Table 2.
Characteristic | TOMORROW (IPF) n = 342a |
INPULSIS-1 (IPF) n = 513 |
INPULSIS-2 (IPF) n = 548 |
SENSCIS (SSc-ILD) n = 576 |
INBUILD (Progressive fibrosing ILD) n = 663 |
---|---|---|---|---|---|
Age, years | 65 (8.4) | 67 (8.3) | 67 (7.8) | 54 (12.2) | 66 (9.8) |
Body weight, kg | 77 (14.7) | 82 (16.6) | 77 (16.1) | 70 (15.9) | 77 (17.4) |
Height, cm | 167 (9.0) | 169 (8.9) | 167 (9.4) | 164 (9.8) | 165 (10.0) |
FVC, % predicted | 82 (17.9) | 80 (17.1) | 79 (18.4) | 73 (16.7) | 69 (15.6) |
Race, n (%) | |||||
White | 270 (79) | 333 (65) | 275 (50) | 387 (67) | 488 (74) |
Black | 0 | 0 | 2 (< 1) | 36 (6) | 10 (2) |
Asian | 72 (21) | 106 (21) | 214 (39) | 143 (25) | 163 (25) |
American Indian/Alaska native | 0 | 1 (< 1) | 1 (< 1) | 5 (1) | 0 |
Hawaiian/Pacific Islander | 0 | 0 | 0 | 1 (< 1) | 1 (< 1) |
Multiple | 0 | 0 | 0 | 4 (< 1) | 1 (< 1) |
Missing | 0 | 73 (14)b | 56 (10)b | 0 | 0 |
Region, n (%) | |||||
Asia | 73 (21) | 97 (19) | 225 (41) | 130 (23) | 155 (23) |
Europe | 202 (59) | 288 (56) | 187 (34) | 266 (46) | 301 (45) |
North America | 10 (3) | 70 (14) | 104 (19) | 142 (25) | 136 (21) |
Rest of the world | 57 (17) | 58 (11) | 32 (6) | 38 (7) | 71 (11) |
Underlying diagnosis (INBUILD STUDY), n (%) | |||||
HP | – | – | – | – | 173 (26) |
iNSiP | – | – | – | – | 125 (19) |
Unclassifiable IIP | – | – | – | – | 114 (17) |
Autoimmune ILDs | – | – | – | – | 170 (26) |
Other ILDs | – | – | – | – | 81 (12) |
Data are presented as mean (SD) unless otherwise stated
FVC forced vital capacity, HP hypersensitivity pneumonitis, IIP idiopathic interstitial pneumonia, ILD interstitial lung disease, iNSiP idiopathic nonspecific interstitial pneumonia, IPF idiopathic pulmonary fibrosis, SD standard deviation, SSc systemic sclerosis
aFrom 428 patients treated in the TOMORROW trial, 342 patients are shown (86 patients randomized to 50 mg nintedanib once daily were excluded from analysis)
bDue to local laws, race information was not collected for some patients with study site located in France