Changes in selected laboratory values and clinical chemistry
| n/NAR (%) | Placebo controlled | Extended | All-Bari-SLE (N=1655) | |||
| Placebo (N=635) | Bari 2 mg (N=641) | Bari 4 mg (N=634) | Bari 2 mg (N=641) | Bari 4 mg (N=634) | ||
| Anaemia (haemoglobin <80 g/L) | 5/629 (0.8) | 7/640 (1.1) | 1/630 (0.2) | 12/640 (1.9) | 6/630 (1.0) | 24/1643 (1.5) |
| Neutrophils (<1.0 billion/L) | 23/625 (3.7) | 19/633 (3.0) | 40/629 (6.4) | 28/633 (4.4) | 46/629 (7.3) | 84/1622 (5.2) |
| Lymphocytes (<0.5 billion/L) | 69/585 (11.8) | 68/594 (11.4) | 69/592 (11.7) | 87/594 (14.6) | 87/592 (14.7) | 187/1500 (12.5) |
| Thrombocytosis (platelets >600 ×109/L) | 2/626 (0.3) | 4/638 (0.6) | 15/629 (2.4) | 5/638 (0.5) | 16/629 (2.5) | 24/1639 (1.5) |
| ALT≥3×ULN | 17/629 (2.7) | 25/640 (3.9) | 19/632 (3.0) | 30/640 (4.7) | 26/632 (4.1) | 61/1649 (3.7) |
| AST≥3×ULN | 12/629 (1.9) | 16/640 (2.5) | 19/632 (3.0) | 21/640 (3.3) | 28/632 (4.4) | 52/1649 (3.2) |
| TBL≥2×ULN | 0/629 | 0/640 | 0/632 | 0/640 | 0/632 | 1/1649 (0.1) |
| ALP≥1.5×ULN | 20/620 (3.2) | 21/640 (3.3) | 8/632 (1.3) | 26/640 (4.1) | 15/632 (2.4) | 49/1649 (3.0) |
| CPK | ||||||
| >ULN and ≤2.5×ULN | 76/590 (12.9) | 147/603 (24.4) | 182/594 (30.6) | 179/602 (29.7) | 212/594 (35.7) | 441/1496 (29.5) |
| >2.5 ULN and ≤5×ULN | 22/622 (3.5) | 36/631 (5.7) | 47/628 (7.5) | 42/630 (6.7) | 61/628 (9.7) | 112/1612 (6.9) |
| >5×ULN | 12/627 (1.9) | 13/635 (2.0) | 15/631 (2.4) | 16/634 (2.5) | 21/631 (3.3) | 39/1632 (2.4) |
| LDL≥130 mg/dL* | 71/488 (14.5) | 115/486 (23.7) | 109/488 (22.3) | 142/486 (29.2) | 138/488 (28.3) | 328/1238 (26.5) |
| HDL<40 mg/dL† | 69/493 (14.0) | 41/484 (8.5) | 30/474 (6.3) | 56/484 (11.6) | 43/474 (9.1) | 112/1233 (9.1) |
| Triglycerides ≥500 mg/dL‡ | 2/563 (0.4) | 3/581 (0.5) | 4/564 (0.7) | 7/581 (1.2) | 7/564 (1.2) | 16/1505 (1.1) |
Percentages are based on number of patients at risk for specified anomaly.
*Increase to borderline high, high or very high (NCEP criteria).
†Decrease to low (NCEP criteria).
‡Increase to very high (NCEP criteria).
ALP, alkaline phosphatase; ALT, alanine transaminase; AST, aspartate transaminase; bari, baricitinib; CPK, creatine phosphokinase; HDL, high-density lipoprotein; LDL, low-density lipoprotein; n, number of patients in the specified category; N, number of patients in the analysis; NCEP, National Cholesterol Education Programme; SLE, systemic lupus erythematosus; TBL, total bilirubin; ULN, upper limit of normal.