Safety results
AE, n (%) | Placebo (n=67) | Lutikizumab (n=64) |
Any AE | 59 (88) | 58 (91) |
Any SAE | 2 (3) | 2 (3) |
AE leading to discontinuation | 2 (3) | 5 (8) |
Neutropaenia leading to discontinuation | 0 | 2 (3) |
Death | 0 | 0 |
Infection | 34 (51) | 26 (41) |
Serious infection | 0 | 0 |
Injection site reaction | 11 (16) | 23 (36) |
Laboratory abnormality, n (%) | ||
Neutropaenia (grade 2, 3 or 4) | 0 | 12 (19) |
Grade 2: 1 to <1.5 ×109/L | 0 | 9 (14) |
Grade 3: 0.5 to <1 ×109/L | 0 | 3 (5) |
Grade 4:<0.5 ×109/L | 0 | 0 |
Hypertriglyceridaemia (grade 3 or 4) | 0 | 1 (2) |
Grade 3: >5.7 to 11.4 mmol/L | 0 | 1 (2) |
Grades for laboratory abnormalities were defined by Common Toxicity Criteria.
AE, adverse event; SAE, serious adverse event.