Weeks 0–12 | Weeks 0–24 | |||||||
---|---|---|---|---|---|---|---|---|
Baricitinib | Baricitinib | |||||||
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/mm3 | 1 (1) | 1 (2) | 1 (2) | 2 (4) | 5 (10) | 3 (6) | 5 (10) | 9 (18) |
Grade 3:≥500 to <1000 cells/mm3 | 0 | 0 | 1 (2) | 0 | 1 (2) | 1 (2) | 0 | 1 (2) |
Decreased lymphocytes, n (%) | ||||||||
Grade 1:≥800 cells/mm3 to less than LLN | 13 (13) | 6 (12) | 5 (10) | 9 (18) | 6 (12) | 6 (12) | 10 (20) | 10 (20) |
Grade 2:≥500 to <800 cells/mm3 | 3 (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 LLN | 29 (30) | 17 (35) | 11 (21) | 11 (22) | 21 (42) | 14 (27) | 17 (33) | 23 (46) |
Grade 2:≥8.0 to <10.0 g/dL | 5 (5) | 0 | 3 (6) | 6 (12) | 4 (8) | 4 (8) | 6 (12) | 6 (12) |
Elevated platelets, n (%) | ||||||||
Platelet count >600 000 cells/µL† | 1 (1) | 1 (2) | 0 | 2 (4) | 0 | 0 | 2 (4) | 0 |
Elevated ALT, n (%) | ||||||||
Grade 1:>ULN and ≤2.5× ULN | 19 (19) | 10 (20) | 9 (17) | 11 (22) | 10 (20) | 11 (21) | 14 (27) | 13 (26) |
Grade 2:>2.5× ULN and ≤5× ULN | 3 (3) | 0 | 2 (4) | 2 (4) | 0 | 2 (4) | 3 (6) | 1 (2) |
Grade 3:>5× ULN and ≤20× ULN | 0 | 0 | 0 | 1 (2) | 1 (2) | 0 | 1 (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.