AE, n (%) | Placebo (n=79) | Mavrilimumab | ||||
---|---|---|---|---|---|---|
10 mg (n=39) | 30 mg (n=41) | 50 mg (n=40) | 100 mg (n=40) | Total (n=160) | ||
Total number of AEs | 74 | 39 | 40 | 37 | 29 | 145 |
Total subjects reporting ≥1 AE | 36 (45.6) | 25 (64.1) | 24 (58.5) | 19 (47.5) | 23 (57.5) | 91 (56.9) |
Carbon monoxide diffusing capacity decreased | 5 (6.3) | 10 (25.6) | 3 (7.3) | 3 (7.5) | 3 (7.5) | 19 (11.9) |
Nasopharyngitis | 2 (2.5) | 1 (2.6) | 4 (9.8) | 1 (2.5) | 4 (10.0) | 10 (6.3) |
Upper respiratory tract infection | 4 (5.1) | 2 (5.1) | 1 (2.4) | 1 (2.5) | 2 (5.0) | 6 (3.8) |
Worsening of rheumatoid arthritis | 2 (2.5) | 2 (5.1) | 1 (2.4) | 2 (5.0) | 0 (0) | 5 (3.1) |
Transaminases increased | 0 (0) | 1 (2.6) | 1 (2.4) | 1 (2.5) | 1 (2.5) | 4 (2.5) |
Alanine aminotransferase increased | 0 (0) | 0 (0) | 2 (4.9) | 1 (2.5) | 1 (2.5) | 4 (2.5) |
Pharyngitis | 0 (0) | 0 (0) | 1 (2.4) | 2 (5.0) | 1 (2.5) | 4 (2.5) |
Oral herpes | 0 (0) | 1 (2.6) | 2 (4.9) | 0 (0) | 0 (0) | 3 (1.9) |
Hypercholesterolemia | 1 (1.3) | 1 (2.6) | 1 (2.4) | 1 (2.5) | 0 (0) | 3 (1.9) |
Neutropenia | 0 (0) | 0 (0) | 2 (4.9) | 1 (2.5) | 0 (0) | 3 (1.9) |
Influenza | 1 (1.3) | 1 (2.6) | 0 (0) | 2 (5.0) | 0 (0) | 3 (1.9) |
Hepatic enzyme increased | 2 (2.5) | 1 (2.6) | 0 (0) | 0 (0) | 1 (2.5) | 2 (1.3) |
Injection site pain | 0 (0) | 0 (0) | 1 (2.4) | 0 (0) | 1 (2.5) | 2 (1.3) |
Anemia | 4 (5.1) | 1 (2.6) | 0 (0) | 0 (0) | 1 (2.5) | 2 (1.3) |
Bronchitis | 1 (1.3) | 0 (0) | 0 (0) | 0 (0) | 2 (5.0) | 2 (1.3) |
Amenorrhea | 0 (0) | 1 (2.6) | 0 (0) | 0 (0) | 1 (2.5) | 2 (1.3) |
Skin exfoliation | 0 (0) | 1 (2.6) | 0 (0) | 1 (2.5) | 0 (0) | 2 (1.3) |
Monocytopenia | 2 (2.5) | 0 (0) | 0 (0) | 0 (0) | 1 (2.5) | 1 (0.6) |
Hypertension | 2 (2.5) | 0 (0) | 1 (2.4) | 0 (0) | 0 (0) | 1 (0.6) |
Rash | 2 (2.5) | 0 (0) | 1 (2.4) | 0 (0) | 0 (0) | 1 (0.6) |
Cough | 2 (2.5) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Treatment-related adverse events | ||||||
Total subjects reporting ≥1 related AE | 11 (13.9) | 8 (20.5) | 9 (22.0) | 8 (20.0) | 7 (17.5) | 32 (20.0) |
Carbon monoxide diffusing capacity decreased | 1 (1.3) | 4 (10.3) | 2 (4.9) | 1 (2.5) | 0 (0) | 7 (4.4) |
Upper respiratory tract infection | 1 (1.3) | 0 (0) | 0 (0) | 1 (2.5) | 2 (5.0) | 3 (1.9) |
Neutropenia | 0 (0) | 0 (0) | 2 (4.9) | 1 (2.5) | 0 (0) | 3 (1.9) |
Worsening of rheumatoid arthritis | 0 (0) | 0 (0) | 1 (2.4) | 1 (2.5) | 0 (0) | 2 (1.3) |
Transaminases increased | 0 (0) | 0 (0) | 0 (0) | 1 (2.5) | 1 (2.5) | 2 (1.3) |
Hepatic enzyme increased | 2 (2.5) | 1 (2.6) | 0 (0) | 1 (2.5) | 0 (0) | 1 (0.6) |
Serious adverse events | ||||||
Total subjects reporting ≥1 related SAE | 1 | 2 | 2 | 0 | 0 | 0 |
AE, adverse event; SAE, serious adverse event.