Table 2.
Patients with worsening in grade severity (grades 3 or 4) for laboratory parameters at any time during 84 weeks, including single isolated values (safety analysis set)
| Lab parameter† n (%) | Upadacitinib 7.5 mg QD (n = 65) | Upadacitinib 15 mg QD (n = 64) | Upadacitinib 30 mg QD (n = 66) |
|---|---|---|---|
| Hemoglobin (g/L) | |||
| Grade 3 (70 to < 80 or ↓ 21 to < 30) | 0 | 1 (1.6) | 9 (13.6) |
| Grade 4 (< 70 or ↓ ≥ 30) | 1 (1.5) | 0 | 4 (6.1) |
| Lymphocytes (× 109/L) | |||
| Grade 3 (0.5 to < 1.0) | 30 (46.2) | 27 (42.2) | 36 (54.5) |
| Grade 4 (< 0.5) | 4 (6.2) | 2 (3.1) | 4 (6.1) |
| Neutrophils (× 109/L) | |||
| Grade 3 (0.5 to < 1.0) | 1 (1.5) | 1 (1.6) | 2 (3.0) |
| Grade 4 (< 0.5) | 1 (1.5) | 0 | 0 |
| Leukocytes (× 109/L) | |||
| Grade 3 (1.0 to < 2.0) | 1 (1.5) | 0 | 1 (1.5) |
| Grade 4 (< 1.0) | 0 | 0 | 0 |
| ALT (U/L) | |||
| Grade 3 (3.0–8.0 × ULN) | 1 (1.5) | 3 (4.7) | 2 (3.0) |
| Grade 4 (> 8.0 × ULN) | 0 | 0 | 1 (1.5) |
| AST (U/L) | |||
| Grade 3 (3.0–8.0 × ULN) | 1 (1.5) | 2 (3.1) | 2 (3.0) |
| Grade 4 (> 8.0 × ULN) | 0 | 0 | 0 |
| CPK (U/L) | |||
| Grade 3 (> 5–10 × ULN) | 2 (3.1) | 2 (3.1) | 3 (4.5) |
| Grade 4 (> 10 × ULN) | 0 | 1 (1.6) | 4 (6.1) |
| Creatinine (μmol/L) | |||
| Grade 3 (> 3.0–6.0 × ULN) | 0 | 0 | 0 |
| Grade 4 (> 6.0 × ULN) | 0 | 0 | 0 |
Two subjects treated with placebo in period 1 discontinued treatment and thus were not included in the safety analysis set. Notes: For CPK and creatinine, NCI-CTC criteria were used. Post-baseline grade must be higher than the baseline grade
ALT alanine aminotransferase, AST aspartate aminotransferase, CPK creatine phosphokinase, NCI-CTC National Cancer Institute Common Toxicity Criteria, OMERACT Outcome Measures in Rheumatology, QD once daily, ULN upper limit of normal
†The toxicity grading is based on OMERACT criteria (Rheumatology Common Toxicity Criteria v.2.0)