Table 5.
Adverse events (AEs) reported during the entire study
| Patients experiencing ≥1 event | Placebo (n=116) | Lebrikizumab 37.5 mg (n=117) | Lebrikizumab 125 mg (n=112) | Lebrikizumab 250 mg (n=118) |
|---|---|---|---|---|
| Any AE | 81 (69.8) | 87 (74.4) | 90 (80.4) | 87 (73.7) |
| Any serious AE | 7 (6.0) | 1 (0.9) | 6 (5.4) | 7 (5.9) |
| Severe AE | 14 (12.1) | 14 (12.0) | 9 (8.0) | 11 (9.3) |
| Most common AEs (>5% in any treatment group) | ||||
| Asthma | 33 (28.4) | 26 (22.2) | 29 (25.9) | 33 (28.0) |
| Upper respiratory tract infection | 13 (11.2) | 17 (14.5) | 26 (23.2) | 18 (15.3) |
| Nasopharyngitis | 15 (12.9) | 7 (6.0) | 13 (11.6) | 13 (11.0) |
| Sinusitis | 12 (10.3) | 10 (8.5) | 12 (10.7) | 7 (5.9) |
| Bronchitis | 8 (6.9) | 6 (5.1) | 9 (8.0) | 9 (7.6) |
| Injection site erythema | 2 (1.7) | 3 (2.6) | 9 (8.0) | 12 (10.2) |
| Acute sinusitis | 7 (6.0) | 1 (0.9) | 7 (6.3) | 9 (7.6) |
| Influenza | 5 (4.3) | 3 (2.6) | 7 (6.3) | 6 (5.1) |
| Injection site pain | 4 (3.4) | 4 (3.4) | 8 (7.1) | 4 (3.4) |
| Back pain | 8 (6.9) | 4 (3.4) | 3 (2.7) | 4 (3.4) |
| Cough | 6 (5.2) | 4 (3.4) | 2 (1.8) | 4 (3.4) |
| Arthralgia | 3 (2.6) | 2 (1.7) | 6 (5.4) | 3 (2.5) |
| Vomiting | 2 (1.7) | 2 (1.7) | 1 (0.9) | 6 (5.1) |
| Erythema | 1 (0.9) | 2 (1.7) | 7 (6.3) | 0 |
| AEs of interest | ||||
| Any ISR | 7 (6.0) | 13 (11.1) | 23 (20.5) | 24 (20.3) |
| Hypersensitivity reactions (broad*) | 2 (1.7) | 0 | 1 (0.9) | 1 (0.8) |
| All infections | 62 (53.4) | 54 (46.2) | 68 (60.7) | 60 (50.8) |
| Neoplasms | 1 (0.9) | 2 (1.7) | 1 (0.9) | 2 (1.7) |
*Broad search using Anaphylaxis Standardised MedDRA Query (SMQ) as algorithm (based on applying Sampson's criteria as a bucket of search terms) plus the term hypersensitivity. These cases were all cases of hypersensitivity that did not meet criteria for anaphylaxis and none were serious hypersensitivity.
ISR, injection site reaction.