Group A# | Group B¶ | Group C+ | ||||
Nintedanib | Placebo | Nintedanib | Placebo | Nintedanib | Placebo | |
Subjects, n | 160 | 172 | 110 | 97 | 62 | 61 |
Male | 81 (50.6) | 85 (49.4) | 66 (60.0) | 53 (54.6) | 32 (51.6) | 38 (62.3) |
Age, years | 66.5±9.0 | 67.2±9.1 | 64.8±9.6 | 66.0±9.3 | 62.8±11.2 | 64.1±12.1 |
Body mass index, kg·m−2 | 27.9±5.2 | 28.0±5.5 | 28.1±4.8 | 28.9±5.8 | 28.8±5.1 | 28.8±5.1 |
ILD diagnosis | ||||||
Hypersensitivity pneumonitis | 44 (27.5) | 51 (29.7) | 24 (21.8) | 27 (27.8) | 16 (25.8) | 11 (18.0) |
Autoimmune ILDs§ | 43 (26.9) | 42 (24.4) | 26 (23.6) | 31 (32.0) | 13 (21.0) | 15 (24.6) |
Idiopathic NSIP | 30 (18.8) | 32 (18.6) | 16 (14.5) | 16 (16.5) | 18 (29.0) | 13 (21.3) |
Unclassifiable IIP | 30 (18.8) | 25 (14.5) | 26 (23.6) | 14 (14.4) | 8 (12.9) | 11 (18.0) |
Other ILDsƒ | 13 (8.1) | 22 (12.8) | 18 (16.4) | 9 (9.3) | 7 (11.3) | 11 (18.0) |
UIP-like fibrotic pattern on HRCT | 100 (62.5) | 98 (57.0) | 76 (69.1) | 68 (70.1) | 30 (48.4) | 39 (63.9) |
FVC, mL | 2210±706 | 2121±633 | 2452±705 | 2487±752 | 2477±837 | 2601±772 |
FVC % predicted | 66.5±14.8 | 65.6±12.7 | 70.0±16.3 | 73.4±16.8 | 72.1±17.9 | 73.0±16.8 |
DLCO % predicted | 44.8±12.3 | 45.1±13.2 | 43.5±11.7 | 51.8±15.4 | 44.7±11.6 | 49.5±17.4 |
Data are presented as n (%) or mean±sd, unless otherwise stated. ILD: interstitial lung disease; NSIP: nonspecific interstitial pneumonia; IIP: idiopathic interstitial pneumonia; UIP: usual interstitial pneumonia; HRCT: high-resolution computed tomography; FVC: forced vital capacity; DLCO: diffusing capacity of the lung for carbon monoxide. #: decline in FVC ≥10% predicted; ¶: decline in FVC ≥5–<10% predicted with worsened respiratory symptoms and/or increased extent of fibrosis on HRCT; +: worsened respiratory symptoms and increased extent of fibrosis on HRCT only; §: included rheumatoid arthritis-associated ILD, systemic sclerosis-associated ILD and mixed connective tissue disease-associated ILD, plus subjects with an autoimmune disease noted in the “Other fibrosing ILDs” category of case report form; ƒ: included sarcoidosis, exposure-related ILDs and selected terms in the “Other fibrosing ILDs” category of case report form.