Table 4.
Laboratory values through week 52 (safety population)
| Sarilumab | ||||
|---|---|---|---|---|
| Placebo + MTX to 150 mg q2w (n = 14) |
Placebo + MTX to 200 mg q2w (n = 15) |
150 mg q2w + MTX (n = 81) |
200 mg q2w + MTX (n = 80) |
|
| Absolute neutrophil count, n (%) | ||||
| Grade 1: ≥ 1.5 Giga/l to < LLN | 3 (21.4) | 2 (13.3) | 14 (17.3) | 19 (23.8) |
| Grade 2: ≥ 1 to < 1.5 Giga/l | 2 (14.3) | 6 (40.0) | 20 (24.7) | 18 (22.5) |
| Grade 3: ≥ 0.5 to < 1 Giga/l | 2 (14.3) | 0 | 10 (12.3) | 6 (7.5) |
| Grade 4: < 0.5 Giga/l | 1 (7.1) | 0 | 1 (1.2) | 0 |
| Hepatic enzyme levels, n (%) | ||||
| ALT | ||||
| > 1 ULN and ≤ 3 ULN | 7 (50.0) | 10 (66.7) | 41 (50.6) | 43 (53.8) |
| > 3 ULN and ≤ 5 ULN | 2 (14.3) | 0 | 11 (13.6) | 5 (6.3) |
| > 5 ULN and ≤ 10 ULN | 0 | 1 (6.7) | 1 (1.2) | 2 (2.5) |
| > 10 ULN | 0 | 0 | 0 | 0 |
| AST | ||||
| > 1 ULN and ≤ 3 ULN | 9 (64.3) | 9 (60.0) | 52 (64.2) | 42 (52.5) |
| > 3 ULN and ≤ 5 ULN | 1 (7.1) | 1 (6.7) | 5 (6.2) | 2 (2.5) |
| > 5 ULN and ≤ 10 ULN | 0 | 0 | 0 | 1 (1.3) |
| > 10 ULN | 0 | 0 | 0 | 0 |
The number (n) represents the subset of the total number of patients who met the criterion in question at least once during treatment-emergent adverse event period
ALT alanine aminotransferase, AST aspartate aminotransferase, LLN lower limit of normal, MTX methotrexate, q2w every 2 weeks, ULN upper limit of normal