TABLE 1.
Baseline demographics and clinical characteristics
| Characteristic | 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) | |
| Age years | 70 (51–88) | 69 (52–84) | 70 (51–88) | 69 (52–85) | 69 (50–86) | 69 (50–86) |
| Male n (%) | 65 (83.3) | 63 (82.9) | 128 (83.1) | 137 (78.7) | 147 (83.1) | 284 (80.9) |
| White n (%) | 66 (84.6) | 60 (78.9) | 126 (81.8) | 151 (86.8) | 149 (84.2) | 300 (85.5) |
| Time since diagnosis years | 0.92 (0.1–5.0) | 1.53 (0.1–4.5) | 1.07 (0.1–5.0) | 1.51 (0.1–4.9) | 1.54 (0.1–5.1) | 1.54 (0.1–5.1) |
| FEV1/FVC ratio | 0.80 (0.6–0.9) | 0.81 (0.6–1.0) | 0.81 (0.6–1.0) | 0.81 (0.7–1.0) | 0.82 (0.7–1.0) | 0.82 (0.7–1.0) |
| FVC % predicted | 73.0 (38.0–98.8) | 72.8 (39.0–99.4) | 73.0 (38.0–99.4) | 71.5 (42.8–101.2) | 73.4 (39.7–98.3) | 72 (39.7–101.2) |
| DLCO % predicted | 41.7 (22.3–73.6) | 40.9 (25.0–67.9) | 41.1 (22.3–73.6) | 43.0 (12.9–71.3) | 43.0 (19.5–84.0) | 43.0 (12.9–84.0) |
| ATAQ-IPF total score# | 70.5 (34–114) | 69.0 (34–119) | 70.0 (34–119) | 71.0 (36–117) | 70.0 (34–118) | 70.0 (34–118) |
| HRCT UIP diagnosis n (%) | ||||||
| n | 78 | 75 | 153 | 174 | 177 | 348 |
| Definite UIP | 71 (91.0) | 70 (93.3) | 141 (92.6) | 142 (81.6) | 148 (83.6) | 287 (82.6) |
| Possible UIP | 7 (9.0) | 5 (6.7) | 12 (7.8) | 28 (16.1) | 28 (15.8) | 56 (16.0) |
| Inconsistent with UIP | 0 | 0 | 0 | 4 (2.3) | 1 (0.6) | 5 (1.4) |
| Surgical biopsy n (%) | ||||||
| n | 78 | 76 | 154 | 172 | 176 | 348 |
| Definite UIP | 31 (39.7) | 24 (31.6) | 55 (35.7) | 61 (35.5) | 54 (30.7) | 115 (33.0) |
| Probable UIP | 5 (6.4) | 11 (14.5) | 16 (10.4) | 17 (9.9) | 8 (4.5) | 25 (7.2) |
| Possible UIP | 0 | 0 | 0 | 0 | 0 | 0 |
| Not UIP | 0 | 0 | 0 | 0 | 0 | 0 |
| NA | 42 (53.8) | 41 (53.9) | 83 (53.9) | 94 (54.7) | 114 (64.8) | 208 (59.8) |
Data are presented as median (range), unless otherwise stated. All values are from measurements at baseline visit (day of randomisation); eligibility was based on measurements at screening visit. #: range is 31–124. ATAQ-IPF: A Tool to Assess Quality of Life in IPF; DLCO: diffusing capacity of the lungs for carbon monoxide; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; HRCT: high-resolution computed tomography; UIP: usual interstitial pneumonia.