Table 4.
Changes in selected laboratory analytes
| Placebo-controlled (to week 16) | All-bari-2-mg-AD | ||
|---|---|---|---|
| Placebo (N = 889) | Baricitinib 2 mg (N = 721) | All-bari-2-mg-AD (N = 1598) | |
| Creatinine phosphokinase | |||
| Increase to ≥ Grade 1 (> ULN and ≤ 2.5× ULN) | 84/783 (10.7) | 125/638 (19.6) | 314/1314 (23.9) |
| Increase to ≥ Grade 2 (> 2.5× ULN and ≤ 5× ULN) | 26/856 (3.0) | 33/697 (4.7) | 99/1492 (6.6) |
| Increase to ≥ Grade 3 (> 5× ULN and ≤ 10× ULN) | 16/865 (1.8) | 16/703 (2.3) | 48/1520 (3.2) |
| Increase to ≥ Grade 4 (> 10× ULN) | 10/869 (1.2) | 8/706 (1.1) | 26/1534 (1.7) |
| Hemoglobin | |||
| Increase to ≥ Grade 1 (< 7.27 mmol (Fe)/L [female]/8.18 mmol (Fe)/L [male] and ≥ 6.2 mmol (Fe)/L) | 38/818 (4.6) | 42/659 (6.4) | 104/1420 (7.3) |
| Increase to ≥ Grade 2 (< 6.2 mmol (Fe)/L and ≥ 4.9 mmol (Fe)/L) | 4/870 (0.5) | 3/706 (0.4) | 13/1540 (0.8) |
| Increase to ≥ Grade 3 (< 4.9 mmol (Fe)/L and ≥ 4.0 mmol (Fe)/L) | 0 | 0 | 0 |
| Neutrophils | |||
| Increase to ≥ Grade 3 (< 1.0 billion/L and ≥ 0.5 billion/L) | 0 | 1/707 (0.1) | 2/1542 (0.1) |
| Lymphocytes | |||
| Increase to ≥ Grade 3 (< 0.5 billion/L and ≥ 0.2 billion/L) | 2/868 (0.2) | 1/707 (0.1) | 8/1542 (0.5) |
| Platelets | |||
| Thrombocytosis ≤ 600 billions/L to > 600 billions/L | 0 | 8/706 (1.1) | 15/1538 (1.0) |
| LDL cholesterol | |||
| Increase to borderline high (≥ 3.36 mmol/L and < 4.14 mmol/L), high (≥ 4.14 mmol/L and < 4.91 mmol/L), or very high (≥ 4.91 mmol/L) | 41/643 (6.4) | 64/540 (11.9) | 229/1154 (19.8) |
| HDL cholesterol | |||
| Increase to high (≥ 1.55 mmol/L) | 73/524 (13.9) | 92/438 (21.0) | 254/921 (27.6) |
| Triglycerides | |||
| Increase to very high (≥ 5.65 mmol/L) | 8/789 (1.0) | 4/632 (0.6) | 12/1415 (0.8) |
| Alanine aminotransferase | |||
| ≥ 3× ULN | 9/872 (1.0) | 5/709 (0.7) | 26/1551 (1.7) |
| ≥ 5× ULN | 1/872 (0.1) | 1/709 (0.1) | 2/1551 (0.1) |
| ≥ 10× ULN | 0 | 0 | 1/1551 (0.1) |
| Aspartate aminotransferase | |||
| ≥ 3× ULN | 9/872 (1.0) | 5/709 (0.7) | 25/1551 (1.6) |
| ≥ 5× ULN | 5/872 (0.6) | 2/709 (0.3) | 11/1551 (0.7) |
| ≥ 10× ULN | 1/872 (0.1) | 0 | 0 |
Data are n/NAR (%)
Fe iron, HDL high-density lipoprotein, LDL low-density lipoprotein, N number of patients in the analysis set, n number of patients in the specified category, NAR number of patients at risk for the specified abnormality in each treatment group, ULN upper limit of normal