TABLE 3.
Overview of safety during the placebo-controlled period
| Event | Cohort A¶ | Cohort B | ||||
| Lebrikizumab (n=78) | Placebo (n=76) | All patients (N=154) | Lebrikizumab+pirfenidone (n=174) | Placebo+pirfenidone (n=177) | All patients (N=351) | |
| Patients with ≥1 AE | 75 (96.2) | 71 (93.4) | 146 (94.8) | 158 (90.8) | 171 (96.6) | 329 (93.7) |
| Total AEs | 531 | 446 | 977 | 1013 | 1052 | 2065 |
| Deaths | 3 (3.8) | 3 (3.9) | 6 (3.9) | 5 (2.9) | 10 (5.6) | 15 (4.3) |
| Patients withdrawn from study due to AE | 5 (6.4) | 9 (11.8) | 14 (9.1) | 16 (9.2) | 27 (15.3) | 43 (12.3) |
| Patients with ≥1 AE with fatal outcome | 3 (3.8) | 3 (3.9) | 6 (3.9) | 9 (5.2) | 13 (7.3) | 22 (6.3) |
| Patients with ≥1 SAE | 23 (29.5) | 19 (25.0) | 42 (27.3) | 56 (32.2) | 47 (26.6) | 103 (29.3) |
| Patients with ≥1 SAE leading to withdrawal from treatment | 6 (7.7) | 6 (7.9) | 12 (7.8) | 12 (6.9) | 14 (7.9) | 26 (7.4) |
| Patients with ≥1 SAE leading to dose modification/interruption | 5 (6.4) | 3 (3.9) | 8 (5.2) | 6 (3.4) | 4 (2.3) | 10 (2.8) |
| Patients with ≥1 treatment-related SAE | 2 (2.6) | 1 (1.3) | 3 (1.9) | 3 (1.7) | 6 (3.4) | 9 (2.6) |
| Patients with ≥1 AE leading to withdrawal from treatment | 8 (10.3) | 9 (11.8) | 17 (11.0) | 20 (11.5) | 26 (14.7) | 46 (13.1) |
| Patients with ≥1 AE leading to dose modification/interruption | 7 (9.0) | 5 (6.6) | 12 (7.8) | 11 (6.3) | 11 (6.2) | 22 (6.3) |
| Patients with ≥1 treatment-related AE | 25 (32.1) | 19 (25.0) | 44 (28.6) | 30 (17.2) | 30 (16.9) | 60 (17.1) |
| Patients with ≥1 treatment-related AE leading to withdrawal from treatment | 0 | 2 (2.6) | 2 (1.3) | 3 (1.7) | 8 (4.5) | 11 (3.1) |
| Patients with ≥1 treatment-related AE leading to dose modification/interruption | 2 (2.6) | 0 | 2 (1.3) | 1 (0.6) | 1 (0.6) | 2 (0.6) |
| AESIs | ||||||
| Injection-site reactions | 13 (16.7) | 6 (7.9) | 19 (12.3) | 5 (2.9) | 5 (2.8) | 10 (2.8) |
| Infections (broad) | 51 (65.4) | 41 (53.9) | 92 (59.7) | 106 (60.9) | 114 (64.4) | 220 (62.7) |
| Infections (narrow) | 0 | 0 | 0 | 0 | 1 (0.6) | 1 (0.3) |
| Malignancies# | 5 (6.4) | 2 (2.6) | 7 (4.5) | 13 (7.5) | 12 (6.8) | 25 (7.1) |
| AEs related to pirfenidone | 5 (6.4) | 3 (3.9) | 8 (5.2) | 64 (36.8) | 70 (39.5) | 134 (38.2) |
| AEs leading to withdrawal from pirfenidone | 1 (1.3) | 1 (1.3) | 2 (1.3) | 9 (5.2) | 12 (6.8) | 21 (6.0) |
Data are presented as n (%) or n. AE: adverse event; AESI: adverse event of special interest; NA: not available; SAE: serious adverse event. #: Identified with Standardised Medical Dictionary for Regulatory Activities (MedDRA) Queries “narrow”; ¶: patients were not required to stop study drug to be treated with pirfenidone.