)1 (2)01 (2)1 (2)
  • *Laboratory grades defined using Common Terminology Criteria for Adverse Events V.4.0. Grades are based on the worst single value through the time period.

  • †Incidence of protocol-defined thrombocytosis in patients with platelet counts >600 000 cells/µL.

  • ALT, alanine aminotransferase; LLN, lower limit of normal; N, number of patients randomised and treated; n, number of patients with laboratory abnormality; ULN, upper limit of normal.