Table 1 Baseline characteristics and adverse outcomes of the 57 patients
Baseline characteristics and outcome events | Results |
|---|---|
Age, years | 75.4 ± 9.4 |
Sex | |
 Female, n (%) | 9 (16) |
 Male, n (%) | 48 (84) |
Body height, cm | 162.2 ± 7.7 |
Body weight, kg | 63.5 ± 10.8 |
Body mass index, kg/m2 | 24.0 (21.5 to 26.5) |
Body surface area, m2 | 1.67 ± 0.15 |
Charlson comorbidity index | 5 (3 to 6) |
Echocardiographic evidence of pulmonary hypertension, n (%) | 36 (63) |
Echocardiographic evidence of LV dysfunction, n (%) | 2 (4) |
Dyslipidaemia, n (%) | 26 (46) |
Chronic hepatitis B, n (%) | 6 (11) |
Chronic hepatitis C, n (%) | 5 (9) |
Other non-viral liver condition, n (%) | 3 (5) |
Fatty liver on baseline sonography, n (%) | 15 (26) |
Cigarette smoking status | |
 Never smoker, n (%) | 26 (46) |
 Current smoker, n (%) | 4 (7) |
 Former smoker, n (%) | 27 (47) |
Baseline plasma KL-6 level, ng/mL | 1.48 (0.55 to 2.82) |
Baseline plasma SPA level, pg/mL | 283.6 (157.3 to 435.4) |
Baseline oximetry breathing ambient air, % | 95 (93 to 97) |
Baseline DLCO, mmol/min/kPa | 2.78 (2.11 to 3.96) |
Baseline DLCO, % predicted | 55 (38 to 70) |
Baseline FVC, L | 2.02 ± 0.49 |
Baseline FVC, % predicted | 67 ± 12 |
Stages based on the GAP index | |
 Stage 1, n (%) | 14 (25) |
 Stage 2, n (%) | 31 (54) |
 Stage 3, n (%) | 12 (21) |
Nintedanib-related hepatic injury, n (%) | 24 (42) |
On-treatment AE-IPF, n (%) | 20 (35) |
On-treatment mortality, n (%) | 16 (28) |
Duration of nintedanib therapy, days | 345 (91 to 706) |
Time to first nintedanib-related hepatic injury, days | 69 (17 to 156) |
Time to first on-treatment AE-IPF, days | 238 (111 to 431) |
Time to on-treatment mortality, days | 486 (217 to 811) |
Time between plasma sampling and nintedanib initiation, days | 6 (0 to 28) |
Time between baseline pulmonary functions and nintedanib initiation, days | 28 (16 to 51) |
Time between plasma sampling and baseline pulmonary functions, days | 24 (12 to 81) |
Annual rate of change in FVC, L/52 weeks | − 0.13 (− 0.26 to + 0.06) |
Annual rate of change in DLCO, % predicted/52 weeks | − 9 (− 29 to − 2) |